Trial Outcomes & Findings for Safety and Efficacy of Generic Diclofenac Epolamine Acute Pain Due to Minor Ankle Sprain (NCT NCT02324270)
NCT ID: NCT02324270
Last Updated: 2020-06-24
Results Overview
To evaluate the therapeutic equivalence (90% CI) of generic diclofenac epolamine 1.3% patch (Watson Laboratories, Inc.) and Flector® (diclofenac epolamine 1.3% patch) (Pfizer) using a 100mm VAS scoring in the treatment of acute pain due to minor ankle sprain (in the per protocol population); changes from baseline. The Visual Analogue Scale (VAS) consists of a straight line with the endpoints defining extreme limits such as lower values of 'no pain at all' and higher values relating to 'pain as bad as it could be' . Percent improvement in VAS score is the percentage part of - change from baseline in VAS / Baseline VAS.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
658 participants
Primary outcome timeframe
Baseline, 3 days
Results posted on
2020-06-24
Participant Flow
The populations for this study included the Safety Population, the Per-Protocol Population (PP) and the modified Intent-to-treat (mITT) population.
Participant milestones
| Measure |
Diclofenac Epolamine Patch (Test Product)
Generic Diclofenac Epolamine Topical Patch 1.3% (Watson Laboratories, Inc.)
Diclofenac epolamine: Diclofenac epolamine in a topical patch formulation; applied to the area of sprained ankle; to treat pain associated with a mild ankle sprain
|
Flector (Reference Product)
Flector® (Diclofenac Epolamine Topical Patch 1.3%) (Pfizer)
Diclofenac epolamine: Diclofenac epolamine in a topical patch formulation; applied to the area of sprained ankle; to treat pain associated with a mild ankle sprain
|
Placebo
Placebo patch of the test product (Watson Laboratories, Inc.); Identical in appearance and formulated as the test product, omitting the active ingredient, diclofenac epolamine
Placebo: Topical patch not containing diclofenac epolamine applied to the area of sprained ankle; to treat pain associated with a mild ankle sprain
|
|---|---|---|---|
|
Overall Study
STARTED
|
218
|
219
|
221
|
|
Overall Study
Safety Population
|
214
|
216
|
217
|
|
Overall Study
mITT Population
|
214
|
216
|
217
|
|
Overall Study
PP Population
|
180
|
177
|
171
|
|
Overall Study
COMPLETED
|
213
|
212
|
216
|
|
Overall Study
NOT COMPLETED
|
5
|
7
|
5
|
Reasons for withdrawal
| Measure |
Diclofenac Epolamine Patch (Test Product)
Generic Diclofenac Epolamine Topical Patch 1.3% (Watson Laboratories, Inc.)
Diclofenac epolamine: Diclofenac epolamine in a topical patch formulation; applied to the area of sprained ankle; to treat pain associated with a mild ankle sprain
|
Flector (Reference Product)
Flector® (Diclofenac Epolamine Topical Patch 1.3%) (Pfizer)
Diclofenac epolamine: Diclofenac epolamine in a topical patch formulation; applied to the area of sprained ankle; to treat pain associated with a mild ankle sprain
|
Placebo
Placebo patch of the test product (Watson Laboratories, Inc.); Identical in appearance and formulated as the test product, omitting the active ingredient, diclofenac epolamine
Placebo: Topical patch not containing diclofenac epolamine applied to the area of sprained ankle; to treat pain associated with a mild ankle sprain
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
4
|
3
|
4
|
|
Overall Study
Protocol Violation
|
0
|
1
|
1
|
|
Overall Study
Non Compliance with Study Drug
|
1
|
2
|
0
|
Baseline Characteristics
Safety and Efficacy of Generic Diclofenac Epolamine Acute Pain Due to Minor Ankle Sprain
Baseline characteristics by cohort
| Measure |
Diclofenac Epolamine Patch (Test Product)
n=214 Participants
Generic Diclofenac Epolamine Topical Patch 1.3% (Watson Laboratories, Inc.)
