Trial Outcomes & Findings for A Study Evaluating Quality of Life Parameters Following Use of Emergen-C (NCT NCT06654089)
NCT ID: NCT06654089
Last Updated: 2026-04-07
Results Overview
The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Mental fatigue domain had 4 items. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. The total domain score was calculated by summation of the scores of individual items and was ranged from 4 to 20 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the Baseline score from score at Week 12. A negative change from Baseline indicated improvement in fatigue.
COMPLETED
PHASE4
299 participants
Baseline and Week 12
2026-04-07
Participant Flow
This study was conducted at a single center in United States of America.
A total of 299 participants were enrolled and randomized into two treatment groups: 149 to the Emergen-C group and 150 to the Placebo group. A total of 146 participants from the Emergen-C group and 147 from the Placebo group completed the study.
Participant milestones
| Measure |
Emergen-C Core Super Orange Powder (Test Product)
Participants were instructed to take the study product as per label instructions. Participants consumed one sachet of Emergen-C Core Super Orange Powder stirred in 4-6 ounces of water, orally, once daily for up to 12 weeks.
|
Placebo (Reference Product)
Participants were instructed to take the study product as per label instructions. Participants consumed one sachet of placebo stirred in 4-6 ounces of water, orally, once daily for up to 12 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
149
|
150
|
|
Overall Study
COMPLETED
|
146
|
147
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
| Measure |
Emergen-C Core Super Orange Powder (Test Product)
Participants were instructed to take the study product as per label instructions. Participants consumed one sachet of Emergen-C Core Super Orange Powder stirred in 4-6 ounces of water, orally, once daily for up to 12 weeks.
|
Placebo (Reference Product)
Participants were instructed to take the study product as per label instructions. Participants consumed one sachet of placebo stirred in 4-6 ounces of water, orally, once daily for up to 12 weeks.
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Study Treatment Package was not delivered
|
2
|
0
|
Baseline Characteristics
A Study Evaluating Quality of Life Parameters Following Use of Emergen-C
Baseline characteristics by cohort
| Measure |
Emergen-C Core Super Orange Powder (Test Product)
n=147 Participants
Participants were instructed to take the study product as per label instructions. Participants consumed one sachet of Emergen-C Core Super Orange Powder stirred in 4-6 ounces of water, orally, once daily for up to 12 weeks.
|
Placebo (Reference Product)
n=150 Participants
Participants were instructed to take the study product as per label instructions. Participants consumed one sachet of placebo stirred in 4-6 ounces of water, orally, once daily for up to 12 weeks.
|
Total
n=297 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
42.1 years
STANDARD_DEVIATION 10.89 • n=527 Participants
|
41.7 years
STANDARD_DEVIATION 11.26 • n=527 Participants
|
41.9 years
STANDARD_DEVIATION 11.06 • n=1054 Participants
|
|
Sex: Female, Male
Female
|
109 Participants
n=527 Participants
|
121 Participants
n=527 Participants
|
230 Participants
n=1054 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=527 Participants
|
29 Participants
n=527 Participants
|
67 Participants
n=1054 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
3 Participants
n=527 Participants
|
0 Participants
n=527 Participants
|
3 Participants
n=1054 Participants
|
|
Race/Ethnicity, Customized
Asian
|
13 Participants
n=527 Participants
|
12 Participants
n=527 Participants
|
25 Participants
n=1054 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
45 Participants
n=527 Participants
|
43 Participants
n=527 Participants
|
88 Participants
n=1054 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
0 Participants
n=527 Participants
|
4 Participants
n=527 Participants
|
4 Participants
n=1054 Participants
|
|
Race/Ethnicity, Customized
Latin
|
0 Participants
n=527 Participants
|
1 Participants
n=527 Participants
|
1 Participants
n=1054 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
8 Participants
n=527 Participants
|
8 Participants
n=527 Participants
|
16 Participants
n=1054 Participants
|
|
Race/Ethnicity, Customized
White
|
77 Participants
n=527 Participants
|
82 Participants
n=527 Participants
|
159 Participants
n=1054 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=527 Participants
|
0 Participants
n=527 Participants
|
1 Participants
n=1054 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: The modified Intention-To-Treat (mITT) population consisted of all participants who were randomized, completed the Baseline visit, completed at least one-post Baseline MFI domain assessment, and took at least one dose of their allocated randomized product. Only those participants with data available at the specified time point were analyzed.
The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. General fatigue domain had 4 items. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. The total domain score was calculated by summation of the scores of individual items and ranged from 4 to 20 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the Baseline score from score at Week 12. A negative change from Baseline indicated improvement in fatigue.
Outcome measures
| Measure |
Placebo (Reference Product)
n=147 Participants
Participants were instructed to take the study product as per label instructions. Participants consumed one sachet of placebo stirred in 4-6 ounces of water, orally, once daily for up to 12 weeks.
|
Emergen-C Core Super Orange Powder (Test Product)
n=146 Participants
Participants were instructed to take the study product as per label instructions. Participants consumed one sachet of Emergen-C Core Super Orange Powder stirred in 4-6 ounces of water, orally, once daily for up to 12 weeks.
|
|---|---|---|
|
Adjusted Mean Change From Baseline in Multidimensional Fatigue Inventory (MFI) General Fatigue Domain Score at Week 12
|
-5.48 score on a scale
Standard Error 0.29
|
-5.23 score on a scale
Standard Error 0.29
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: mITT population. Only those participants with data available at the specified time point were analyzed.
The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Physical fatigue domain had 4 items. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reverse scored and negatively phrased items were scored at face value. The total domain score was calculated by summation of the scores of individual items and was ranged from 4 to 20 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the Baseline score from score at Week 12. A negative change from Baseline indicated improvement in fatigue.
Outcome measures
| Measure |
Placebo (Reference Product)
n=147 Participants
Participants were instructed to take the study product as per label instructions. Participants consumed one sachet of placebo stirred in 4-6 ounces of water, orally, once daily for up to 12 weeks.
|
Emergen-C Core Super Orange Powder (Test Product)
n=146 Participants
Participants were instructed to take the study product as per label instructions. Participants consumed one sachet of Emergen-C Core Super Orange Powder stirred in 4-6 ounces of water, orally, once daily for up to 12 weeks.
|
|---|---|---|
|
Adjusted Mean Change From Baseline in MFI Physical Fatigue Domain Score at Week 12
|
-3.95 score on a scale
Standard Error 0.26
|
-3.75 score on a scale
Standard Error 0.27
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: mITT population. Only those participants with data available at the specified time point were analyzed.
The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Reduced activity domain had 4 items. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. The total domain score was calculated by summation of the scores of individual items and was ranged from 4 to 20 where lower scores indicated lower level of fatigue symptoms. Change from Baseline was calculated by subtracting the Baseline score from score at Week 12. A negative change from Baseline indicated improvement in symptoms.
Outcome measures
| Measure |
Placebo (Reference Product)
n=147 Participants
Participants were instructed to take the study product as per label instructions. Participants consumed one sachet of placebo stirred in 4-6 ounces of water, orally, once daily for up to 12 weeks.
|
Emergen-C Core Super Orange Powder (Test Product)
n=146 Participants
Participants were instructed to take the study product as per label instructions. Participants consumed one sachet of Emergen-C Core Super Orange Powder stirred in 4-6 ounces of water, orally, once daily for up to 12 weeks.
|
|---|---|---|
|
Adjusted Mean Change From Baseline in MFI Reduced Activity Domain Score at Week 12
|
-3.96 score on a scale
Standard Error 0.28
|
-3.68 score on a scale
Standard Error 0.28
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: mITT population. Only those participants with data available at the specified time point were analyzed.
