Trial Outcomes & Findings for Study to Determine if a New Nicotine Replacement Therapy Can Safely Help Smokers to Quit Smoking (NCT NCT01296698)
NCT ID: NCT01296698
Last Updated: 2012-04-23
Results Overview
Number of participants with carbon monoxide (CO)-verified self-report of continuous abstinence from smoking from Week 2 through Week 6.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
257 participants
Primary outcome timeframe
through Week 6
Results posted on
2012-04-23
Participant Flow
Participant milestones
| Measure |
Placebo
0 mg Oral NRT, up to 4 times per hour for 12 weeks
|
Nicotine
1 mg Oral NRT, up to 4 times per hour for 12 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
244
|
13
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
244
|
13
|
Reasons for withdrawal
| Measure |
Placebo
0 mg Oral NRT, up to 4 times per hour for 12 weeks
|
Nicotine
1 mg Oral NRT, up to 4 times per hour for 12 weeks
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
19
|
1
|
|
Overall Study
Withdrawal by Subject
|
12
|
0
|
|
Overall Study
Difficulty Contacting Subject
|
2
|
0
|
|
Overall Study
Study Terminated by Sponsor
|
209
|
12
|
Baseline Characteristics
Study to Determine if a New Nicotine Replacement Therapy Can Safely Help Smokers to Quit Smoking
Baseline characteristics by cohort
| Measure |
Placebo
n=244 Participants
0 mg Oral NRT, up to 4 times per hour for 12 weeks
|
Nicotine
n=13 Participants
1 mg Oral NRT, up to 4 times per hour for 12 weeks
|
Total
n=257 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
47.1 years
STANDARD_DEVIATION 14.0 • n=39 Participants
|
49.9 years
STANDARD_DEVIATION 11.4 • n=41 Participants
|
47.2 years
STANDARD_DEVIATION 13.9 • n=35 Participants
|
|
Sex: Female, Male
Female
|
131 Participants
n=39 Participants
|
8 Participants
n=41 Participants
|
139 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
113 Participants
n=39 Participants
|
5 Participants
n=41 Participants
|
118 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
244 participants
n=39 Participants
|
13 participants
n=41 Participants
|
257 participants
n=35 Participants
|
PRIMARY outcome
Timeframe: through Week 6Population: The study was terminated prematurely due to a technical issue (randomization error) and no data are available.
Number of participants with carbon monoxide (CO)-verified self-report of continuous abstinence from smoking from Week 2 through Week 6.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: through Week 26Population: The study was terminated prematurely due to a technical issue (randomization error) and no data are available.
Number of participants with carbon monoxide (CO)-verified self report of continuous abstinence from smoking from Week 2 to Weeks 4, 6, 12, 16, and 26.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: through Week 26Population: The study was terminated prematurely due to a technical issue (randomization error).
Number of participants with carbon monoxide (CO)-verified self-reported 7-day point prevalence abstinence from smoking at Weeks 2, 4, 6, 12, 16, and 26.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 1Population: Analysis was limited to data collected from participants at Week 1.
Mean number of daily doses by study week.
Outcome measures
| Measure |
Placebo
n=142 Participants
0 mg Oral NRT, up to 4 times per hour for 12 weeks
|
Nicotine
n=6 Participants
1 mg Oral NRT, up to 4 times per hour for 12 weeks
|
|---|---|---|
|
Mean Number of Daily Doses
|
16.7 Daily Doses
Standard Deviation 11.7
|
14.9 Daily Doses
Standard Deviation 7.3
|
SECONDARY outcome
Timeframe: Week 2Population: Analysis was limited to data collected from participants at Week 2.
Mean number of daily doses by study week.
Outcome measures
| Measure |
Placebo
n=124 Participants
0 mg Oral NRT, up to 4 times per hour for 12 weeks
|
Nicotine
n=7 Participants
1 mg Oral NRT, up to 4 times per hour for 12 weeks
|
|---|---|---|
|
Mean Number of Daily Doses
|
15.8 Daily Doses
Standard Deviation 11.4
|
18.0 Daily Doses
Standard Deviation 14.2
|
SECONDARY outcome
Timeframe: Week 3Population: Analysis was limited to data collected from participants at Week 3.
Mean number of daily doses by study week.