Diclofenac epolamine: Diclofenac epolamine in a topical patch formulation; applied to the area of sprained ankle; to treat pain associated with a mild ankle sprain
|
Flector (Reference Product)
n=216 Participants
Flector® (Diclofenac Epolamine Topical Patch 1.3%) (Pfizer)
Diclofenac epolamine: Diclofenac epolamine in a topical patch formulation; applied to the area of sprained ankle; to treat pain associated with a mild ankle sprain
|
Placebo
n=217 Participants
Placebo patch of the test product (Watson Laboratories, Inc.); Identical in appearance and formulated as the test product, omitting the active ingredient, diclofenac epolamine
Placebo: Topical patch not containing diclofenac epolamine applied to the area of sprained ankle; to treat pain associated with a mild ankle sprain
|
Total
n=647 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
34.7 years
STANDARD_DEVIATION 12.1 • n=99 Participants
|
34.9 years
STANDARD_DEVIATION 12.5 • n=107 Participants
|
35.5 years
STANDARD_DEVIATION 13.3 • n=206 Participants
|
35.0 years
STANDARD_DEVIATION 12.6 • n=7 Participants
|
|
Sex: Female, Male
Female
|
85 Participants
n=99 Participants
|
79 Participants
n=107 Participants
|
82 Participants
n=206 Participants
|
246 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
129 Participants
n=99 Participants
|
137 Participants
n=107 Participants
|
135 Participants
n=206 Participants
|
401 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
86 Participants
n=99 Participants
|
78 Participants
n=107 Participants
|
83 Participants
n=206 Participants
|
247 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
128 Participants
n=99 Participants
|
138 Participants
n=107 Participants
|
134 Participants
n=206 Participants
|
400 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
11 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
60 Participants
n=99 Participants
|
59 Participants
n=107 Participants
|
71 Participants
n=206 Participants
|
190 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
147 Participants
n=99 Participants
|
149 Participants
n=107 Participants
|
140 Participants
n=206 Participants
|
436 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
214 participants
n=99 Participants
|
216 participants
n=107 Participants
|
217 participants
n=206 Participants
|
647 participants
n=7 Participants
|
|
Height (cm)
|
171.44 cm
STANDARD_DEVIATION 10.74 • n=99 Participants
|
173.28 cm
STANDARD_DEVIATION 10.80 • n=107 Participants
|
172.17 cm
STANDARD_DEVIATION 9.72 • n=206 Participants
|
172.30 cm
STANDARD_DEVIATION 10.44 • n=7 Participants
|
|
Weight (kg)
|
81.73 Kg
STANDARD_DEVIATION 19.86 • n=99 Participants
|
83.34 Kg
STANDARD_DEVIATION 17.11 • n=107 Participants
|
83.97 Kg
STANDARD_DEVIATION 20.10 • n=206 Participants
|
83.02 Kg
STANDARD_DEVIATION 19.07 • n=7 Participants
|
PRIMARY outcome
Timeframe: Baseline, 3 daysPopulation: Per Protocol Population
To evaluate the therapeutic equivalence (90% CI) of generic diclofenac epolamine 1.3% patch (Watson Laboratories, Inc.) and Flector® (diclofenac epolamine 1.3% patch) (Pfizer) using a 100mm VAS scoring in the treatment of acute pain due to minor ankle sprain (in the per protocol population); changes from baseline. The Visual Analogue Scale (VAS) consists of a straight line with the endpoints defining extreme limits such as lower values of 'no pain at all' and higher values relating to 'pain as bad as it could be' . Percent improvement in VAS score is the percentage part of - change from baseline in VAS / Baseline VAS.
Outcome measures
| Measure |
Diclofenac Epolamine Patch (Test Product)
n=180 Participants
Generic Diclofenac Epolamine Topical Patch 1.3% (Watson Laboratories, Inc.)