The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Reduced motivation domain had 4 items. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. The total domain score was calculated by summation of the scores of individual items and was ranged from 4 to 20 where lower scores indicated lower level of fatigue symptoms. Change from Baseline was calculated by subtracting the Baseline score from score at Week 12. A negative change from Baseline indicated improvement in symptoms.
Outcome measures
| Measure |
Placebo (Reference Product)
n=147 Participants
Participants were instructed to take the study product as per label instructions. Participants consumed one sachet of placebo stirred in 4-6 ounces of water, orally, once daily for up to 12 weeks.
|
Emergen-C Core Super Orange Powder (Test Product)
n=146 Participants
Participants were instructed to take the study product as per label instructions. Participants consumed one sachet of Emergen-C Core Super Orange Powder stirred in 4-6 ounces of water, orally, once daily for up to 12 weeks.
|
|---|---|---|
|
Adjusted Mean Change From Baseline in MFI Reduced Motivation Domain Score at Week 12
|
-4.09 score on a scale
Standard Error 0.26
|
-3.83 score on a scale
Standard Error 0.26
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: mITT population. Only those participants with data available at the specified time point were analyzed.
The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Mental fatigue domain had 4 items. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. The total domain score was calculated by summation of the scores of individual items and was ranged from 4 to 20 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the Baseline score from score at Week 12. A negative change from Baseline indicated improvement in fatigue.
Outcome measures
| Measure |
Placebo (Reference Product)
n=147 Participants
Participants were instructed to take the study product as per label instructions. Participants consumed one sachet of placebo stirred in 4-6 ounces of water, orally, once daily for up to 12 weeks.
|
Emergen-C Core Super Orange Powder (Test Product)
n=146 Participants
Participants were instructed to take the study product as per label instructions. Participants consumed one sachet of Emergen-C Core Super Orange Powder stirred in 4-6 ounces of water, orally, once daily for up to 12 weeks.
|
|---|---|---|
|
Adjusted Mean Change From Baseline in MFI Mental Fatigue Domain Score at Week 12
|
-3.83 score on a scale
Standard Error 0.29
|
-4.25 score on a scale
Standard Error 0.29
|
SECONDARY outcome
Timeframe: Baseline, Week 4 and Week 8Population: mITT population. Only those participants with data available at the specified time point were analyzed.
The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. General fatigue domain had 4 items. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. The total domain score was calculated by summation of the scores of individual items and was ranged from 4 to 20 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the Baseline score from score at Week 12. A negative change from Baseline indicated improvement in fatigue.
Outcome measures
| Measure |
Placebo (Reference Product)
n=149 Participants
Participants were instructed to take the study product as per label instructions. Participants consumed one sachet of placebo stirred in 4-6 ounces of water, orally, once daily for up to 12 weeks.
|
Emergen-C Core Super Orange Powder (Test Product)
n=147 Participants
Participants were instructed to take the study product as per label instructions. Participants consumed one sachet of Emergen-C Core Super Orange Powder stirred in 4-6 ounces of water, orally, once daily for up to 12 weeks.
|
|---|---|---|
|
Adjusted Mean Change From Baseline in MFI General Fatigue Domain Score at Weeks 4 and 8
Week 4
|
-4.57 score on a scale
Standard Error 0.29
|
-4.14 score on a scale
Standard Error 0.29
|
|
Adjusted Mean Change From Baseline in MFI General Fatigue Domain Score at Weeks 4 and 8
Week 8
|
-5.13 score on a scale
Standard Error 0.29
|
-4.73 score on a scale
Standard Error 0.29
|
SECONDARY outcome
Timeframe: Baseline, Week 4 and Week 8Population: mITT population. Only those participants with data available at the specified time point were analyzed.
The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Physical fatigue domain had 4 items. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reverse scored and negatively phrased items were scored at face value. The total domain score was calculated by summation of the scores of individual items and was ranged from 4 to 20 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the Baseline score from score at Week 12. A negative change from Baseline indicated improvement in fatigue.
Outcome measures
| Measure |
Placebo (Reference Product)
n=149 Participants
Participants were instructed to take the study product as per label instructions. Participants consumed one sachet of placebo stirred in 4-6 ounces of water, orally, once daily for up to 12 weeks.
|
Emergen-C Core Super Orange Powder (Test Product)
n=147 Participants
Participants were instructed to take the study product as per label instructions. Participants consumed one sachet of Emergen-C Core Super Orange Powder stirred in 4-6 ounces of water, orally, once daily for up to 12 weeks.
|
|---|---|---|
|
Adjusted Mean Change From Baseline in MFI Physical Fatigue Domain Score at Weeks 4 and 8
Week 4
|
-3.13 score on a scale
Standard Error 0.26
|
-2.85 score on a scale
Standard Error 0.27
|
|
Adjusted Mean Change From Baseline in MFI Physical Fatigue Domain Score at Weeks 4 and 8
Week 8
|
-3.74 score on a scale
Standard Error 0.26
|
-3.34 score on a scale
Standard Error 0.27
|
SECONDARY outcome
Timeframe: Baseline, Week 4 and Week 8Population: mITT population. Only those participants with data available at the specified time point were analyzed.
The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Reduced activity domain had 4 items. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. The total domain score was calculated by summation of the scores of individual items and was ranged from 4 to 20 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the Baseline score from score at Week 12. A negative change from Baseline indicated improvement in fatigue.
Outcome measures
| Measure |
Placebo (Reference Product)
n=149 Participants
Participants were instructed to take the study product as per label instructions. Participants consumed one sachet of placebo stirred in 4-6 ounces of water, orally, once daily for up to 12 weeks.
|
Emergen-C Core Super Orange Powder (Test Product)
n=147 Participants
Participants were instructed to take the study product as per label instructions. Participants consumed one sachet of Emergen-C Core Super Orange Powder stirred in 4-6 ounces of water, orally, once daily for up to 12 weeks.
|
|---|---|---|
|
Adjusted Mean Change From Baseline in MFI Reduced Activity Domain Score at Weeks 4 and 8
Week 4
|
-3.00 score on a scale
Standard Error 0.28
|
-2.96 score on a scale
Standard Error 0.28
|
|
Adjusted Mean Change From Baseline in MFI Reduced Activity Domain Score at Weeks 4 and 8
Week 8
|
-3.44 score on a scale
Standard Error 0.28
|
-3.39 score on a scale
Standard Error 0.28
|
SECONDARY outcome
Timeframe: Baseline, Week 4 and Week 8Population: mITT population. Only those participants with data available at the specified time point were analyzed.
The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Reduced motivation domain had 4 items. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. The total domain score was calculated by summation of the scores of individual items and was ranged from 4 to 20 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the Baseline score from score at Week 12. A negative change from Baseline indicated improvement in fatigue.