Outcome measures
| Measure |
Placebo
n=76 Participants
0 mg Oral NRT, up to 4 times per hour for 12 weeks
|
Nicotine
n=5 Participants
1 mg Oral NRT, up to 4 times per hour for 12 weeks
|
|---|---|---|
|
Mean Number of Daily Doses
|
13.1 Daily Doses
Standard Deviation 9.4
|
15.8 Daily Doses
Standard Deviation 9.2
|
SECONDARY outcome
Timeframe: Week 4Population: Analysis was limited to data collected from participants at Week 4.
Mean number of daily doses by study week.
Outcome measures
| Measure |
Placebo
n=44 Participants
0 mg Oral NRT, up to 4 times per hour for 12 weeks
|
Nicotine
n=3 Participants
1 mg Oral NRT, up to 4 times per hour for 12 weeks
|
|---|---|---|
|
Mean Number of Daily Doses
|
12.2 Daily Doses
Standard Deviation 10.8
|
10.5 Daily Doses
Standard Deviation 5.7
|
SECONDARY outcome
Timeframe: Week 5Population: Analysis was limited to data collected from participants at Week 5.
Mean number of daily doses by study week.
Outcome measures
| Measure |
Placebo
n=21 Participants
0 mg Oral NRT, up to 4 times per hour for 12 weeks
|
Nicotine
n=1 Participants
1 mg Oral NRT, up to 4 times per hour for 12 weeks
|
|---|---|---|
|
Mean Number of Daily Doses
|
10.9 Daily Doses
Standard Deviation 11.3
|
4.0 Daily Doses
Standard Deviation 0.0
|
SECONDARY outcome
Timeframe: Week 6Population: Analysis was limited to data collected from participants at Week 6. Analysis of data for the remainder of the study weeks was not possible because the trial terminated prematurely due to a technical issue (randomization error).
Mean number of daily doses by study week.
Outcome measures
| Measure |
Placebo
n=5 Participants
0 mg Oral NRT, up to 4 times per hour for 12 weeks
|
Nicotine
1 mg Oral NRT, up to 4 times per hour for 12 weeks
|
|---|---|---|
|
Mean Number of Daily Doses
|
13.3 Daily Doses
Standard Deviation 12.8
|
—
|
SECONDARY outcome
Timeframe: within 12 WeeksPopulation: Analysis was limited to data collected from participants who had used study medication at least one day.
Percentage of participants who used more than 64 doses in any one-day period.
Outcome measures
| Measure |
Placebo
n=149 Participants
0 mg Oral NRT, up to 4 times per hour for 12 weeks
|
Nicotine
n=8 Participants
1 mg Oral NRT, up to 4 times per hour for 12 weeks
|
|---|---|---|
|
Percentage of Participants With High Dosage
|
2.0 Percentage of Participants
|
0 Percentage of Participants
|
SECONDARY outcome
Timeframe: within 12 WeeksPopulation: Analysis was limited to data collected from participants who had used study medication at least one day.
Percentage of participants who used more than four doses in any one-hour period.
Outcome measures
| Measure |
Placebo
n=149 Participants
0 mg Oral NRT, up to 4 times per hour for 12 weeks
|
Nicotine
n=8 Participants
1 mg Oral NRT, up to 4 times per hour for 12 weeks
|
|---|---|---|
|
Percentage of Participants With High Usage
|
28.2 Percentage of Participants
|
25 Percentage of Participants
|
SECONDARY outcome
Timeframe: within 12 WeeksPopulation: Analysis was limited to participants who used study medication at least once and who completed the questionnaire.
Participants are asked if during the last 24 hours they experienced the Desire/Urge to Smoke on a 5-grade categorical scale from Not at all to Extremely so.
Outcome measures
| Measure |
Placebo
n=92 Participants
0 mg Oral NRT, up to 4 times per hour for 12 weeks
|
Nicotine
n=2 Participants
1 mg Oral NRT, up to 4 times per hour for 12 weeks
|
|---|---|---|
|
Highest Rating of Desire/Urge to Smoke on a Categorical Scale
Not at all
|
2.2 Percentage of Participants
|
0 Percentage of Participants
|
|
Highest Rating of Desire/Urge to Smoke on a Categorical Scale
Somewhat
|
30.4 Percentage of Participants
|
100 Percentage of Participants
|
|
Highest Rating of Desire/Urge to Smoke on a Categorical Scale
Moderately so
|
33.7 Percentage of Participants
|
0 Percentage of Participants
|
|
Highest Rating of Desire/Urge to Smoke on a Categorical Scale
Very much so
|
22.8 Percentage of Participants
|
0 Percentage of Participants
|
|
Highest Rating of Desire/Urge to Smoke on a Categorical Scale
Extremely so
|
10.9 Percentage of Participants
|
0 Percentage of Participants
|
SECONDARY outcome
Timeframe: within 12 WeeksPopulation: Analysis was limited to participants who used study medication at least once and who completed the questionnaire.