Diclofenac epolamine: Diclofenac epolamine in a topical patch formulation; applied to the area of sprained ankle; to treat pain associated with a mild ankle sprain
|
Flector (Reference Product)
n=177 Participants
Flector® (Diclofenac Epolamine Topical Patch 1.3%) (Pfizer)
Diclofenac epolamine: Diclofenac epolamine in a topical patch formulation; applied to the area of sprained ankle; to treat pain associated with a mild ankle sprain
|
Placebo
Placebo patch of the test product (Watson Laboratories, Inc.); Identical in appearance and formulated as the test product, omitting the active ingredient, diclofenac epolamine
Placebo: Topical patch not containing diclofenac epolamine applied to the area of sprained ankle; to treat pain associated with a mild ankle sprain
|
|---|---|---|---|
|
Visual Analogue Scale (VAS) Scores at Baseline and Post Treatment
Baseline
|
68.56 score on a scale
Standard Deviation 11.03
|
69.03 score on a scale
Standard Deviation 10.90
|
—
|
|
Visual Analogue Scale (VAS) Scores at Baseline and Post Treatment
72 Hours after Initial treatment
|
25.34 score on a scale
Standard Deviation 17.35
|
25.78 score on a scale
Standard Deviation 18.50
|
—
|
|
Visual Analogue Scale (VAS) Scores at Baseline and Post Treatment
Change from Baseline
|
-43.22 score on a scale
Standard Deviation 18.94
|
-43.25 score on a scale
Standard Deviation 20.71
|
—
|
SECONDARY outcome
Timeframe: Baseline, 3 daysPopulation: Modified Intent-to-Treat Population
To demonstrate the superiority (P\<0.05) of the efficacy of the test and reference products over that of the vehicle control in the treatment of acute pain utilizing a 100 mm VAS (in the mITT population) - changes from baseline. The Visual Analogue Scale (VAS) consists of a straight line with the endpoints defining extreme limits such as lower values of 'no pain at all' and higher values relating to 'pain as bad as it could be' .
Outcome measures
| Measure |
Diclofenac Epolamine Patch (Test Product)
n=214 Participants
Generic Diclofenac Epolamine Topical Patch 1.3% (Watson Laboratories, Inc.)
Diclofenac epolamine: Diclofenac epolamine in a topical patch formulation; applied to the area of sprained ankle; to treat pain associated with a mild ankle sprain
|
Flector (Reference Product)
n=216 Participants
Flector® (Diclofenac Epolamine Topical Patch 1.3%) (Pfizer)
Diclofenac epolamine: Diclofenac epolamine in a topical patch formulation; applied to the area of sprained ankle; to treat pain associated with a mild ankle sprain
|
Placebo
n=217 Participants
Placebo patch of the test product (Watson Laboratories, Inc.); Identical in appearance and formulated as the test product, omitting the active ingredient, diclofenac epolamine
Placebo: Topical patch not containing diclofenac epolamine applied to the area of sprained ankle; to treat pain associated with a mild ankle sprain
|
|---|---|---|---|
|
Visual Analogue Scale (VAS) Scores at Baseline and Post Treatment
Baseline
|
68.75 score on a scale
Standard Deviation 11.27
|
68.93 score on a scale
Standard Deviation 10.94
|
70.09 score on a scale
Standard Deviation 11.37
|
|
Visual Analogue Scale (VAS) Scores at Baseline and Post Treatment
72 hours after Initial treatment
|
25.83 score on a scale
Standard Deviation 18.19
|
26.16 score on a scale
Standard Deviation 18.47
|
27.16 score on a scale
Standard Deviation 18.18
|
|
Visual Analogue Scale (VAS) Scores at Baseline and Post Treatment
Change from baseline
|
-42.91 score on a scale
Standard Deviation 19.04
|
-42.80 score on a scale
Standard Deviation 20.73
|
-42.88 score on a scale
Standard Deviation 21.66
|
Adverse Events
Diclofenac Epolamine Patch (Test Product)
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Flector (Reference Product)
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Diclofenac Epolamine Patch (Test Product)
n=214 participants at risk
Generic Diclofenac Epolamine Topical Patch 1.3% (Watson Laboratories, Inc.)