Outcome measures
| Measure |
Placebo (Reference Product)
n=149 Participants
Participants were instructed to take the study product as per label instructions. Participants consumed one sachet of placebo stirred in 4-6 ounces of water, orally, once daily for up to 12 weeks.
|
Emergen-C Core Super Orange Powder (Test Product)
n=147 Participants
Participants were instructed to take the study product as per label instructions. Participants consumed one sachet of Emergen-C Core Super Orange Powder stirred in 4-6 ounces of water, orally, once daily for up to 12 weeks.
|
|---|---|---|
|
Adjusted Mean Change From Baseline in MFI Reduced Motivation Domain Score at Weeks 4 and 8
Week 4
|
-3.00 score on a scale
Standard Error 0.26
|
-2.74 score on a scale
Standard Error 0.26
|
|
Adjusted Mean Change From Baseline in MFI Reduced Motivation Domain Score at Weeks 4 and 8
Week 8
|
-3.37 score on a scale
Standard Error 0.26
|
-3.24 score on a scale
Standard Error 0.26
|
SECONDARY outcome
Timeframe: Baseline, Week 4 and Week 8Population: mITT population. Only those participants with data available at the specified time point were analyzed.
The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Mental fatigue domain had 4 items. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. The total domain score was calculated by summation of the scores of individual items and was ranged from 4 to 20 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the Baseline score from score at Week 12. A negative change from Baseline indicated improvement in fatigue.
Outcome measures
| Measure |
Placebo (Reference Product)
n=149 Participants
Participants were instructed to take the study product as per label instructions. Participants consumed one sachet of placebo stirred in 4-6 ounces of water, orally, once daily for up to 12 weeks.
|
Emergen-C Core Super Orange Powder (Test Product)
n=147 Participants
Participants were instructed to take the study product as per label instructions. Participants consumed one sachet of Emergen-C Core Super Orange Powder stirred in 4-6 ounces of water, orally, once daily for up to 12 weeks.
|
|---|---|---|
|
Adjusted Mean Change From Baseline in MFI Mental Fatigue Domain Score at Weeks 4 and 8
Week 4
|
-3.40 score on a scale
Standard Error 0.29
|
-3.16 score on a scale
Standard Error 0.29
|
|
Adjusted Mean Change From Baseline in MFI Mental Fatigue Domain Score at Weeks 4 and 8
Week 8
|
-3.79 score on a scale
Standard Error 0.29
|
-3.58 score on a scale
Standard Error 0.29
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8 and 12Population: mITT population. Only those participants with data available at the specified time point were analyzed.
The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. Each individual item score was ranged from 1 to 5 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the individual MFI item score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in fatigue.
Outcome measures
| Measure |
Placebo (Reference Product)
n=149 Participants
Participants were instructed to take the study product as per label instructions. Participants consumed one sachet of placebo stirred in 4-6 ounces of water, orally, once daily for up to 12 weeks.
|
Emergen-C Core Super Orange Powder (Test Product)
n=147 Participants
Participants were instructed to take the study product as per label instructions. Participants consumed one sachet of Emergen-C Core Super Orange Powder stirred in 4-6 ounces of water, orally, once daily for up to 12 weeks.
|
|---|---|---|
|
Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I Feel Fit
Week 4
|
-0.47 score on a scale
Standard Error 0.08
|
-0.45 score on a scale
Standard Error 0.08
|
|
Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I Feel Fit
Week 8
|
-0.76 score on a scale
Standard Error 0.08
|
-0.46 score on a scale
Standard Error 0.08
|
|
Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I Feel Fit
Week 12
|
-0.76 score on a scale
Standard Error 0.08
|
-0.71 score on a scale
Standard Error 0.08
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8 and 12Population: mITT population. Only those participants with data available at the specified time point were analyzed.
The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. Each individual item score was ranged from 1 to 5 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the individual MFI item score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in fatigue.
Outcome measures
| Measure |
Placebo (Reference Product)
n=149 Participants
Participants were instructed to take the study product as per label instructions. Participants consumed one sachet of placebo stirred in 4-6 ounces of water, orally, once daily for up to 12 weeks.
|
Emergen-C Core Super Orange Powder (Test Product)
n=147 Participants
Participants were instructed to take the study product as per label instructions. Participants consumed one sachet of Emergen-C Core Super Orange Powder stirred in 4-6 ounces of water, orally, once daily for up to 12 weeks.
|
|---|---|---|
|
Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: Physically I Feel Only Able to do a Little
Week 4
|
-0.80 score on a scale
Standard Error 0.09
|
-0.70 score on a scale
Standard Error 0.09
|
|
Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: Physically I Feel Only Able to do a Little
Week 8
|
-0.88 score on a scale
Standard Error 0.09
|
-0.88 score on a scale
Standard Error 0.09
|
|
Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: Physically I Feel Only Able to do a Little
Week 12
|
-0.98 score on a scale
Standard Error 0.09
|
-0.93 score on a scale
Standard Error 0.09
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8 and 12Population: mITT population. Only those participants with data available at the specified time point were analyzed.
The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. Each individual item score was ranged from 1 to 5 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the individual MFI item score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in fatigue.
Outcome measures
| Measure |
Placebo (Reference Product)
n=149 Participants
Participants were instructed to take the study product as per label instructions. Participants consumed one sachet of placebo stirred in 4-6 ounces of water, orally, once daily for up to 12 weeks.
|
Emergen-C Core Super Orange Powder (Test Product)
n=147 Participants
Participants were instructed to take the study product as per label instructions. Participants consumed one sachet of Emergen-C Core Super Orange Powder stirred in 4-6 ounces of water, orally, once daily for up to 12 weeks.
|
|---|---|---|
|
Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I Feel Very Active
Week 4
|
-0.70 score on a scale
Standard Error 0.09
|
-0.69 score on a scale
Standard Error 0.09
|
|
Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I Feel Very Active
Week 8
|
-0.87 score on a scale
Standard Error 0.08
|
-0.84 score on a scale
Standard Error 0.09
|
|
Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I Feel Very Active
Week 12
|
-1.03 score on a scale
Standard Error 0.09
|
-0.93 score on a scale
Standard Error 0.09
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8 and 12Population: mITT population. Only those participants with data available at the specified time point were analyzed.
The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. Each individual item score was ranged from 1 to 5 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the individual MFI item score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in fatigue.
Outcome measures
| Measure |
Placebo (Reference Product)
n=149 Participants
Participants were instructed to take the study product as per label instructions. Participants consumed one sachet of placebo stirred in 4-6 ounces of water, orally, once daily for up to 12 weeks.
|
Emergen-C Core Super Orange Powder (Test Product)
n=147 Participants
Participants were instructed to take the study product as per label instructions. Participants consumed one sachet of Emergen-C Core Super Orange Powder stirred in 4-6 ounces of water, orally, once daily for up to 12 weeks.
|
|---|---|---|
|
Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I Feel Like Doing All Sorts of Nice Things
Week 4
|
-0.58 score on a scale
Standard Error 0.08
|
-0.59 score on a scale
Standard Error 0.08
|
|
Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I Feel Like Doing All Sorts of Nice Things
Week 8
|
-0.71 score on a scale
Standard Error 0.08
|
-0.60 score on a scale
Standard Error 0.08
|
|
Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I Feel Like Doing All Sorts of Nice Things
Week 12
|
-0.99 score on a scale
Standard Error 0.08
|
-0.81 score on a scale
Standard Error 0.08
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8 and 12Population: mITT population. Only those participants with data available at the specified time point were analyzed.