Participants are asked if during the last 24 hours they experienced Irritability/Frustration/Anger on a 5-grade categorical scale from Not at all to Extremely so.
Outcome measures
| Measure |
Placebo
n=92 Participants
0 mg Oral NRT, up to 4 times per hour for 12 weeks
|
Nicotine
n=2 Participants
1 mg Oral NRT, up to 4 times per hour for 12 weeks
|
|---|---|---|
|
Highest Rating of Irritability/Frustration/Anger on a Categorical Scale
Not at all
|
30.4 Percentage of Participants
|
50.0 Percentage of Participants
|
|
Highest Rating of Irritability/Frustration/Anger on a Categorical Scale
Somewhat
|
27.2 Percentage of Participants
|
50.0 Percentage of Participants
|
|
Highest Rating of Irritability/Frustration/Anger on a Categorical Scale
Moderately so
|
23.9 Percentage of Participants
|
0 Percentage of Participants
|
|
Highest Rating of Irritability/Frustration/Anger on a Categorical Scale
Very much so
|
15.2 Percentage of Participants
|
0 Percentage of Participants
|
|
Highest Rating of Irritability/Frustration/Anger on a Categorical Scale
Extremely so
|
3.3 Percentage of Participants
|
0 Percentage of Participants
|
SECONDARY outcome
Timeframe: within 12 WeeksPopulation: Analysis was limited to participants who used study medication at least once and who completed the questionnaire.
Participants are asked if during the last 24 hours they experienced Restlessness on a 5-grade categorical scale from Not at all to Extremely so.
Outcome measures
| Measure |
Placebo
n=92 Participants
0 mg Oral NRT, up to 4 times per hour for 12 weeks
|
Nicotine
n=2 Participants
1 mg Oral NRT, up to 4 times per hour for 12 weeks
|
|---|---|---|
|
Highest Rating of Restlessness on a Categorical Scale
Not at all
|
43.5 Percentage of Participants
|
0 Percentage of Participants
|
|
Highest Rating of Restlessness on a Categorical Scale
Somewhat
|
25.0 Percentage of Participants
|
100 Percentage of Participants
|
|
Highest Rating of Restlessness on a Categorical Scale
Moderately so
|
12.0 Percentage of Participants
|
0 Percentage of Participants
|
|
Highest Rating of Restlessness on a Categorical Scale
Very much so
|
13.0 Percentage of Participants
|
0 Percentage of Participants
|
|
Highest Rating of Restlessness on a Categorical Scale
Extremely so
|
6.5 Percentage of Participants
|
0 Percentage of Participants
|
SECONDARY outcome
Timeframe: within 12 WeeksPopulation: Analysis was limited to participants who used study medication at least once and completed the questionnaire.
Participants are asked if during the last 24 hours they experienced Difficulty Concentrating on a 5-grade categorical scale from Not at all to Extremely so.
Outcome measures
| Measure |
Placebo
n=92 Participants
0 mg Oral NRT, up to 4 times per hour for 12 weeks
|
Nicotine
n=2 Participants
1 mg Oral NRT, up to 4 times per hour for 12 weeks
|
|---|---|---|
|
Highest Rating of Difficulty Concentrating on a Categorical Scale
Not at all
|
53.3 Percentage of Participants
|
50.0 Percentage of Participants
|
|
Highest Rating of Difficulty Concentrating on a Categorical Scale
Somewhat
|
18.5 Percentage of Participants
|
50.0 Percentage of Participants
|
|
Highest Rating of Difficulty Concentrating on a Categorical Scale
Moderately so
|
15.2 Percentage of Participants
|
0 Percentage of Participants
|
|
Highest Rating of Difficulty Concentrating on a Categorical Scale
Very much so
|
9.8 Percentage of Participants
|
0 Percentage of Participants
|
|
Highest Rating of Difficulty Concentrating on a Categorical Scale
Extremely so
|
3.3 Percentage of Participants
|
0 Percentage of Participants
|
SECONDARY outcome
Timeframe: within 12 WeeksPopulation: Analysis was limited to participants who used study medication at least once and who completed the questionnaire.