Diclofenac epolamine: Diclofenac epolamine in a topical patch formulation; applied to the area of sprained ankle; to treat pain associated with a mild ankle sprain
|
Flector (Reference Product)
n=216 participants at risk
Flector® (Diclofenac Epolamine Topical Patch 1.3%) (Pfizer)
Diclofenac epolamine: Diclofenac epolamine in a topical patch formulation; applied to the area of sprained ankle; to treat pain associated with a mild ankle sprain
|
Placebo
n=217 participants at risk
Placebo patch of the test product (Watson Laboratories, Inc.); Identical in appearance and formulated as the test product, omitting the active ingredient, diclofenac epolamine
Placebo: Topical patch not containing diclofenac epolamine applied to the area of sprained ankle; to treat pain associated with a mild ankle sprain
|
|---|---|---|---|
|
Nervous system disorders
Headache
|
1.4%
3/214 • Baseline up to 3 days (72 hours)
Adverse events were collected from participants who were randomized and received at least one dose of study drug
|
0.46%
1/216 • Baseline up to 3 days (72 hours)
Adverse events were collected from participants who were randomized and received at least one dose of study drug
|
2.8%
6/217 • Baseline up to 3 days (72 hours)
Adverse events were collected from participants who were randomized and received at least one dose of study drug
|
|
Nervous system disorders
Dizziness
|
0.47%
1/214 • Baseline up to 3 days (72 hours)
Adverse events were collected from participants who were randomized and received at least one dose of study drug
|
0.93%
2/216 • Baseline up to 3 days (72 hours)
Adverse events were collected from participants who were randomized and received at least one dose of study drug
|
0.46%
1/217 • Baseline up to 3 days (72 hours)
Adverse events were collected from participants who were randomized and received at least one dose of study drug
|
|
Nervous system disorders
Paraesthesia
|
0.93%
2/214 • Baseline up to 3 days (72 hours)
Adverse events were collected from participants who were randomized and received at least one dose of study drug
|
0.46%
1/216 • Baseline up to 3 days (72 hours)
Adverse events were collected from participants who were randomized and received at least one dose of study drug
|
0.46%
1/217 • Baseline up to 3 days (72 hours)
Adverse events were collected from participants who were randomized and received at least one dose of study drug
|
|
Nervous system disorders
Somnolence
|
0.93%
2/214 • Baseline up to 3 days (72 hours)
Adverse events were collected from participants who were randomized and received at least one dose of study drug
|
0.00%
0/216 • Baseline up to 3 days (72 hours)
Adverse events were collected from participants who were randomized and received at least one dose of study drug
|
0.46%
1/217 • Baseline up to 3 days (72 hours)
Adverse events were collected from participants who were randomized and received at least one dose of study drug
|
|
Nervous system disorders
Hypoaesthesia
|
0.47%
1/214 • Baseline up to 3 days (72 hours)
Adverse events were collected from participants who were randomized and received at least one dose of study drug
|
0.46%
1/216 • Baseline up to 3 days (72 hours)
Adverse events were collected from participants who were randomized and received at least one dose of study drug
|
0.00%
0/217 • Baseline up to 3 days (72 hours)
Adverse events were collected from participants who were randomized and received at least one dose of study drug
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/214 • Baseline up to 3 days (72 hours)
Adverse events were collected from participants who were randomized and received at least one dose of study drug
|
0.46%
1/216 • Baseline up to 3 days (72 hours)
Adverse events were collected from participants who were randomized and received at least one dose of study drug
|
0.46%
1/217 • Baseline up to 3 days (72 hours)
Adverse events were collected from participants who were randomized and received at least one dose of study drug
|
|
General disorders
Application site pruritus
|
0.47%
1/214 • Baseline up to 3 days (72 hours)
Adverse events were collected from participants who were randomized and received at least one dose of study drug
|
1.9%
4/216 • Baseline up to 3 days (72 hours)
Adverse events were collected from participants who were randomized and received at least one dose of study drug
|
2.3%
5/217 • Baseline up to 3 days (72 hours)
Adverse events were collected from participants who were randomized and received at least one dose of study drug
|
|
General disorders
Pain
|
0.00%
0/214 • Baseline up to 3 days (72 hours)
Adverse events were collected from participants who were randomized and received at least one dose of study drug
|
0.46%
1/216 • Baseline up to 3 days (72 hours)
Adverse events were collected from participants who were randomized and received at least one dose of study drug
|
0.92%
2/217 • Baseline up to 3 days (72 hours)
Adverse events were collected from participants who were randomized and received at least one dose of study drug
|
|
General disorders
Application site pain
|
0.00%
0/214 • Baseline up to 3 days (72 hours)
Adverse events were collected from participants who were randomized and received at least one dose of study drug
|
0.00%
0/216 • Baseline up to 3 days (72 hours)
Adverse events were collected from participants who were randomized and received at least one dose of study drug
|
0.92%
2/217 • Baseline up to 3 days (72 hours)