The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. Each individual item score was ranged from 1 to 5 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the individual MFI item score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in fatigue.
Outcome measures
| Measure |
Placebo (Reference Product)
n=149 Participants
Participants were instructed to take the study product as per label instructions. Participants consumed one sachet of placebo stirred in 4-6 ounces of water, orally, once daily for up to 12 weeks.
|
Emergen-C Core Super Orange Powder (Test Product)
n=147 Participants
Participants were instructed to take the study product as per label instructions. Participants consumed one sachet of Emergen-C Core Super Orange Powder stirred in 4-6 ounces of water, orally, once daily for up to 12 weeks.
|
|---|---|---|
|
Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I Feel Tired
Week 4
|
-1.39 score on a scale
Standard Error 0.09
|
-1.29 score on a scale
Standard Error 0.09
|
|
Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I Feel Tired
Week 8
|
-1.50 score on a scale
Standard Error 0.09
|
-1.48 score on a scale
Standard Error 0.10
|
|
Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I Feel Tired
Week 12
|
-1.68 score on a scale
Standard Error 0.09
|
-1.60 score on a scale
Standard Error 0.10
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8 and 12Population: mITT population. Only those participants with data available at the specified time point were analyzed.
The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. Each individual item score was ranged from 1 to 5 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the individual MFI item score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in fatigue.
Outcome measures
| Measure |
Placebo (Reference Product)
n=149 Participants
Participants were instructed to take the study product as per label instructions. Participants consumed one sachet of placebo stirred in 4-6 ounces of water, orally, once daily for up to 12 weeks.
|
Emergen-C Core Super Orange Powder (Test Product)
n=147 Participants
Participants were instructed to take the study product as per label instructions. Participants consumed one sachet of Emergen-C Core Super Orange Powder stirred in 4-6 ounces of water, orally, once daily for up to 12 weeks.
|
|---|---|---|
|
Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I Think I do a Lot in a Day
Week 4
|
-0.55 score on a scale
Standard Error 0.09
|
-0.59 score on a scale
Standard Error 0.09
|
|
Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I Think I do a Lot in a Day
Week 8
|
-0.56 score on a scale
Standard Error 0.09
|
-0.61 score on a scale
Standard Error 0.09
|
|
Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I Think I do a Lot in a Day
Week 12
|
-0.81 score on a scale
Standard Error 0.09
|
-0.70 score on a scale
Standard Error 0.09
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8 and 12Population: mITT population. Only those participants with data available at the specified time point were analyzed.
The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. Each individual item score was ranged from 1 to 5 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the individual MFI item score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in fatigue.
Outcome measures
| Measure |
Placebo (Reference Product)
n=149 Participants
Participants were instructed to take the study product as per label instructions. Participants consumed one sachet of placebo stirred in 4-6 ounces of water, orally, once daily for up to 12 weeks.
|
Emergen-C Core Super Orange Powder (Test Product)
n=147 Participants
Participants were instructed to take the study product as per label instructions. Participants consumed one sachet of Emergen-C Core Super Orange Powder stirred in 4-6 ounces of water, orally, once daily for up to 12 weeks.
|
|---|---|---|
|
Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: When I am Doing Something, I Can Keep my Thoughts on it
Week 8
|
-0.86 score on a scale
Standard Error 0.08
|
-0.80 score on a scale
Standard Error 0.08
|
|
Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: When I am Doing Something, I Can Keep my Thoughts on it
Week 12
|
-0.90 score on a scale
Standard Error 0.08
|
-0.92 score on a scale
Standard Error 0.08
|
|
Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: When I am Doing Something, I Can Keep my Thoughts on it
Week 4
|
-0.90 score on a scale
Standard Error 0.08
|
-0.67 score on a scale
Standard Error 0.08
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8 and 12Population: mITT population. Only those participants with data available at the specified time point were analyzed.
The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. Each individual item score was ranged from 1 to 5 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the individual MFI item score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in fatigue.
Outcome measures
| Measure |
Placebo (Reference Product)
n=149 Participants
Participants were instructed to take the study product as per label instructions. Participants consumed one sachet of placebo stirred in 4-6 ounces of water, orally, once daily for up to 12 weeks.
|
Emergen-C Core Super Orange Powder (Test Product)
n=147 Participants
Participants were instructed to take the study product as per label instructions. Participants consumed one sachet of Emergen-C Core Super Orange Powder stirred in 4-6 ounces of water, orally, once daily for up to 12 weeks.
|
|---|---|---|
|
Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: Physically I Can Take on a Lot
Week 4
|
-0.93 score on a scale
Standard Error 0.08
|
-0.88 score on a scale
Standard Error 0.08
|
|
Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: Physically I Can Take on a Lot
Week 8
|
-1.06 score on a scale
Standard Error 0.08
|
-0.93 score on a scale
Standard Error 0.08
|
|
Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: Physically I Can Take on a Lot
Week 12
|
-1.05 score on a scale
Standard Error 0.08
|
-1.08 score on a scale
Standard Error 0.08
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8 and 12Population: mITT population. Only those participants with data available at the specified time point were analyzed.
The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. Each individual item score was ranged from 1 to 5 where lower scores indicated lower level of fatigue symptoms. Change from Baseline was calculated by subtracting the individual MFI item score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in fatigue symptoms.
Outcome measures
| Measure |
Placebo (Reference Product)
n=149 Participants
Participants were instructed to take the study product as per label instructions. Participants consumed one sachet of placebo stirred in 4-6 ounces of water, orally, once daily for up to 12 weeks.
|
Emergen-C Core Super Orange Powder (Test Product)
n=147 Participants
Participants were instructed to take the study product as per label instructions. Participants consumed one sachet of Emergen-C Core Super Orange Powder stirred in 4-6 ounces of water, orally, once daily for up to 12 weeks.
|
|---|---|---|
|
Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I Dread Having to do Things
Week 12
|
-1.09 score on a scale
Standard Error 0.10
|
-1.11 score on a scale
Standard Error 0.10
|
|
Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I Dread Having to do Things
Week 4
|
-0.88 score on a scale
Standard Error 0.09
|
-0.73 score on a scale
Standard Error 0.10
|
|
Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I Dread Having to do Things
Week 8
|
-0.96 score on a scale
Standard Error 0.09
|
-0.95 score on a scale
Standard Error 0.10
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8 and 12Population: mITT population. Only those participants with data available at the specified time point were analyzed.
The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. Each individual item score was ranged from 1 to 5 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the individual MFI item score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in fatigue.
Outcome measures
| Measure |
Placebo (Reference Product)
n=149 Participants
Participants were instructed to take the study product as per label instructions. Participants consumed one sachet of placebo stirred in 4-6 ounces of water, orally, once daily for up to 12 weeks.
|
Emergen-C Core Super Orange Powder (Test Product)
n=147 Participants
Participants were instructed to take the study product as per label instructions. Participants consumed one sachet of Emergen-C Core Super Orange Powder stirred in 4-6 ounces of water, orally, once daily for up to 12 weeks.
|
|---|---|---|
|
Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I Think I do Very Little in a Day
Week 4
|
-0.84 score on a scale
Standard Error 0.09
|
-0.75 score on a scale
Standard Error 0.09
|
|
Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I Think I do Very Little in a Day
Week 12
|
-0.95 score on a scale
Standard Error 0.09
|
-0.96 score on a scale
Standard Error 0.09
|
|
Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I Think I do Very Little in a Day
Week 8
|
-0.88 score on a scale
Standard Error 0.09
|
-0.88 score on a scale
Standard Error 0.09
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8 and 12Population: mITT population. Only those participants with data available at the specified time point were analyzed.