Participants are asked if during the last 24 hours they experienced Anxiety on a 5-grade categorical scale from Not at all to Extremely so.
Outcome measures
| Measure |
Placebo
n=92 Participants
0 mg Oral NRT, up to 4 times per hour for 12 weeks
|
Nicotine
n=2 Participants
1 mg Oral NRT, up to 4 times per hour for 12 weeks
|
|---|---|---|
|
Highest Rating of Anxiety on a Categorical Scale
Not at all
|
44.6 Percentage of Participants
|
50.0 Percentage of Participants
|
|
Highest Rating of Anxiety on a Categorical Scale
Somewhat
|
23.9 Percentage of Participants
|
0 Percentage of Participants
|
|
Highest Rating of Anxiety on a Categorical Scale
Moderately so
|
15.2 Percentage of Participants
|
0 Percentage of Participants
|
|
Highest Rating of Anxiety on a Categorical Scale
Very much so
|
13.0 Percentage of Participants
|
50.0 Percentage of Participants
|
|
Highest Rating of Anxiety on a Categorical Scale
Extremely so
|
3.3 Percentage of Participants
|
0 Percentage of Participants
|
SECONDARY outcome
Timeframe: within 12 WeeksPopulation: Analysis was limited to participants who used study medication at least once and who completed the questionnaire.
Participants are asked if during the last 24 hours they experienced Dysphoric or Depressed Mood on a 5-grade categorical scale from Not at all to Extremely so.
Outcome measures
| Measure |
Placebo
n=92 Participants
0 mg Oral NRT, up to 4 times per hour for 12 weeks
|
Nicotine
n=2 Participants
1 mg Oral NRT, up to 4 times per hour for 12 weeks
|
|---|---|---|
|
Highest Rating of Dysphoric or Depressed Mood on a Categorical Scale
Not at all
|
66.3 Percentage of Participants
|
0 Percentage of Participants
|
|
Highest Rating of Dysphoric or Depressed Mood on a Categorical Scale
Somewhat
|
19.6 Percentage of Participants
|
100 Percentage of Participants
|
|
Highest Rating of Dysphoric or Depressed Mood on a Categorical Scale
Moderately so
|
9.8 Percentage of Participants
|
0 Percentage of Participants
|
|
Highest Rating of Dysphoric or Depressed Mood on a Categorical Scale
Very much so
|
3.3 Percentage of Participants
|
0 Percentage of Participants
|
|
Highest Rating of Dysphoric or Depressed Mood on a Categorical Scale
Extremely so
|
1.1 Percentage of Participants
|
0 Percentage of Participants
|
SECONDARY outcome
Timeframe: within 12 WeeksPopulation: Analysis was limited to participants who used study medication at least once and who completed the questionnaire.
Participants are asked if during the last 24 hours they experienced Insomnia on a 5-grade categorical scale from Not at all to Extremely so.
Outcome measures
| Measure |
Placebo
n=92 Participants
0 mg Oral NRT, up to 4 times per hour for 12 weeks
|
Nicotine
n=2 Participants
1 mg Oral NRT, up to 4 times per hour for 12 weeks
|
|---|---|---|
|
Highest Rating of Insomnia on a Categorical Scale
Not at all
|
56.5 Percentage of Participants
|
50.0 Percentage of Participants
|
|
Highest Rating of Insomnia on a Categorical Scale
Somewhat
|
22.8 Percentage of Participants
|
0 Percentage of Participants
|
|
Highest Rating of Insomnia on a Categorical Scale
Moderately so
|
10.9 Percentage of Participants
|
50.0 Percentage of Participants
|
|
Highest Rating of Insomnia on a Categorical Scale
Very much so
|
3.3 Percentage of Participants
|
0 Percentage of Participants
|
|
Highest Rating of Insomnia on a Categorical Scale
Extremely so
|
6.5 Percentage of Participants
|
0 Percentage of Participants
|
SECONDARY outcome
Timeframe: within 12 WeeksPopulation: Analysis was limited to participants who used study medication at least once and who completed the questionnaire.
Participants are asked if during the last 24 hours they experienced Increased Appetite on a 5-grade categorical scale from Not at all to Extremely so.