Adverse events were collected from participants who were randomized and received at least one dose of study drug
|
|
General disorders
Swelling
|
0.00%
0/214 • Baseline up to 3 days (72 hours)
Adverse events were collected from participants who were randomized and received at least one dose of study drug
|
0.46%
1/216 • Baseline up to 3 days (72 hours)
Adverse events were collected from participants who were randomized and received at least one dose of study drug
|
0.46%
1/217 • Baseline up to 3 days (72 hours)
Adverse events were collected from participants who were randomized and received at least one dose of study drug
|
|
General disorders
Application site burn
|
0.00%
0/214 • Baseline up to 3 days (72 hours)
Adverse events were collected from participants who were randomized and received at least one dose of study drug
|
0.00%
0/216 • Baseline up to 3 days (72 hours)
Adverse events were collected from participants who were randomized and received at least one dose of study drug
|
0.46%
1/217 • Baseline up to 3 days (72 hours)
Adverse events were collected from participants who were randomized and received at least one dose of study drug
|
|
General disorders
Fatigue
|
0.00%
0/214 • Baseline up to 3 days (72 hours)
Adverse events were collected from participants who were randomized and received at least one dose of study drug
|
0.46%
1/216 • Baseline up to 3 days (72 hours)
Adverse events were collected from participants who were randomized and received at least one dose of study drug
|
0.00%
0/217 • Baseline up to 3 days (72 hours)
Adverse events were collected from participants who were randomized and received at least one dose of study drug
|
|
General disorders
Influenza like illness
|
0.00%
0/214 • Baseline up to 3 days (72 hours)
Adverse events were collected from participants who were randomized and received at least one dose of study drug
|
0.46%
1/216 • Baseline up to 3 days (72 hours)
Adverse events were collected from participants who were randomized and received at least one dose of study drug
|
0.00%
0/217 • Baseline up to 3 days (72 hours)
Adverse events were collected from participants who were randomized and received at least one dose of study drug
|
|
Gastrointestinal disorders
Nausea
|
0.47%
1/214 • Baseline up to 3 days (72 hours)
Adverse events were collected from participants who were randomized and received at least one dose of study drug
|
1.4%
3/216 • Baseline up to 3 days (72 hours)
Adverse events were collected from participants who were randomized and received at least one dose of study drug
|
0.00%
0/217 • Baseline up to 3 days (72 hours)
Adverse events were collected from participants who were randomized and received at least one dose of study drug
|
|
Gastrointestinal disorders
Dyspepsia
|
0.47%
1/214 • Baseline up to 3 days (72 hours)
Adverse events were collected from participants who were randomized and received at least one dose of study drug
|
0.00%
0/216 • Baseline up to 3 days (72 hours)
Adverse events were collected from participants who were randomized and received at least one dose of study drug
|
0.46%
1/217 • Baseline up to 3 days (72 hours)
Adverse events were collected from participants who were randomized and received at least one dose of study drug
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/214 • Baseline up to 3 days (72 hours)
Adverse events were collected from participants who were randomized and received at least one dose of study drug
|
0.00%
0/216 • Baseline up to 3 days (72 hours)
Adverse events were collected from participants who were randomized and received at least one dose of study drug
|
0.46%
1/217 • Baseline up to 3 days (72 hours)
Adverse events were collected from participants who were randomized and received at least one dose of study drug
|
|
Gastrointestinal disorders
Abdominal pain
|
0.47%
1/214 • Baseline up to 3 days (72 hours)
Adverse events were collected from participants who were randomized and received at least one dose of study drug
|
0.00%
0/216 • Baseline up to 3 days (72 hours)
Adverse events were collected from participants who were randomized and received at least one dose of study drug
|
0.00%
0/217 • Baseline up to 3 days (72 hours)
Adverse events were collected from participants who were randomized and received at least one dose of study drug
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/214 • Baseline up to 3 days (72 hours)
Adverse events were collected from participants who were randomized and received at least one dose of study drug
|
0.00%
0/216 • Baseline up to 3 days (72 hours)
Adverse events were collected from participants who were randomized and received at least one dose of study drug
|
0.46%
1/217 • Baseline up to 3 days (72 hours)
Adverse events were collected from participants who were randomized and received at least one dose of study drug
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/214 • Baseline up to 3 days (72 hours)
Adverse events were collected from participants who were randomized and received at least one dose of study drug
|
0.00%
0/216 • Baseline up to 3 days (72 hours)
Adverse events were collected from participants who were randomized and received at least one dose of study drug
|
0.46%
1/217 • Baseline up to 3 days (72 hours)
Adverse events were collected from participants who were randomized and received at least one dose of study drug
|
|
Gastrointestinal disorders
Dysphagia
|
0.47%
1/214 • Baseline up to 3 days (72 hours)