The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. Each individual item score was ranged from 1 to 5 where lower scores indicated lower level of fatigue symptoms. Change from Baseline was calculated by subtracting the individual MFI item score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in fatigue symptoms.
Outcome measures
| Measure |
Placebo (Reference Product)
n=149 Participants
Participants were instructed to take the study product as per label instructions. Participants consumed one sachet of placebo stirred in 4-6 ounces of water, orally, once daily for up to 12 weeks.
|
Emergen-C Core Super Orange Powder (Test Product)
n=147 Participants
Participants were instructed to take the study product as per label instructions. Participants consumed one sachet of Emergen-C Core Super Orange Powder stirred in 4-6 ounces of water, orally, once daily for up to 12 weeks.
|
|---|---|---|
|
Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I Can Concentrate Well
Week 8
|
-0.86 score on a scale
Standard Error 0.08
|
-0.93 score on a scale
Standard Error 0.08
|
|
Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I Can Concentrate Well
Week 4
|
-0.79 score on a scale
Standard Error 0.08
|
-0.78 score on a scale
Standard Error 0.08
|
|
Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I Can Concentrate Well
Week 12
|
-0.90 score on a scale
Standard Error 0.08
|
-1.04 score on a scale
Standard Error 0.08
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8 and 12Population: mITT population. Only those participants with data available at the specified time point were analyzed.
The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. Each individual item score was ranged from 1 to 5 where lower scores indicated lower level of fatigue symptoms. Change from Baseline was calculated by subtracting the individual MFI item score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in fatigue symptoms.
Outcome measures
| Measure |
Placebo (Reference Product)
n=149 Participants
Participants were instructed to take the study product as per label instructions. Participants consumed one sachet of placebo stirred in 4-6 ounces of water, orally, once daily for up to 12 weeks.
|
Emergen-C Core Super Orange Powder (Test Product)
n=147 Participants
Participants were instructed to take the study product as per label instructions. Participants consumed one sachet of Emergen-C Core Super Orange Powder stirred in 4-6 ounces of water, orally, once daily for up to 12 weeks.
|
|---|---|---|
|
Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I am Rested
Week 4
|
-1.29 score on a scale
Standard Error 0.09
|
-1.17 score on a scale
Standard Error 0.09
|
|
Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I am Rested
Week 8
|
-1.39 score on a scale
Standard Error 0.09
|
-1.28 score on a scale
Standard Error 0.09
|
|
Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I am Rested
Week 12
|
-1.39 score on a scale
Standard Error 0.09
|
-1.40 score on a scale
Standard Error 0.09
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8 and 12Population: mITT population. Only those participants with data available at the specified time point were analyzed.
The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. Each individual item score was ranged from 1 to 5 where lower scores indicated lower level of fatigue symptoms. Change from Baseline was calculated by subtracting the individual MFI item score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in fatigue symptoms.
Outcome measures
| Measure |
Placebo (Reference Product)
n=149 Participants
Participants were instructed to take the study product as per label instructions. Participants consumed one sachet of placebo stirred in 4-6 ounces of water, orally, once daily for up to 12 weeks.
|
Emergen-C Core Super Orange Powder (Test Product)
n=147 Participants
Participants were instructed to take the study product as per label instructions. Participants consumed one sachet of Emergen-C Core Super Orange Powder stirred in 4-6 ounces of water, orally, once daily for up to 12 weeks.
|
|---|---|---|
|
Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: It Takes a Lot of Effort to Concentrate on Things
Week 4
|
-0.95 score on a scale
Standard Error 0.09
|
-1.02 score on a scale
Standard Error 0.09
|
|
Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: It Takes a Lot of Effort to Concentrate on Things
Week 8
|
-1.13 score on a scale
Standard Error 0.09
|
-1.07 score on a scale
Standard Error 0.09
|
|
Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: It Takes a Lot of Effort to Concentrate on Things
Week 12
|
-1.09 score on a scale
Standard Error 0.09
|
-1.29 score on a scale
Standard Error 0.09
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8 and 12Population: mITT population. Only those participants with data available at the specified time point were analyzed.
The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. Each individual item score was ranged from 1 to 5 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the individual MFI item score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in fatigue.
Outcome measures
| Measure |
Placebo (Reference Product)
n=149 Participants
Participants were instructed to take the study product as per label instructions. Participants consumed one sachet of placebo stirred in 4-6 ounces of water, orally, once daily for up to 12 weeks.
|
Emergen-C Core Super Orange Powder (Test Product)
n=147 Participants
Participants were instructed to take the study product as per label instructions. Participants consumed one sachet of Emergen-C Core Super Orange Powder stirred in 4-6 ounces of water, orally, once daily for up to 12 weeks.
|
|---|---|---|
|
Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: Physically I Feel I am in a Bad Condition
Week 4
|
-0.70 score on a scale
Standard Error 0.08
|
-0.67 score on a scale
Standard Error 0.08
|
|
Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: Physically I Feel I am in a Bad Condition
Week 8
|
-0.83 score on a scale
Standard Error 0.08
|
-0.74 score on a scale
Standard Error 0.08
|
|
Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: Physically I Feel I am in a Bad Condition
Week 12
|
-0.91 score on a scale
Standard Error 0.08
|
-0.87 score on a scale
Standard Error 0.08
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8 and 12Population: mITT population. Only those participants with data available at the specified time point were analyzed.
The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. Each individual item score was ranged from 1 to 5 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the individual MFI item score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in fatigue.
Outcome measures
| Measure |
Placebo (Reference Product)
n=149 Participants
Participants were instructed to take the study product as per label instructions. Participants consumed one sachet of placebo stirred in 4-6 ounces of water, orally, once daily for up to 12 weeks.
|
Emergen-C Core Super Orange Powder (Test Product)
n=147 Participants
Participants were instructed to take the study product as per label instructions. Participants consumed one sachet of Emergen-C Core Super Orange Powder stirred in 4-6 ounces of water, orally, once daily for up to 12 weeks.
|
|---|---|---|
|
Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I Have a Lot of Plans
Week 4
|
-0.36 score on a scale
Standard Error 0.08
|
-0.30 score on a scale
Standard Error 0.08
|
|
Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I Have a Lot of Plans
Week 8
|
-0.45 score on a scale
Standard Error 0.08
|
-0.41 score on a scale
Standard Error 0.08
|
|
Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I Have a Lot of Plans
Week 12
|
-0.52 score on a scale
Standard Error 0.08
|
-0.51 score on a scale
Standard Error 0.08
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8 and 12Population: mITT population. Only those participants with data available at the specified time point were analyzed.
The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. Each individual item score was ranged from 1 to 5 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the individual MFI item score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in fatigue.