Outcome measures
| Measure |
Placebo
n=92 Participants
0 mg Oral NRT, up to 4 times per hour for 12 weeks
|
Nicotine
n=2 Participants
1 mg Oral NRT, up to 4 times per hour for 12 weeks
|
|---|---|---|
|
Highest Rating of Increased Appetite on a Categorical Scale
Not at all
|
54.3 Percentage of Participants
|
0 Percentage of Participants
|
|
Highest Rating of Increased Appetite on a Categorical Scale
Somewhat
|
13.0 Percentage of Participants
|
100 Percentage of Participants
|
|
Highest Rating of Increased Appetite on a Categorical Scale
Moderately so
|
15.2 Percentage of Participants
|
0 Percentage of Participants
|
|
Highest Rating of Increased Appetite on a Categorical Scale
Very much so
|
15.2 Percentage of Participants
|
0 Percentage of Participants
|
|
Highest Rating of Increased Appetite on a Categorical Scale
Extremely so
|
2.2 Percentage of Participants
|
0 Percentage of Participants
|
SECONDARY outcome
Timeframe: through Week 12Population: The study was terminated prematurely due to a technical issue (randomization error) and no data are available.
Participants are asked to rate their general perception of the investigational product on a scale of 1-10, where 1=very poor and 10=excellent.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: through 12 WeeksPopulation: The study was terminated prematurely due to a technical issue (randomization error) and no data are available.
Participants are asked to rate the product in its effectiveness for dealing with cravings, on a scale of 1-5, where 1=not at all effective, and 5=extremely effective.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: through 12 WeeksPopulation: The study was terminated prematurely due to a technical issue (randomization error) and no data are available.
Participants are asked to rate the product for speed of action, on a scale of 1-9, where 1=extremely slow and 9=extremely fast.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: through 12 WeeksPopulation: The study was terminated prematurely due to a technical issue (randomization error) and no data are available.
Participants are asked to rate how their opinion has changed since the first time they used it, on a score of 1-5, where 1=I like it much less now and 5=I like it much more now.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: through 12 WeeksPopulation: The study was terminated prematurely due to a technical issue (randomization error) and no data are available.
Participants are asked to rate how convenient the product is to use, on a scale of 1-5, where 1=not at all convenient and 5=extremely convenient.
Outcome measures
Outcome data not reported
Adverse Events
Placebo
Serious events: 4 serious events
Other events: 33 other events
Deaths: 0 deaths
Nicotine
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=242 participants at risk
0 mg Oral NRT, up to 4 times per hour for 12 weeks
|
Nicotine
n=13 participants at risk
1 mg Oral NRT, up to 4 times per hour for 12 weeks
|
|---|---|---|
|
Cardiac disorders
Cardiac Failure Congestive
|
0.00%
0/242 • Adverse events were collected during study and during telephone interview after study termination. Serious adverse events and adverse events categorized as probably or very likely related to study product were followed until they resolved or stabilized.
Two subjects who did not receive study medication were excluded from the safety analysis set as defined in the Statistical Analysis Plan.
|
7.7%
1/13 • Adverse events were collected during study and during telephone interview after study termination. Serious adverse events and adverse events categorized as probably or very likely related to study product were followed until they resolved or stabilized.
Two subjects who did not receive study medication were excluded from the safety analysis set as defined in the Statistical Analysis Plan.
|
|
General disorders
Death
|
0.41%
1/242 • Adverse events were collected during study and during telephone interview after study termination. Serious adverse events and adverse events categorized as probably or very likely related to study product were followed until they resolved or stabilized.
Two subjects who did not receive study medication were excluded from the safety analysis set as defined in the Statistical Analysis Plan.
|
0.00%
0/13 • Adverse events were collected during study and during telephone interview after study termination. Serious adverse events and adverse events categorized as probably or very likely related to study product were followed until they resolved or stabilized.
Two subjects who did not receive study medication were excluded from the safety analysis set as defined in the Statistical Analysis Plan.
|
|
General disorders
Device Malfunction
|
0.41%
1/242 • Adverse events were collected during study and during telephone interview after study termination. Serious adverse events and adverse events categorized as probably or very likely related to study product were followed until they resolved or stabilized.
Two subjects who did not receive study medication were excluded from the safety analysis set as defined in the Statistical Analysis Plan.
|
0.00%
0/13 • Adverse events were collected during study and during telephone interview after study termination. Serious adverse events and adverse events categorized as probably or very likely related to study product were followed until they resolved or stabilized.