Adverse events were collected from participants who were randomized and received at least one dose of study drug
|
0.00%
0/216 • Baseline up to 3 days (72 hours)
Adverse events were collected from participants who were randomized and received at least one dose of study drug
|
0.00%
0/217 • Baseline up to 3 days (72 hours)
Adverse events were collected from participants who were randomized and received at least one dose of study drug
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/214 • Baseline up to 3 days (72 hours)
Adverse events were collected from participants who were randomized and received at least one dose of study drug
|
0.46%
1/216 • Baseline up to 3 days (72 hours)
Adverse events were collected from participants who were randomized and received at least one dose of study drug
|
0.00%
0/217 • Baseline up to 3 days (72 hours)
Adverse events were collected from participants who were randomized and received at least one dose of study drug
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.47%
1/214 • Baseline up to 3 days (72 hours)
Adverse events were collected from participants who were randomized and received at least one dose of study drug
|
0.93%
2/216 • Baseline up to 3 days (72 hours)
Adverse events were collected from participants who were randomized and received at least one dose of study drug
|
0.92%
2/217 • Baseline up to 3 days (72 hours)
Adverse events were collected from participants who were randomized and received at least one dose of study drug
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.47%
1/214 • Baseline up to 3 days (72 hours)
Adverse events were collected from participants who were randomized and received at least one dose of study drug
|
0.00%
0/216 • Baseline up to 3 days (72 hours)
Adverse events were collected from participants who were randomized and received at least one dose of study drug
|
0.46%
1/217 • Baseline up to 3 days (72 hours)
Adverse events were collected from participants who were randomized and received at least one dose of study drug
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/214 • Baseline up to 3 days (72 hours)
Adverse events were collected from participants who were randomized and received at least one dose of study drug
|
0.00%
0/216 • Baseline up to 3 days (72 hours)
Adverse events were collected from participants who were randomized and received at least one dose of study drug
|
0.46%
1/217 • Baseline up to 3 days (72 hours)
Adverse events were collected from participants who were randomized and received at least one dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.47%
1/214 • Baseline up to 3 days (72 hours)
Adverse events were collected from participants who were randomized and received at least one dose of study drug
|
0.00%
0/216 • Baseline up to 3 days (72 hours)
Adverse events were collected from participants who were randomized and received at least one dose of study drug
|
0.00%
0/217 • Baseline up to 3 days (72 hours)
Adverse events were collected from participants who were randomized and received at least one dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.47%
1/214 • Baseline up to 3 days (72 hours)
Adverse events were collected from participants who were randomized and received at least one dose of study drug
|
0.00%
0/216 • Baseline up to 3 days (72 hours)
Adverse events were collected from participants who were randomized and received at least one dose of study drug
|
0.00%
0/217 • Baseline up to 3 days (72 hours)
Adverse events were collected from participants who were randomized and received at least one dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Muscle fatigue
|
0.47%
1/214 • Baseline up to 3 days (72 hours)
Adverse events were collected from participants who were randomized and received at least one dose of study drug
|
0.00%
0/216 • Baseline up to 3 days (72 hours)
Adverse events were collected from participants who were randomized and received at least one dose of study drug
|
0.00%
0/217 • Baseline up to 3 days (72 hours)
Adverse events were collected from participants who were randomized and received at least one dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/214 • Baseline up to 3 days (72 hours)
Adverse events were collected from participants who were randomized and received at least one dose of study drug
|
0.46%
1/216 • Baseline up to 3 days (72 hours)
Adverse events were collected from participants who were randomized and received at least one dose of study drug
|
0.00%
0/217 • Baseline up to 3 days (72 hours)
Adverse events were collected from participants who were randomized and received at least one dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Tendon pain
|
0.00%
0/214 • Baseline up to 3 days (72 hours)
Adverse events were collected from participants who were randomized and received at least one dose of study drug
|
0.00%
0/216 • Baseline up to 3 days (72 hours)
Adverse events were collected from participants who were randomized and received at least one dose of study drug
|
0.46%
1/217 • Baseline up to 3 days (72 hours)
Adverse events were collected from participants who were randomized and received at least one dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/214 • Baseline up to 3 days (72 hours)
Adverse events were collected from participants who were randomized and received at least one dose of study drug
|
0.46%
1/216 • Baseline up to 3 days (72 hours)