Outcome measures
| Measure |
Placebo (Reference Product)
n=149 Participants
Participants were instructed to take the study product as per label instructions. Participants consumed one sachet of placebo stirred in 4-6 ounces of water, orally, once daily for up to 12 weeks.
|
Emergen-C Core Super Orange Powder (Test Product)
n=147 Participants
Participants were instructed to take the study product as per label instructions. Participants consumed one sachet of Emergen-C Core Super Orange Powder stirred in 4-6 ounces of water, orally, once daily for up to 12 weeks.
|
|---|---|---|
|
Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I Tire Easily
Week 4
|
-1.39 score on a scale
Standard Error 0.10
|
-1.26 score on a scale
Standard Error 0.10
|
|
Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I Tire Easily
Week 8
|
-1.44 score on a scale
Standard Error 0.10
|
-1.54 score on a scale
Standard Error 0.10
|
|
Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I Tire Easily
Week 12
|
-1.62 score on a scale
Standard Error 0.10
|
-1.55 score on a scale
Standard Error 0.10
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8 and 12Population: mITT population. Only those participants with data available at the specified time point were analyzed.
The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. Each individual item score was ranged from 1 to 5 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the individual MFI item score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in fatigue.
Outcome measures
| Measure |
Placebo (Reference Product)
n=149 Participants
Participants were instructed to take the study product as per label instructions. Participants consumed one sachet of placebo stirred in 4-6 ounces of water, orally, once daily for up to 12 weeks.
|
Emergen-C Core Super Orange Powder (Test Product)
n=147 Participants
Participants were instructed to take the study product as per label instructions. Participants consumed one sachet of Emergen-C Core Super Orange Powder stirred in 4-6 ounces of water, orally, once daily for up to 12 weeks.
|
|---|---|---|
|
Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I Get Little Done
Week 4
|
-0.90 score on a scale
Standard Error 0.08
|
-0.94 score on a scale
Standard Error 0.08
|
|
Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I Get Little Done
Week 8
|
-1.10 score on a scale
Standard Error 0.08
|
-1.08 score on a scale
Standard Error 0.08
|
|
Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I Get Little Done
Week 12
|
-1.15 score on a scale
Standard Error 0.08
|
-1.10 score on a scale
Standard Error 0.08
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8 and 12Population: mITT population. Only those participants with data available at the specified time point were analyzed.
The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. Each individual item score was ranged from 1 to 5 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the individual MFI item score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in fatigue.
Outcome measures
| Measure |
Placebo (Reference Product)
n=149 Participants
Participants were instructed to take the study product as per label instructions. Participants consumed one sachet of placebo stirred in 4-6 ounces of water, orally, once daily for up to 12 weeks.
|
Emergen-C Core Super Orange Powder (Test Product)
n=147 Participants
Participants were instructed to take the study product as per label instructions. Participants consumed one sachet of Emergen-C Core Super Orange Powder stirred in 4-6 ounces of water, orally, once daily for up to 12 weeks.
|
|---|---|---|
|
Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I Don't Feel Like Doing Anything
Week 4
|
-1.17 score on a scale
Standard Error 0.10
|
-1.13 score on a scale
Standard Error 0.10
|
|
Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I Don't Feel Like Doing Anything
Week 8
|
-1.24 score on a scale
Standard Error 0.10
|
-1.29 score on a scale
Standard Error 0.10
|
|
Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I Don't Feel Like Doing Anything
Week 12
|
-1.48 score on a scale
Standard Error 0.10
|
-1.41 score on a scale
Standard Error 0.10
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8 and 12Population: mITT population. Only those participants with data available at the specified time point were analyzed.
The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. Each individual item score was ranged from 1 to 5 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the individual MFI item score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in fatigue.
Outcome measures
| Measure |
Placebo (Reference Product)
n=149 Participants
Participants were instructed to take the study product as per label instructions. Participants consumed one sachet of placebo stirred in 4-6 ounces of water, orally, once daily for up to 12 weeks.
|
Emergen-C Core Super Orange Powder (Test Product)
n=147 Participants
Participants were instructed to take the study product as per label instructions. Participants consumed one sachet of Emergen-C Core Super Orange Powder stirred in 4-6 ounces of water, orally, once daily for up to 12 weeks.
|
|---|---|---|
|
Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: My Thoughts Easily Wander
Week 4
|
-0.74 score on a scale
Standard Error 0.10
|
-0.71 score on a scale
Standard Error 0.10
|
|
Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: My Thoughts Easily Wander
Week 8
|
-0.93 score on a scale
Standard Error 0.10
|
-0.81 score on a scale
Standard Error 0.10
|
|
Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: My Thoughts Easily Wander
Week 12
|
-0.92 score on a scale
Standard Error 0.10
|
-1.03 score on a scale
Standard Error 0.10
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8 and 12Population: mITT population. Only those participants with data available at the specified time point were analyzed.
The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. Each individual item score was ranged from 1 to 5 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the individual MFI item score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in fatigue.
Outcome measures
| Measure |
Placebo (Reference Product)
n=149 Participants
Participants were instructed to take the study product as per label instructions. Participants consumed one sachet of placebo stirred in 4-6 ounces of water, orally, once daily for up to 12 weeks.
|
Emergen-C Core Super Orange Powder (Test Product)
n=147 Participants
Participants were instructed to take the study product as per label instructions. Participants consumed one sachet of Emergen-C Core Super Orange Powder stirred in 4-6 ounces of water, orally, once daily for up to 12 weeks.
|
|---|---|---|
|
Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: Physically I Feel I am in an Excellent Condition
Week 4
|
-0.68 score on a scale
Standard Error 0.09
|
-0.61 score on a scale
Standard Error 0.09
|
|
Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: Physically I Feel I am in an Excellent Condition
Week 8
|
-0.96 score on a scale
Standard Error 0.09
|
-0.81 score on a scale
Standard Error 0.09
|
|
Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: Physically I Feel I am in an Excellent Condition
Week 12
|
-0.99 score on a scale
Standard Error 0.09
|
-0.89 score on a scale
Standard Error 0.09
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8 and 12Population: mITT population. Only those participants with data available at the specified time point were analyzed.
Participants answered 2 QoL questions related to Family support domain and indicated how they felt about each statement, on a scale of 1 (yes, that is true) to 5 (no, that is not true). The total domain score was calculated by summation of the scores of individual items and was ranged from 2 to 10 where QoL lower scores indicated better quality of life. Change from Baseline was calculated by subtracting the individual question score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in quality of life.
Outcome measures
| Measure |
Placebo (Reference Product)
n=149 Participants
Participants were instructed to take the study product as per label instructions. Participants consumed one sachet of placebo stirred in 4-6 ounces of water, orally, once daily for up to 12 weeks.
|
Emergen-C Core Super Orange Powder (Test Product)
n=147 Participants
Participants were instructed to take the study product as per label instructions. Participants consumed one sachet of Emergen-C Core Super Orange Powder stirred in 4-6 ounces of water, orally, once daily for up to 12 weeks.
|
|---|---|---|
|
Change From Baseline in Additional QoL Parameter at Weeks 4, 8 and 12: Family Support
Week 12
|
-1.98 score on a scale
Standard Error 0.15
|
-1.73 score on a scale
Standard Error 0.15
|
|
Change From Baseline in Additional QoL Parameter at Weeks 4, 8 and 12: Family Support
Week 4
|
-1.34 score on a scale
Standard Error 0.15
|
-1.17 score on a scale
Standard Error 0.15
|
|
Change From Baseline in Additional QoL Parameter at Weeks 4, 8 and 12: Family Support
Week 8
|
-1.92 score on a scale
Standard Error 0.15
|
-1.63 score on a scale
Standard Error 0.15
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8 and 12Population: mITT population. Only those participants with data available at the specified time point were analyzed.