Two subjects who did not receive study medication were excluded from the safety analysis set as defined in the Statistical Analysis Plan.
|
|
General disorders
Fatigue
|
0.41%
1/242 • Adverse events were collected during study and during telephone interview after study termination. Serious adverse events and adverse events categorized as probably or very likely related to study product were followed until they resolved or stabilized.
Two subjects who did not receive study medication were excluded from the safety analysis set as defined in the Statistical Analysis Plan.
|
0.00%
0/13 • Adverse events were collected during study and during telephone interview after study termination. Serious adverse events and adverse events categorized as probably or very likely related to study product were followed until they resolved or stabilized.
Two subjects who did not receive study medication were excluded from the safety analysis set as defined in the Statistical Analysis Plan.
|
|
Nervous system disorders
Loss of Consciousness
|
0.41%
1/242 • Adverse events were collected during study and during telephone interview after study termination. Serious adverse events and adverse events categorized as probably or very likely related to study product were followed until they resolved or stabilized.
Two subjects who did not receive study medication were excluded from the safety analysis set as defined in the Statistical Analysis Plan.
|
0.00%
0/13 • Adverse events were collected during study and during telephone interview after study termination. Serious adverse events and adverse events categorized as probably or very likely related to study product were followed until they resolved or stabilized.
Two subjects who did not receive study medication were excluded from the safety analysis set as defined in the Statistical Analysis Plan.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.41%
1/242 • Adverse events were collected during study and during telephone interview after study termination. Serious adverse events and adverse events categorized as probably or very likely related to study product were followed until they resolved or stabilized.
Two subjects who did not receive study medication were excluded from the safety analysis set as defined in the Statistical Analysis Plan.
|
0.00%
0/13 • Adverse events were collected during study and during telephone interview after study termination. Serious adverse events and adverse events categorized as probably or very likely related to study product were followed until they resolved or stabilized.
Two subjects who did not receive study medication were excluded from the safety analysis set as defined in the Statistical Analysis Plan.
|
Other adverse events
| Measure |
Placebo
n=242 participants at risk
0 mg Oral NRT, up to 4 times per hour for 12 weeks
|
Nicotine
n=13 participants at risk
1 mg Oral NRT, up to 4 times per hour for 12 weeks
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
1.2%
3/242 • Adverse events were collected during study and during telephone interview after study termination. Serious adverse events and adverse events categorized as probably or very likely related to study product were followed until they resolved or stabilized.
Two subjects who did not receive study medication were excluded from the safety analysis set as defined in the Statistical Analysis Plan.
|
7.7%
1/13 • Adverse events were collected during study and during telephone interview after study termination. Serious adverse events and adverse events categorized as probably or very likely related to study product were followed until they resolved or stabilized.
Two subjects who did not receive study medication were excluded from the safety analysis set as defined in the Statistical Analysis Plan.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/242 • Adverse events were collected during study and during telephone interview after study termination. Serious adverse events and adverse events categorized as probably or very likely related to study product were followed until they resolved or stabilized.
Two subjects who did not receive study medication were excluded from the safety analysis set as defined in the Statistical Analysis Plan.
|
7.7%
1/13 • Adverse events were collected during study and during telephone interview after study termination. Serious adverse events and adverse events categorized as probably or very likely related to study product were followed until they resolved or stabilized.
Two subjects who did not receive study medication were excluded from the safety analysis set as defined in the Statistical Analysis Plan.
|
|
Gastrointestinal disorders
Gingival Pain
|
0.41%
1/242 • Adverse events were collected during study and during telephone interview after study termination. Serious adverse events and adverse events categorized as probably or very likely related to study product were followed until they resolved or stabilized.
Two subjects who did not receive study medication were excluded from the safety analysis set as defined in the Statistical Analysis Plan.
|
7.7%
1/13 • Adverse events were collected during study and during telephone interview after study termination. Serious adverse events and adverse events categorized as probably or very likely related to study product were followed until they resolved or stabilized.
Two subjects who did not receive study medication were excluded from the safety analysis set as defined in the Statistical Analysis Plan.
|
|
Gastrointestinal disorders
Oral Pain
|
1.7%
4/242 • Adverse events were collected during study and during telephone interview after study termination. Serious adverse events and adverse events categorized as probably or very likely related to study product were followed until they resolved or stabilized.