Adverse events were collected from participants who were randomized and received at least one dose of study drug
|
0.46%
1/217 • Baseline up to 3 days (72 hours)
Adverse events were collected from participants who were randomized and received at least one dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.47%
1/214 • Baseline up to 3 days (72 hours)
Adverse events were collected from participants who were randomized and received at least one dose of study drug
|
0.00%
0/216 • Baseline up to 3 days (72 hours)
Adverse events were collected from participants who were randomized and received at least one dose of study drug
|
0.00%
0/217 • Baseline up to 3 days (72 hours)
Adverse events were collected from participants who were randomized and received at least one dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
0.00%
0/214 • Baseline up to 3 days (72 hours)
Adverse events were collected from participants who were randomized and received at least one dose of study drug
|
0.46%
1/216 • Baseline up to 3 days (72 hours)
Adverse events were collected from participants who were randomized and received at least one dose of study drug
|
0.00%
0/217 • Baseline up to 3 days (72 hours)
Adverse events were collected from participants who were randomized and received at least one dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory fatigue
|
0.00%
0/214 • Baseline up to 3 days (72 hours)
Adverse events were collected from participants who were randomized and received at least one dose of study drug
|
0.46%
1/216 • Baseline up to 3 days (72 hours)
Adverse events were collected from participants who were randomized and received at least one dose of study drug
|
0.00%
0/217 • Baseline up to 3 days (72 hours)
Adverse events were collected from participants who were randomized and received at least one dose of study drug
|
|
Investigations
Weight decreased
|
0.47%
1/214 • Baseline up to 3 days (72 hours)
Adverse events were collected from participants who were randomized and received at least one dose of study drug
|
0.93%
2/216 • Baseline up to 3 days (72 hours)
Adverse events were collected from participants who were randomized and received at least one dose of study drug
|
0.00%
0/217 • Baseline up to 3 days (72 hours)
Adverse events were collected from participants who were randomized and received at least one dose of study drug
|
|
Investigations
Heart rate increased
|
0.00%
0/214 • Baseline up to 3 days (72 hours)
Adverse events were collected from participants who were randomized and received at least one dose of study drug
|
0.46%
1/216 • Baseline up to 3 days (72 hours)
Adverse events were collected from participants who were randomized and received at least one dose of study drug
|
0.00%
0/217 • Baseline up to 3 days (72 hours)
Adverse events were collected from participants who were randomized and received at least one dose of study drug
|
|
Eye disorders
Eye pruritus
|
0.47%
1/214 • Baseline up to 3 days (72 hours)
Adverse events were collected from participants who were randomized and received at least one dose of study drug
|
0.00%
0/216 • Baseline up to 3 days (72 hours)
Adverse events were collected from participants who were randomized and received at least one dose of study drug
|
0.00%
0/217 • Baseline up to 3 days (72 hours)
Adverse events were collected from participants who were randomized and received at least one dose of study drug
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/214 • Baseline up to 3 days (72 hours)
Adverse events were collected from participants who were randomized and received at least one dose of study drug
|
0.00%
0/216 • Baseline up to 3 days (72 hours)
Adverse events were collected from participants who were randomized and received at least one dose of study drug
|
0.46%
1/217 • Baseline up to 3 days (72 hours)
Adverse events were collected from participants who were randomized and received at least one dose of study drug
|
|
Infections and infestations
Nasopharyngitis
|
0.47%
1/214 • Baseline up to 3 days (72 hours)
Adverse events were collected from participants who were randomized and received at least one dose of study drug
|
0.00%
0/216 • Baseline up to 3 days (72 hours)
Adverse events were collected from participants who were randomized and received at least one dose of study drug
|
0.00%
0/217 • Baseline up to 3 days (72 hours)
Adverse events were collected from participants who were randomized and received at least one dose of study drug
|
|
Vascular disorders
Peripheral coldness
|
0.00%
0/214 • Baseline up to 3 days (72 hours)
Adverse events were collected from participants who were randomized and received at least one dose of study drug
|
0.46%
1/216 • Baseline up to 3 days (72 hours)
Adverse events were collected from participants who were randomized and received at least one dose of study drug
|
0.00%
0/217 • Baseline up to 3 days (72 hours)
Adverse events were collected from participants who were randomized and received at least one dose of study drug
|
Additional Information
Senior Director, Global Gx Clinical R&D- PD/CE Studies
Teva Pharmaceuticals USA, Inc
Phone: 1-888-483-8279
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The results of the study may be published or presented by the Investigator(s) after the review by, and in consultation and agreement with the Sponsor, and such that confidential or proprietary information is not disclosed.
- Publication restrictions are in place
Restriction type: OTHER