Participants answered 2 QoL questions related to resilience domain and indicated how they felt about each statement, on a scale of 1 (yes, that is true) to 5 (no, that is not true). The total domain score was calculated by summation of the scores of individual items and was ranged from 2 to 10 where QoL lower scores indicated better quality of life. Change from Baseline was calculated by subtracting the individual question score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in quality of life.
Outcome measures
| Measure |
Placebo (Reference Product)
n=149 Participants
Participants were instructed to take the study product as per label instructions. Participants consumed one sachet of placebo stirred in 4-6 ounces of water, orally, once daily for up to 12 weeks.
|
Emergen-C Core Super Orange Powder (Test Product)
n=147 Participants
Participants were instructed to take the study product as per label instructions. Participants consumed one sachet of Emergen-C Core Super Orange Powder stirred in 4-6 ounces of water, orally, once daily for up to 12 weeks.
|
|---|---|---|
|
Change From Baseline in Additional QoL Parameter at Weeks 4, 8 and 12: Resilience
Week 4
|
-1.26 score on a scale
Standard Error 0.15
|
-1.19 score on a scale
Standard Error 0.15
|
|
Change From Baseline in Additional QoL Parameter at Weeks 4, 8 and 12: Resilience
Week 8
|
-1.74 score on a scale
Standard Error 0.15
|
-1.51 score on a scale
Standard Error 0.15
|
|
Change From Baseline in Additional QoL Parameter at Weeks 4, 8 and 12: Resilience
Week 12
|
-1.77 score on a scale
Standard Error 0.15
|
-1.73 score on a scale
Standard Error 0.15
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8 and 12Population: mITT population. Only those participants with data available at the specified time point were analyzed.
Participants answered 2 QoL questions related to 'Ability to relax and unwind' domain and indicated how they felt about each statement, on a scale of 1 (yes, that is true) to 5 (no, that is not true). The total domain score was calculated by summation of the scores of individual items and was ranged from 2 to 10 where QoL lower scores indicated better quality of life. Change from Baseline was calculated by subtracting the individual question score at Baseline from post-Baseline score at indicated timepoints. A negative change from Baseline indicated improvement in quality of life.
Outcome measures
| Measure |
Placebo (Reference Product)
n=149 Participants
Participants were instructed to take the study product as per label instructions. Participants consumed one sachet of placebo stirred in 4-6 ounces of water, orally, once daily for up to 12 weeks.
|
Emergen-C Core Super Orange Powder (Test Product)
n=147 Participants
Participants were instructed to take the study product as per label instructions. Participants consumed one sachet of Emergen-C Core Super Orange Powder stirred in 4-6 ounces of water, orally, once daily for up to 12 weeks.
|
|---|---|---|
|
Change From Baseline in Additional QoL Parameter at Weeks 4, 8 and 12: Ability to Relax and Unwind
Week 4
|
-1.42 score on a scale
Standard Error 0.16
|
-1.22 score on a scale
Standard Error 0.16
|
|
Change From Baseline in Additional QoL Parameter at Weeks 4, 8 and 12: Ability to Relax and Unwind
Week 8
|
-1.85 score on a scale
Standard Error 0.16
|
-1.67 score on a scale
Standard Error 0.16
|
|
Change From Baseline in Additional QoL Parameter at Weeks 4, 8 and 12: Ability to Relax and Unwind
Week 12
|
-1.67 score on a scale
Standard Error 0.16
|
-1.68 score on a scale
Standard Error 0.16
|
Adverse Events
Emergen-C Core Super Orange Powder (Test Product)
Placebo (Reference Product)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Emergen-C Core Super Orange Powder (Test Product)
n=147 participants at risk
Participants were instructed to take the study product as per label instructions. Participants consumed one sachet of Emergen-C Core Super Orange Powder stirred in 4-6 ounces of water, orally, once daily for up to 12 weeks.
|
Placebo (Reference Product)
n=150 participants at risk
Participants were instructed to take the study product as per label instructions. Participants consumed one sachet of placebo stirred in 4-6 ounces of water, orally, once daily for up to 12 weeks.
|
|---|---|---|
|
Gastrointestinal disorders
DIARRHOEA
|
0.68%
1/147 • Immediately after a participant was randomized within the trial and until 2 days following the last administration of study product (or the last study procedure) (approximately up to 86 days).
An AE was defined as any untoward medical occurrence in a study participant, temporally associated with the use of a study product whether or not considered related to the study product, including an acclimatization product (or medical device). A serious AE was a particular category of AE where the outcome was serious. Two participants in test group didn't take any study product as the treatment package was not delivered. Resulting 147 test and 150 Placebo participants in the Safety population.
|
1.3%
2/150 • Immediately after a participant was randomized within the trial and until 2 days following the last administration of study product (or the last study procedure) (approximately up to 86 days).
An AE was defined as any untoward medical occurrence in a study participant, temporally associated with the use of a study product whether or not considered related to the study product, including an acclimatization product (or medical device). A serious AE was a particular category of AE where the outcome was serious. Two participants in test group didn't take any study product as the treatment package was not delivered. Resulting 147 test and 150 Placebo participants in the Safety population.
|
|
Gastrointestinal disorders
NAUSEA
|
0.00%
0/147 • Immediately after a participant was randomized within the trial and until 2 days following the last administration of study product (or the last study procedure) (approximately up to 86 days).
An AE was defined as any untoward medical occurrence in a study participant, temporally associated with the use of a study product whether or not considered related to the study product, including an acclimatization product (or medical device). A serious AE was a particular category of AE where the outcome was serious. Two participants in test group didn't take any study product as the treatment package was not delivered. Resulting 147 test and 150 Placebo participants in the Safety population.
|
1.3%
2/150 • Immediately after a participant was randomized within the trial and until 2 days following the last administration of study product (or the last study procedure) (approximately up to 86 days).
An AE was defined as any untoward medical occurrence in a study participant, temporally associated with the use of a study product whether or not considered related to the study product, including an acclimatization product (or medical device). A serious AE was a particular category of AE where the outcome was serious. Two participants in test group didn't take any study product as the treatment package was not delivered. Resulting 147 test and 150 Placebo participants in the Safety population.
|
|
Gastrointestinal disorders
VOMITING
|
0.00%
0/147 • Immediately after a participant was randomized within the trial and until 2 days following the last administration of study product (or the last study procedure) (approximately up to 86 days).
An AE was defined as any untoward medical occurrence in a study participant, temporally associated with the use of a study product whether or not considered related to the study product, including an acclimatization product (or medical device). A serious AE was a particular category of AE where the outcome was serious. Two participants in test group didn't take any study product as the treatment package was not delivered. Resulting 147 test and 150 Placebo participants in the Safety population.
|
1.3%
2/150 • Immediately after a participant was randomized within the trial and until 2 days following the last administration of study product (or the last study procedure) (approximately up to 86 days).
An AE was defined as any untoward medical occurrence in a study participant, temporally associated with the use of a study product whether or not considered related to the study product, including an acclimatization product (or medical device). A serious AE was a particular category of AE where the outcome was serious. Two participants in test group didn't take any study product as the treatment package was not delivered. Resulting 147 test and 150 Placebo participants in the Safety population.
|
|
Gastrointestinal disorders
ABDOMINAL DISCOMFORT
|
0.00%
0/147 • Immediately after a participant was randomized within the trial and until 2 days following the last administration of study product (or the last study procedure) (approximately up to 86 days).