Two subjects who did not receive study medication were excluded from the safety analysis set as defined in the Statistical Analysis Plan.
|
7.7%
1/13 • Adverse events were collected during study and during telephone interview after study termination. Serious adverse events and adverse events categorized as probably or very likely related to study product were followed until they resolved or stabilized.
Two subjects who did not receive study medication were excluded from the safety analysis set as defined in the Statistical Analysis Plan.
|
|
Gastrointestinal disorders
Sensitivity of Teeth
|
0.00%
0/242 • Adverse events were collected during study and during telephone interview after study termination. Serious adverse events and adverse events categorized as probably or very likely related to study product were followed until they resolved or stabilized.
Two subjects who did not receive study medication were excluded from the safety analysis set as defined in the Statistical Analysis Plan.
|
7.7%
1/13 • Adverse events were collected during study and during telephone interview after study termination. Serious adverse events and adverse events categorized as probably or very likely related to study product were followed until they resolved or stabilized.
Two subjects who did not receive study medication were excluded from the safety analysis set as defined in the Statistical Analysis Plan.
|
|
Gastrointestinal disorders
Vomiting
|
1.2%
3/242 • Adverse events were collected during study and during telephone interview after study termination. Serious adverse events and adverse events categorized as probably or very likely related to study product were followed until they resolved or stabilized.
Two subjects who did not receive study medication were excluded from the safety analysis set as defined in the Statistical Analysis Plan.
|
7.7%
1/13 • Adverse events were collected during study and during telephone interview after study termination. Serious adverse events and adverse events categorized as probably or very likely related to study product were followed until they resolved or stabilized.
Two subjects who did not receive study medication were excluded from the safety analysis set as defined in the Statistical Analysis Plan.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
0.00%
0/242 • Adverse events were collected during study and during telephone interview after study termination. Serious adverse events and adverse events categorized as probably or very likely related to study product were followed until they resolved or stabilized.
Two subjects who did not receive study medication were excluded from the safety analysis set as defined in the Statistical Analysis Plan.
|
7.7%
1/13 • Adverse events were collected during study and during telephone interview after study termination. Serious adverse events and adverse events categorized as probably or very likely related to study product were followed until they resolved or stabilized.
Two subjects who did not receive study medication were excluded from the safety analysis set as defined in the Statistical Analysis Plan.
|
|
Nervous system disorders
Headache
|
8.3%
20/242 • Adverse events were collected during study and during telephone interview after study termination. Serious adverse events and adverse events categorized as probably or very likely related to study product were followed until they resolved or stabilized.
Two subjects who did not receive study medication were excluded from the safety analysis set as defined in the Statistical Analysis Plan.
|
0.00%
0/13 • Adverse events were collected during study and during telephone interview after study termination. Serious adverse events and adverse events categorized as probably or very likely related to study product were followed until they resolved or stabilized.
Two subjects who did not receive study medication were excluded from the safety analysis set as defined in the Statistical Analysis Plan.
|
|
Nervous system disorders
Migraine
|
1.2%
3/242 • Adverse events were collected during study and during telephone interview after study termination. Serious adverse events and adverse events categorized as probably or very likely related to study product were followed until they resolved or stabilized.
Two subjects who did not receive study medication were excluded from the safety analysis set as defined in the Statistical Analysis Plan.
|
7.7%
1/13 • Adverse events were collected during study and during telephone interview after study termination. Serious adverse events and adverse events categorized as probably or very likely related to study product were followed until they resolved or stabilized.
Two subjects who did not receive study medication were excluded from the safety analysis set as defined in the Statistical Analysis Plan.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/242 • Adverse events were collected during study and during telephone interview after study termination. Serious adverse events and adverse events categorized as probably or very likely related to study product were followed until they resolved or stabilized.
Two subjects who did not receive study medication were excluded from the safety analysis set as defined in the Statistical Analysis Plan.
|
38.5%
5/13 • Adverse events were collected during study and during telephone interview after study termination. Serious adverse events and adverse events categorized as probably or very likely related to study product were followed until they resolved or stabilized.
Two subjects who did not receive study medication were excluded from the safety analysis set as defined in the Statistical Analysis Plan.
|
Additional Information
Joyce Hauze, RPS Sr. Specialist, Clinical Research Operations
Johnson & Johnson Consumer and Personal Products Worldwide
Phone: 928-277-0715
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Principal Investigators agreed not to discuss or publish the details/results of this study.
- Publication restrictions are in place
Restriction type: OTHER