An AE was defined as any untoward medical occurrence in a study participant, temporally associated with the use of a study product whether or not considered related to the study product, including an acclimatization product (or medical device). A serious AE was a particular category of AE where the outcome was serious. Two participants in test group didn't take any study product as the treatment package was not delivered. Resulting 147 test and 150 Placebo participants in the Safety population.
|
0.67%
1/150 • Immediately after a participant was randomized within the trial and until 2 days following the last administration of study product (or the last study procedure) (approximately up to 86 days).
An AE was defined as any untoward medical occurrence in a study participant, temporally associated with the use of a study product whether or not considered related to the study product, including an acclimatization product (or medical device). A serious AE was a particular category of AE where the outcome was serious. Two participants in test group didn't take any study product as the treatment package was not delivered. Resulting 147 test and 150 Placebo participants in the Safety population.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
0.00%
0/147 • Immediately after a participant was randomized within the trial and until 2 days following the last administration of study product (or the last study procedure) (approximately up to 86 days).
An AE was defined as any untoward medical occurrence in a study participant, temporally associated with the use of a study product whether or not considered related to the study product, including an acclimatization product (or medical device). A serious AE was a particular category of AE where the outcome was serious. Two participants in test group didn't take any study product as the treatment package was not delivered. Resulting 147 test and 150 Placebo participants in the Safety population.
|
0.67%
1/150 • Immediately after a participant was randomized within the trial and until 2 days following the last administration of study product (or the last study procedure) (approximately up to 86 days).
An AE was defined as any untoward medical occurrence in a study participant, temporally associated with the use of a study product whether or not considered related to the study product, including an acclimatization product (or medical device). A serious AE was a particular category of AE where the outcome was serious. Two participants in test group didn't take any study product as the treatment package was not delivered. Resulting 147 test and 150 Placebo participants in the Safety population.
|
|
Gastrointestinal disorders
CONSTIPATION
|
0.68%
1/147 • Immediately after a participant was randomized within the trial and until 2 days following the last administration of study product (or the last study procedure) (approximately up to 86 days).
An AE was defined as any untoward medical occurrence in a study participant, temporally associated with the use of a study product whether or not considered related to the study product, including an acclimatization product (or medical device). A serious AE was a particular category of AE where the outcome was serious. Two participants in test group didn't take any study product as the treatment package was not delivered. Resulting 147 test and 150 Placebo participants in the Safety population.
|
0.00%
0/150 • Immediately after a participant was randomized within the trial and until 2 days following the last administration of study product (or the last study procedure) (approximately up to 86 days).
An AE was defined as any untoward medical occurrence in a study participant, temporally associated with the use of a study product whether or not considered related to the study product, including an acclimatization product (or medical device). A serious AE was a particular category of AE where the outcome was serious. Two participants in test group didn't take any study product as the treatment package was not delivered. Resulting 147 test and 150 Placebo participants in the Safety population.
|
|
Gastrointestinal disorders
FREQUENT BOWEL MOVEMENTS
|
0.00%
0/147 • Immediately after a participant was randomized within the trial and until 2 days following the last administration of study product (or the last study procedure) (approximately up to 86 days).
An AE was defined as any untoward medical occurrence in a study participant, temporally associated with the use of a study product whether or not considered related to the study product, including an acclimatization product (or medical device). A serious AE was a particular category of AE where the outcome was serious. Two participants in test group didn't take any study product as the treatment package was not delivered. Resulting 147 test and 150 Placebo participants in the Safety population.
|
0.67%
1/150 • Immediately after a participant was randomized within the trial and until 2 days following the last administration of study product (or the last study procedure) (approximately up to 86 days).
An AE was defined as any untoward medical occurrence in a study participant, temporally associated with the use of a study product whether or not considered related to the study product, including an acclimatization product (or medical device). A serious AE was a particular category of AE where the outcome was serious. Two participants in test group didn't take any study product as the treatment package was not delivered. Resulting 147 test and 150 Placebo participants in the Safety population.
|
|
Nervous system disorders
MIGRAINE
|
0.68%
1/147 • Immediately after a participant was randomized within the trial and until 2 days following the last administration of study product (or the last study procedure) (approximately up to 86 days).
An AE was defined as any untoward medical occurrence in a study participant, temporally associated with the use of a study product whether or not considered related to the study product, including an acclimatization product (or medical device). A serious AE was a particular category of AE where the outcome was serious. Two participants in test group didn't take any study product as the treatment package was not delivered. Resulting 147 test and 150 Placebo participants in the Safety population.
|
0.00%
0/150 • Immediately after a participant was randomized within the trial and until 2 days following the last administration of study product (or the last study procedure) (approximately up to 86 days).
An AE was defined as any untoward medical occurrence in a study participant, temporally associated with the use of a study product whether or not considered related to the study product, including an acclimatization product (or medical device). A serious AE was a particular category of AE where the outcome was serious. Two participants in test group didn't take any study product as the treatment package was not delivered. Resulting 147 test and 150 Placebo participants in the Safety population.
|
|
Nervous system disorders
PSYCHOMOTOR HYPERACTIVITY
|
0.00%
0/147 • Immediately after a participant was randomized within the trial and until 2 days following the last administration of study product (or the last study procedure) (approximately up to 86 days).
An AE was defined as any untoward medical occurrence in a study participant, temporally associated with the use of a study product whether or not considered related to the study product, including an acclimatization product (or medical device). A serious AE was a particular category of AE where the outcome was serious. Two participants in test group didn't take any study product as the treatment package was not delivered. Resulting 147 test and 150 Placebo participants in the Safety population.
|
0.67%
1/150 • Immediately after a participant was randomized within the trial and until 2 days following the last administration of study product (or the last study procedure) (approximately up to 86 days).
An AE was defined as any untoward medical occurrence in a study participant, temporally associated with the use of a study product whether or not considered related to the study product, including an acclimatization product (or medical device). A serious AE was a particular category of AE where the outcome was serious. Two participants in test group didn't take any study product as the treatment package was not delivered. Resulting 147 test and 150 Placebo participants in the Safety population.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
0.00%
0/147 • Immediately after a participant was randomized within the trial and until 2 days following the last administration of study product (or the last study procedure) (approximately up to 86 days).
An AE was defined as any untoward medical occurrence in a study participant, temporally associated with the use of a study product whether or not considered related to the study product, including an acclimatization product (or medical device). A serious AE was a particular category of AE where the outcome was serious. Two participants in test group didn't take any study product as the treatment package was not delivered. Resulting 147 test and 150 Placebo participants in the Safety population.
|
0.67%
1/150 • Immediately after a participant was randomized within the trial and until 2 days following the last administration of study product (or the last study procedure) (approximately up to 86 days).
An AE was defined as any untoward medical occurrence in a study participant, temporally associated with the use of a study product whether or not considered related to the study product, including an acclimatization product (or medical device). A serious AE was a particular category of AE where the outcome was serious. Two participants in test group didn't take any study product as the treatment package was not delivered. Resulting 147 test and 150 Placebo participants in the Safety population.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee HALEON agreements may vary with individual investigators but will not prohibit any investigator from publishing. HALEON supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER