Trial Outcomes & Findings for A Study Comparing Diclofenac Sodium Gel 3% to Solaraze® (Diclofenac Sodium) Gel 3% in the Treatment of Actinic Keratosis (NCT NCT01962987)
NCT ID: NCT01962987
Last Updated: 2020-07-20
Results Overview
The primary measure of bioequivalence will be evaluated using those patients who complete the study according to the (PP) population.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
476 participants
Primary outcome timeframe
90 days
Results posted on
2020-07-20
Participant Flow
Participant milestones
| Measure |
Diclofenac Sodium 3% Gel
The test product diclofenac sodium 3% test gel is applied to lesion areas twice daily. It is to be smoothed onto the affected skin gently. The amount needed depends upon the size of the lesion site. Assure that enough Test Gel is applied to adequately cover each lesion. Normally 0.5 g of gel is used on each 5 cm x 5 cm lesion site.
Diclofenac sodium: Topical administration of approximately 0.5g twice daily to the 25 sq cm treatment area for 60 days.
|
Solaraze( Diclofenac Sodium) 3% Gel
The Reference diclofenac sodium 3% gel (Solaraze®) is applied to lesion areas twice daily. It is to be smoothed onto the affected skin gently. The amount needed depends upon the size of the lesion site. Assure that enough Reference (Solaraze®) Gel is applied to adequately cover each lesion. Normally 0.5 g of gel is used on each 5 cm x 5 cm lesion site.
Diclofenac sodium: Topical administration of approximately 0.5g twice daily to the 25 sq cm treatment area for 60 days.
|
Vehicle Gel
The vehicle (placebo) gel (contains no active ingredient) is applied to lesion areas twice daily. It is to be smoothed onto the affected skin gently. The amount needed depends upon the size of the lesion site. Assure that enough placebo gel is applied to adequately cover each lesion. Normally 0.5 g of gel is used on each 5 cm x 5 cm lesion site.
Placebo: Topical administration of approximately 0.5g twice daily to the 25 sq cm treatment area for 60 days.
|
|---|---|---|---|
|
Overall Study
STARTED
|
190
|
191
|
95
|
|
Overall Study
COMPLETED
|
160
|
163
|
83
|
|
Overall Study
NOT COMPLETED
|
30
|
28
|
12
|
Reasons for withdrawal
| Measure |
Diclofenac Sodium 3% Gel
The test product diclofenac sodium 3% test gel is applied to lesion areas twice daily. It is to be smoothed onto the affected skin gently. The amount needed depends upon the size of the lesion site. Assure that enough Test Gel is applied to adequately cover each lesion. Normally 0.5 g of gel is used on each 5 cm x 5 cm lesion site.
Diclofenac sodium: Topical administration of approximately 0.5g twice daily to the 25 sq cm treatment area for 60 days.
|
Solaraze( Diclofenac Sodium) 3% Gel
The Reference diclofenac sodium 3% gel (Solaraze®) is applied to lesion areas twice daily. It is to be smoothed onto the affected skin gently. The amount needed depends upon the size of the lesion site. Assure that enough Reference (Solaraze®) Gel is applied to adequately cover each lesion. Normally 0.5 g of gel is used on each 5 cm x 5 cm lesion site.
Diclofenac sodium: Topical administration of approximately 0.5g twice daily to the 25 sq cm treatment area for 60 days.
|
Vehicle Gel
The vehicle (placebo) gel (contains no active ingredient) is applied to lesion areas twice daily. It is to be smoothed onto the affected skin gently. The amount needed depends upon the size of the lesion site. Assure that enough placebo gel is applied to adequately cover each lesion. Normally 0.5 g of gel is used on each 5 cm x 5 cm lesion site.
Placebo: Topical administration of approximately 0.5g twice daily to the 25 sq cm treatment area for 60 days.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
4
|
4
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
|
Overall Study
Non compliance with dosing requirements
|
4
|
2
|
0
|
|
Overall Study
Miscellaneous
|
1
|
9
|
2
|
|
Overall Study
Restricted medication
|
5
|
1
|
1
|
|
Overall Study
Serious Adverse Event
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
11
|
10
|
6
|
|
Overall Study
Randomized in Error
|
4
|
2
|
2
|
Baseline Characteristics
A Study Comparing Diclofenac Sodium Gel 3% to Solaraze® (Diclofenac Sodium) Gel 3% in the Treatment of Actinic Keratosis
Baseline characteristics by cohort
| Measure |
Diclofenac Sodium 3% Gel
n=188 Participants
The test product diclofenac sodium 3% test gel is applied to lesion areas twice daily. It is to be smoothed onto the affected skin gently. The amount needed depends upon the size of the lesion site. Assure that enough Test Gel is applied to adequately cover each lesion. Normally 0.5 g of gel is used on each 5 cm x 5 cm lesion site.
Diclofenac sodium: Topical administration of approximately 0.5g twice daily to the 25 sq cm treatment area for 60 days.
|
Solaraze( Diclofenac Sodium) 3% Gel
n=189 Participants
The Reference diclofenac sodium 3% gel (Solaraze®) is applied to lesion areas twice daily. It is to be smoothed onto the affected skin gently. The amount needed depends upon the size of the lesion site. Assure that enough Reference (Solaraze®) Gel is applied to adequately cover each lesion. Normally 0.5 g of gel is used on each 5 cm x 5 cm lesion site.
Diclofenac sodium: Topical administration of approximately 0.5g twice daily to the 25 sq cm treatment area for 60 days.
|
Vehicle Gel
n=93 Participants
The vehicle (placebo) gel (contains no active ingredient) is applied to lesion areas twice daily. It is to be smoothed onto the affected skin gently. The amount needed depends upon the size of the lesion site. Assure that enough placebo gel is applied to adequately cover each lesion. Normally 0.5 g of gel is used on each 5 cm x 5 cm lesion site.
Placebo: Topical administration of approximately 0.5g twice daily to the 25 sq cm treatment area for 60 days.
|
Total
n=470 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
65.34 years
STANDARD_DEVIATION 11.42 • n=5 Participants
|
66.24 years
STANDARD_DEVIATION 11.37 • n=7 Participants
|
65.55 years
STANDARD_DEVIATION 11.00 • n=5 Participants
|
65.71 years
STANDARD_DEVIATION 11.26 • n=4 Participants
|
|
Sex: Female, Male
Female
|
56 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
136 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
132 Participants
n=5 Participants
|
135 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
334 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
21 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
48 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
167 Participants
n=5 Participants
|
170 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
422 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
188 Participants
n=5 Participants
|
189 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
470 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 90 daysPopulation: Analysis provided using the Per-Protocol Population.
The primary measure of bioequivalence will be evaluated using those patients who complete the study according to the (PP) population.
Outcome measures
| Measure |
Diclofenac Sodium 3% Gel
n=139 Participants
The test product diclofenac sodium 3% test gel is applied to lesion areas twice daily. It is to be smoothed onto the affected skin gently. The amount needed depends upon the size of the lesion site. Assure that enough Test Gel is applied to adequately cover each lesion. Normally 0.5 g of gel is used on each 5 cm x 5 cm lesion site.
Diclofenac sodium: Topical administration of approximately 0.5g twice daily to the 25 sq cm treatment area for 60 days.
|
Solaraze( Diclofenac Sodium) 3% Gel
n=148 Participants
The Reference diclofenac sodium 3% gel (Solaraze®) is applied to lesion areas twice daily. It is to be smoothed onto the affected skin gently. The amount needed depends upon the size of the lesion site. Assure that enough Reference (Solaraze®) Gel is applied to adequately cover each lesion. Normally 0.5 g of gel is used on each 5 cm x 5 cm lesion site.
Diclofenac sodium: Topical administration of approximately 0.5g twice daily to the 25 sq cm treatment area for 60 days.
|
Vehicle Gel
n=81 Participants
The vehicle (placebo) gel (contains no active ingredient) is applied to lesion areas twice daily. It is to be smoothed onto the affected skin gently. The amount needed depends upon the size of the lesion site. Assure that enough placebo gel is applied to adequately cover each lesion. Normally 0.5 g of gel is used on each 5 cm x 5 cm lesion site.
Placebo: Topical administration of approximately 0.5g twice daily to the 25 sq cm treatment area for 60 days.
|
|---|---|---|---|
|
Percentage of Patients With 100% Clearance of All AK Lesions Within the Treatment Area Assessed at Day 90
Cure - 100% clearance of all AK lesions at Day 90
|
31 Participants
|
32 Participants
|
7 Participants
|
|
Percentage of Patients With 100% Clearance of All AK Lesions Within the Treatment Area Assessed at Day 90
No Cure - Not 100% Clearance of lesions at Day 90
|
108 Participants
|
116 Participants
|
74 Participants
|
Adverse Events
Diclofenac Sodium 3% Gel
Serious events: 7 serious events
Other events: 102 other events
Deaths: 0 deaths
Solaraze( Diclofenac Sodium) 3% Gel
Serious events: 4 serious events
Other events: 91 other events
Deaths: 0 deaths
Vehicle Gel
Serious events: 2 serious events
Other events: 35 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Diclofenac Sodium 3% Gel
n=188 participants at risk
The test product diclofenac sodium 3% test gel is applied to lesion areas twice daily. It is to be smoothed onto the affected skin gently. The amount needed depends upon the size of the lesion site. Assure that enough Test Gel is applied to adequately cover each lesion. Normally 0.5 g of gel is used on each 5 cm x 5 cm lesion site.
Diclofenac sodium: Topical administration of approximately 0.5g twice daily to the 25 sq cm treatment area for 60 days.
|
Solaraze( Diclofenac Sodium) 3% Gel
n=189 participants at risk
The Reference diclofenac sodium 3% gel (Solaraze®) is applied to lesion areas twice daily. It is to be smoothed onto the affected skin gently. The amount needed depends upon the size of the lesion site. Assure that enough Reference (Solaraze®) Gel is applied to adequately cover each lesion. Normally 0.5 g of gel is used on each 5 cm x 5 cm lesion site.
Diclofenac sodium: Topical administration of approximately 0.5g twice daily to the 25 sq cm treatment area for 60 days.
|
Vehicle Gel
n=93 participants at risk
The vehicle (placebo) gel (contains no active ingredient) is applied to lesion areas twice daily. It is to be smoothed onto the affected skin gently. The amount needed depends upon the size of the lesion site. Assure that enough placebo gel is applied to adequately cover each lesion. Normally 0.5 g of gel is used on each 5 cm x 5 cm lesion site.
Placebo: Topical administration of approximately 0.5g twice daily to the 25 sq cm treatment area for 60 days.
|
|---|---|---|---|
|
Cardiac disorders
Cardiac disorder
|
0.53%
1/188 • 3 months
|
0.00%
0/189 • 3 months
|
0.00%
0/93 • 3 months
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/188 • 3 months
|
0.00%
0/189 • 3 months
|
1.1%
1/93 • 3 months
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/188 • 3 months
|
1.1%
2/189 • 3 months
|
0.00%
0/93 • 3 months
|
|
Gastrointestinal disorders
Nausea
|
0.53%
1/188 • 3 months
|
0.00%
0/189 • 3 months
|
0.00%
0/93 • 3 months
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/188 • 3 months
|
0.53%
1/189 • 3 months
|
0.00%
0/93 • 3 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cardiac myxoma
|
0.53%
1/188 • 3 months
|
0.00%
0/189 • 3 months
|
0.00%
0/93 • 3 months
|
|
Nervous system disorders
Cerebrovascular accident
|
0.53%
1/188 • 3 months
|
0.00%
0/189 • 3 months
|
0.00%
0/93 • 3 months
|
|
Nervous system disorders
Presyncope
|
0.53%
1/188 • 3 months
|
0.00%
0/189 • 3 months
|
0.00%
0/93 • 3 months
|
|
Nervous system disorders
Syncope
|
0.53%
1/188 • 3 months
|
0.00%
0/189 • 3 months
|
0.00%
0/93 • 3 months
|
|
Psychiatric disorders
Alcoholism
|
0.53%
1/188 • 3 months
|
0.00%
0/189 • 3 months
|
0.00%
0/93 • 3 months
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/188 • 3 months
|
0.53%
1/189 • 3 months
|
0.00%
0/93 • 3 months
|
|
Surgical and medical procedures
Angioplasty
|
0.00%
0/188 • 3 months
|
0.00%
0/189 • 3 months
|
1.1%
1/93 • 3 months
|
Other adverse events
| Measure |
Diclofenac Sodium 3% Gel
n=188 participants at risk
The test product diclofenac sodium 3% test gel is applied to lesion areas twice daily. It is to be smoothed onto the affected skin gently. The amount needed depends upon the size of the lesion site. Assure that enough Test Gel is applied to adequately cover each lesion. Normally 0.5 g of gel is used on each 5 cm x 5 cm lesion site.
Diclofenac sodium: Topical administration of approximately 0.5g twice daily to the 25 sq cm treatment area for 60 days.
|
Solaraze( Diclofenac Sodium) 3% Gel
n=189 participants at risk
The Reference diclofenac sodium 3% gel (Solaraze®) is applied to lesion areas twice daily. It is to be smoothed onto the affected skin gently. The amount needed depends upon the size of the lesion site. Assure that enough Reference (Solaraze®) Gel is applied to adequately cover each lesion. Normally 0.5 g of gel is used on each 5 cm x 5 cm lesion site.
Diclofenac sodium: Topical administration of approximately 0.5g twice daily to the 25 sq cm treatment area for 60 days.
|
Vehicle Gel
n=93 participants at risk
The vehicle (placebo) gel (contains no active ingredient) is applied to lesion areas twice daily. It is to be smoothed onto the affected skin gently. The amount needed depends upon the size of the lesion site. Assure that enough placebo gel is applied to adequately cover each lesion. Normally 0.5 g of gel is used on each 5 cm x 5 cm lesion site.
Placebo: Topical administration of approximately 0.5g twice daily to the 25 sq cm treatment area for 60 days.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/188 • 3 months
|
0.53%
1/189 • Number of events 1 • 3 months
|
0.00%
0/93 • 3 months
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.53%
1/188 • Number of events 1 • 3 months
|
0.00%
0/189 • 3 months
|
0.00%
0/93 • 3 months
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.00%
0/188 • 3 months
|
0.53%
1/189 • Number of events 1 • 3 months
|
0.00%
0/93 • 3 months
|
|
Cardiac disorders
Atrial fibrillation
|
1.6%
3/188 • Number of events 3 • 3 months
|
0.00%
0/189 • 3 months
|
0.00%
0/93 • 3 months
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/188 • 3 months
|
0.53%
1/189 • Number of events 1 • 3 months
|
0.00%
0/93 • 3 months
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.53%
1/188 • Number of events 1 • 3 months
|
0.00%
0/189 • 3 months
|
0.00%
0/93 • 3 months
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/188 • 3 months
|
0.00%
0/189 • 3 months
|
1.1%
1/93 • Number of events 1 • 3 months
|
|
Cardiac disorders
Bundle branch block right
|
0.00%
0/188 • 3 months
|
0.53%
1/189 • Number of events 1 • 3 months
|
0.00%
0/93 • 3 months
|
|
Cardiac disorders
Cardiac disorder
|
0.53%
1/188 • Number of events 1 • 3 months
|
0.00%
0/189 • 3 months
|
0.00%
0/93 • 3 months
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/188 • 3 months
|
0.53%
1/189 • Number of events 1 • 3 months
|
0.00%
0/93 • 3 months
|
|
Cardiac disorders
Mitral valce incompetence
|
0.53%
1/188 • Number of events 1 • 3 months
|
0.00%
0/189 • 3 months
|
0.00%
0/93 • 3 months
|
|
Cardiac disorders
Sinus arrhythmia
|
0.53%
1/188 • Number of events 1 • 3 months
|
0.00%
0/189 • 3 months
|
0.00%
0/93 • 3 months
|
|
Cardiac disorders
Tricuspid valve incompetence
|
0.53%
1/188 • Number of events 1 • 3 months
|
0.00%
0/189 • 3 months
|
0.00%
0/93 • 3 months
|
|
Ear and labyrinth disorders
Cerumen impaction
|
0.53%
1/188 • Number of events 1 • 3 months
|
0.00%
0/189 • 3 months
|
0.00%
0/93 • 3 months
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/188 • 3 months
|
0.53%
1/189 • Number of events 1 • 3 months
|
0.00%
0/93 • 3 months
|
|
Cardiac disorders
Vertigo
|
0.53%
1/188 • Number of events 2 • 3 months
|
0.00%
0/189 • 3 months
|
1.1%
1/93 • Number of events 1 • 3 months
|
|
Eye disorders
Cataract
|
0.53%
1/188 • Number of events 1 • 3 months
|
0.00%
0/189 • 3 months
|
0.00%
0/93 • 3 months
|
|
Eye disorders
Eye Swelling
|
0.00%
0/188 • 3 months
|
0.53%
1/189 • Number of events 1 • 3 months
|
0.00%
0/93 • 3 months
|
|
Eye disorders
Periorbital oedema
|
0.53%
1/188 • Number of events 1 • 3 months
|
0.00%
0/189 • 3 months
|
0.00%
0/93 • 3 months
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.53%
1/188 • Number of events 1 • 3 months
|
0.00%
0/189 • 3 months
|
0.00%
0/93 • 3 months
|
|
Gastrointestinal disorders
Colitis
|
0.53%
1/188 • Number of events 1 • 3 months
|
0.00%
0/189 • 3 months
|
0.00%
0/93 • 3 months
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/188 • 3 months
|
0.53%
1/189 • Number of events 1 • 3 months
|
1.1%
1/93 • Number of events 1 • 3 months
|
|
Gastrointestinal disorders
Dry mouth
|
0.53%
1/188 • Number of events 1 • 3 months
|
0.53%
1/189 • Number of events 1 • 3 months
|
0.00%
0/93 • 3 months
|
|
Gastrointestinal disorders
Dyspepsia
|
0.53%
1/188 • Number of events 1 • 3 months
|
0.00%
0/189 • 3 months
|
0.00%
0/93 • 3 months
|
|
Gastrointestinal disorders
Dysphagia
|
0.53%
1/188 • Number of events 1 • 3 months
|
0.00%
0/189 • 3 months
|
0.00%
0/93 • 3 months
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.53%
1/188 • Number of events 1 • 3 months
|
0.00%
0/189 • 3 months
|
0.00%
0/93 • 3 months
|
|
Gastrointestinal disorders
Gastrooesophageal reflux
|
0.00%
0/188 • 3 months
|
0.00%
0/189 • 3 months
|
1.1%
1/93 • Number of events 1 • 3 months
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/188 • 3 months
|
0.00%
0/189 • 3 months
|
1.1%
1/93 • Number of events 1 • 3 months
|
|
Gastrointestinal disorders
Haemorrhoidal heamorrhage
|
0.53%
1/188 • Number of events 1 • 3 months
|
0.00%
0/189 • 3 months
|
0.00%
0/93 • 3 months
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/188 • 3 months
|
0.53%
1/189 • Number of events 1 • 3 months
|
0.00%
0/93 • 3 months
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/188 • 3 months
|
1.1%
2/189 • Number of events 2 • 3 months
|
1.1%
1/93 • Number of events 1 • 3 months
|
|
Gastrointestinal disorders
Nausea
|
1.1%
2/188 • Number of events 2 • 3 months
|
0.53%
1/189 • Number of events 1 • 3 months
|
2.2%
2/93 • Number of events 3 • 3 months
|
|
Gastrointestinal disorders
Oral discomfort
|
0.00%
0/188 • 3 months
|
0.53%
1/189 • Number of events 1 • 3 months
|
0.00%
0/93 • 3 months
|
|
Gastrointestinal disorders
Toothache
|
0.53%
1/188 • Number of events 1 • 3 months
|
0.00%
0/189 • 3 months
|
0.00%
0/93 • 3 months
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/188 • 3 months
|
0.00%
0/189 • 3 months
|
1.1%
1/93 • Number of events 1 • 3 months
|
|
General disorders
Application site alopecia
|
0.00%
0/188 • 3 months
|
0.00%
0/189 • 3 months
|
1.1%
1/93 • Number of events 1 • 3 months
|
|
General disorders
Application site burn
|
0.53%
1/188 • Number of events 1 • 3 months
|
0.00%
0/189 • 3 months
|
0.00%
0/93 • 3 months
|
|
General disorders
Application site dermatitis
|
3.2%
6/188 • Number of events 6 • 3 months
|
1.6%
3/189 • Number of events 3 • 3 months
|
0.00%
0/93 • 3 months
|
|
General disorders
Application site dryness
|
0.53%
1/188 • Number of events 1 • 3 months
|
0.00%
0/189 • 3 months
|
1.1%
1/93 • Number of events 2 • 3 months
|
|
General disorders
Application site exfoliation
|
0.00%
0/188 • 3 months
|
1.6%
3/189 • Number of events 5 • 3 months
|
0.00%
0/93 • 3 months
|
|
General disorders
Application site haemorrhage
|
0.00%
0/188 • 3 months
|
0.53%
1/189 • Number of events 1 • 3 months
|
0.00%
0/93 • 3 months
|
|
General disorders
Application site irritation
|
0.53%
1/188 • Number of events 1 • 3 months
|
0.00%
0/189 • 3 months
|
0.00%
0/93 • 3 months
|
|
General disorders
Application site pain
|
1.1%
2/188 • Number of events 2 • 3 months
|
0.53%
1/189 • Number of events 1 • 3 months
|
2.2%
2/93 • Number of events 2 • 3 months
|
|
General disorders
Application site pruritus
|
1.1%
2/188 • Number of events 2 • 3 months
|
1.1%
2/189 • Number of events 2 • 3 months
|
1.1%
1/93 • Number of events 1 • 3 months
|
|
General disorders
Application site rash
|
0.53%
1/188 • Number of events 3 • 3 months
|
0.00%
0/189 • 3 months
|
0.00%
0/93 • 3 months
|
|
General disorders
Application site reaction
|
0.53%
1/188 • Number of events 1 • 3 months
|
0.53%
1/189 • Number of events 1 • 3 months
|
0.00%
0/93 • 3 months
|
|
General disorders
Application site scab
|
0.53%
1/188 • Number of events 3 • 3 months
|
0.00%
0/189 • 3 months
|
0.00%
0/93 • 3 months
|
|
General disorders
Application site swelling
|
0.00%
0/188 • 3 months
|
1.6%
3/189 • Number of events 3 • 3 months
|
0.00%
0/93 • 3 months
|
|
General disorders
Application site urticaria
|
0.00%
0/188 • 3 months
|
0.53%
1/189 • Number of events 1 • 3 months
|
0.00%
0/93 • 3 months
|
|
General disorders
Application site vesicles
|
0.00%
0/188 • 3 months
|
0.53%
1/189 • Number of events 1 • 3 months
|
0.00%
0/93 • 3 months
|
|
General disorders
Chest discomfort
|
0.00%
0/188 • 3 months
|
0.53%
1/189 • Number of events 1 • 3 months
|
0.00%
0/93 • 3 months
|
|
General disorders
Chills
|
0.00%
0/188 • 3 months
|
1.1%
2/189 • Number of events 2 • 3 months
|
0.00%
0/93 • 3 months
|
|
General disorders
Fatigue
|
0.00%
0/188 • 3 months
|
0.53%
1/189 • Number of events 1 • 3 months
|
0.00%
0/93 • 3 months
|
|
General disorders
Pain
|
1.1%
2/188 • Number of events 2 • 3 months
|
0.00%
0/189 • 3 months
|
0.00%
0/93 • 3 months
|
|
General disorders
Pyrexia
|
0.00%
0/188 • 3 months
|
0.53%
1/189 • Number of events 1 • 3 months
|
0.00%
0/93 • 3 months
|
|
General disorders
Thirst
|
0.53%
1/188 • Number of events 1 • 3 months
|
0.00%
0/189 • 3 months
|
0.00%
0/93 • 3 months
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/188 • 3 months
|
0.53%
1/189 • Number of events 1 • 3 months
|
0.00%
0/93 • 3 months
|
|
Immune system disorders
Seasonal allergy
|
1.1%
2/188 • Number of events 2 • 3 months
|
0.00%
0/189 • 3 months
|
0.00%
0/93 • 3 months
|
|
Infections and infestations
Acarodermatitis
|
0.00%
0/188 • 3 months
|
0.53%
1/189 • Number of events 1 • 3 months
|
0.00%
0/93 • 3 months
|
|
Infections and infestations
Application site infection
|
0.53%
1/188 • Number of events 1 • 3 months
|
0.00%
0/189 • 3 months
|
0.00%
0/93 • 3 months
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/188 • 3 months
|
0.53%
1/189 • Number of events 1 • 3 months
|
0.00%
0/93 • 3 months
|
|
Infections and infestations
Bronchitis
|
0.00%
0/188 • 3 months
|
0.53%
1/189 • Number of events 1 • 3 months
|
3.2%
3/93 • Number of events 3 • 3 months
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/188 • 3 months
|
0.53%
1/189 • Number of events 1 • 3 months
|
0.00%
0/93 • 3 months
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/188 • 3 months
|
0.53%
1/189 • Number of events 1 • 3 months
|
0.00%
0/93 • 3 months
|
|
Infections and infestations
Ear infection
|
0.00%
0/188 • 3 months
|
0.53%
1/189 • Number of events 1 • 3 months
|
0.00%
0/93 • 3 months
|
|
Infections and infestations
Eye infection
|
0.00%
0/188 • 3 months
|
0.00%
0/189 • 3 months
|
1.1%
1/93 • Number of events 1 • 3 months
|
|
Infections and infestations
Gastoenteritis viral
|
0.00%
0/188 • 3 months
|
0.53%
1/189 • Number of events 1 • 3 months
|
0.00%
0/93 • 3 months
|
|
Infections and infestations
Herpes zoster
|
0.53%
1/188 • Number of events 1 • 3 months
|
0.53%
1/189 • Number of events 1 • 3 months
|
0.00%
0/93 • 3 months
|
|
Infections and infestations
Hordeolum
|
0.53%
1/188 • Number of events 1 • 3 months
|
0.00%
0/189 • 3 months
|
0.00%
0/93 • 3 months
|
|
Infections and infestations
Influenza
|
0.53%
1/188 • Number of events 1 • 3 months
|
0.53%
1/189 • Number of events 1 • 3 months
|
0.00%
0/93 • 3 months
|
|
Infections and infestations
Localized infection
|
0.00%
0/188 • 3 months
|
0.00%
0/189 • 3 months
|
1.1%
1/93 • Number of events 3 • 3 months
|
|
Infections and infestations
Nasopharyngitis
|
1.1%
2/188 • Number of events 2 • 3 months
|
0.53%
1/189 • Number of events 1 • 3 months
|
0.00%
0/93 • 3 months
|
|
Infections and infestations
Oral herpes
|
0.53%
1/188 • Number of events 1 • 3 months
|
0.53%
1/189 • Number of events 1 • 3 months
|
0.00%
0/93 • 3 months
|
|
Infections and infestations
Pharyngitis
|
0.53%
1/188 • Number of events 1 • 3 months
|
0.00%
0/189 • 3 months
|
0.00%
0/93 • 3 months
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/188 • 3 months
|
0.53%
1/189 • Number of events 1 • 3 months
|
0.00%
0/93 • 3 months
|
|
Infections and infestations
Sinusitis
|
0.00%
0/188 • 3 months
|
0.53%
1/189 • Number of events 1 • 3 months
|
0.00%
0/93 • 3 months
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/188 • 3 months
|
0.53%
1/189 • Number of events 1 • 3 months
|
0.00%
0/93 • 3 months
|
|
Infections and infestations
Tooth abscess
|
0.53%
1/188 • Number of events 1 • 3 months
|
0.00%
0/189 • 3 months
|
0.00%
0/93 • 3 months
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/188 • 3 months
|
0.53%
1/189 • Number of events 1 • 3 months
|
0.00%
0/93 • 3 months
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/188 • 3 months
|
0.53%
1/189 • Number of events 1 • 3 months
|
0.00%
0/93 • 3 months
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/188 • 3 months
|
0.53%
1/189 • Number of events 1 • 3 months
|
0.00%
0/93 • 3 months
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.53%
1/188 • Number of events 1 • 3 months
|
0.00%
0/189 • 3 months
|
0.00%
0/93 • 3 months
|
|
Injury, poisoning and procedural complications
Fall
|
0.53%
1/188 • Number of events 1 • 3 months
|
0.00%
0/189 • 3 months
|
0.00%
0/93 • 3 months
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.53%
1/188 • Number of events 1 • 3 months
|
0.00%
0/189 • 3 months
|
0.00%
0/93 • 3 months
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/188 • 3 months
|
0.53%
1/189 • Number of events 1 • 3 months
|
0.00%
0/93 • 3 months
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.53%
1/188 • Number of events 1 • 3 months
|
0.00%
0/189 • 3 months
|
0.00%
0/93 • 3 months
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/188 • 3 months
|
0.53%
1/189 • Number of events 1 • 3 months
|
0.00%
0/93 • 3 months
|
|
Investigations
Blood pressure increased
|
0.00%
0/188 • 3 months
|
1.1%
2/189 • Number of events 2 • 3 months
|
0.00%
0/93 • 3 months
|
|
Investigations
Blood uric acid increased
|
0.00%
0/188 • 3 months
|
0.53%
1/189 • Number of events 1 • 3 months
|
0.00%
0/93 • 3 months
|
|
Investigations
Respiratory rate decreased
|
0.53%
1/188 • Number of events 1 • 3 months
|
0.00%
0/189 • 3 months
|
0.00%
0/93 • 3 months
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/188 • 3 months
|
0.53%
1/189 • Number of events 1 • 3 months
|
0.00%
0/93 • 3 months
|
|
Metabolism and nutrition disorders
Gout
|
1.1%
2/188 • Number of events 2 • 3 months
|
0.53%
1/189 • Number of events 1 • 3 months
|
0.00%
0/93 • 3 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.53%
1/188 • Number of events 1 • 3 months
|
0.53%
1/189 • Number of events 1 • 3 months
|
1.1%
1/93 • Number of events 1 • 3 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.53%
1/188 • Number of events 1 • 3 months
|
0.00%
0/189 • 3 months
|
0.00%
0/93 • 3 months
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.53%
1/188 • Number of events 1 • 3 months
|
0.00%
0/189 • 3 months
|
0.00%
0/93 • 3 months
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.53%
1/188 • Number of events 1 • 3 months
|
0.00%
0/189 • 3 months
|
0.00%
0/93 • 3 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.53%
1/188 • Number of events 1 • 3 months
|
0.00%
0/189 • 3 months
|
0.00%
0/93 • 3 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.53%
1/188 • Number of events 1 • 3 months
|
0.53%
1/189 • Number of events 1 • 3 months
|
0.00%
0/93 • 3 months
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.53%
1/188 • Number of events 1 • 3 months
|
0.00%
0/189 • 3 months
|
0.00%
0/93 • 3 months
|
|
Musculoskeletal and connective tissue disorders
Osteitis
|
0.00%
0/188 • 3 months
|
0.53%
1/189 • Number of events 1 • 3 months
|
0.00%
0/93 • 3 months
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/188 • 3 months
|
0.53%
1/189 • Number of events 1 • 3 months
|
1.1%
1/93 • Number of events 1 • 3 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acrochordon
|
0.00%
0/188 • 3 months
|
0.53%
1/189 • Number of events 1 • 3 months
|
0.00%
0/93 • 3 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cardiac myxoma
|
0.53%
1/188 • Number of events 1 • 3 months
|
0.00%
0/189 • 3 months
|
0.00%
0/93 • 3 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanoma recurrent
|
0.00%
0/188 • 3 months
|
0.53%
1/189 • Number of events 1 • 3 months
|
0.00%
0/93 • 3 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm
|
0.53%
1/188 • Number of events 1 • 3 months
|
0.00%
0/189 • 3 months
|
0.00%
0/93 • 3 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm skin
|
0.00%
0/188 • 3 months
|
0.00%
0/189 • 3 months
|
1.1%
1/93 • Number of events 1 • 3 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/188 • 3 months
|
0.00%
0/189 • 3 months
|
2.2%
2/93 • Number of events 2 • 3 months
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/188 • 3 months
|
0.53%
1/189 • Number of events 1 • 3 months
|
0.00%
0/93 • 3 months
|
|
Nervous system disorders
Carotid artery stenosis
|
0.53%
1/188 • Number of events 1 • 3 months
|
0.00%
0/189 • 3 months
|
0.00%
0/93 • 3 months
|
|
Nervous system disorders
Cerebrovascular accident
|
0.53%
1/188 • Number of events 1 • 3 months
|
0.00%
0/189 • 3 months
|
0.00%
0/93 • 3 months
|
|
Nervous system disorders
Dementia
|
0.53%
1/188 • Number of events 1 • 3 months
|
0.00%
0/189 • 3 months
|
0.00%
0/93 • 3 months
|
|
Nervous system disorders
Dizziness
|
1.1%
2/188 • Number of events 2 • 3 months
|
1.1%
2/189 • Number of events 2 • 3 months
|
2.2%
2/93 • Number of events 2 • 3 months
|
|
Nervous system disorders
Headache
|
2.7%
5/188 • Number of events 10 • 3 months
|
3.7%
7/189 • Number of events 9 • 3 months
|
3.2%
3/93 • Number of events 4 • 3 months
|
|
Nervous system disorders
Hyperaesthesia
|
0.53%
1/188 • Number of events 1 • 3 months
|
0.00%
0/189 • 3 months
|
0.00%
0/93 • 3 months
|
|
Nervous system disorders
Migraine
|
0.00%
0/188 • 3 months
|
1.1%
2/189 • Number of events 2 • 3 months
|
1.1%
1/93 • Number of events 1 • 3 months
|
|
Nervous system disorders
Presyncope
|
0.53%
1/188 • Number of events 1 • 3 months
|
0.00%
0/189 • 3 months
|
0.00%
0/93 • 3 months
|
|
Nervous system disorders
Sciatica
|
0.53%
1/188 • Number of events 1 • 3 months
|
0.53%
1/189 • Number of events 1 • 3 months
|
0.00%
0/93 • 3 months
|
|
Nervous system disorders
Syncope
|
0.53%
1/188 • Number of events 1 • 3 months
|
0.00%
0/189 • 3 months
|
0.00%
0/93 • 3 months
|
|
Psychiatric disorders
Alcoholism
|
0.53%
1/188 • Number of events 1 • 3 months
|
0.00%
0/189 • 3 months
|
0.00%
0/93 • 3 months
|
|
Psychiatric disorders
Anxiety
|
0.53%
1/188 • Number of events 1 • 3 months
|
0.00%
0/189 • 3 months
|
0.00%
0/93 • 3 months
|
|
Psychiatric disorders
Depression
|
1.1%
2/188 • Number of events 2 • 3 months
|
0.00%
0/189 • 3 months
|
0.00%
0/93 • 3 months
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/188 • 3 months
|
1.1%
2/189 • Number of events 4 • 3 months
|
0.00%
0/93 • 3 months
|
|
Renal and urinary disorders
Renal cyst
|
0.00%
0/188 • 3 months
|
0.53%
1/189 • Number of events 1 • 3 months
|
0.00%
0/93 • 3 months
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/188 • 3 months
|
0.00%
0/189 • 3 months
|
1.1%
1/93 • Number of events 2 • 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.1%
2/188 • Number of events 2 • 3 months
|
0.00%
0/189 • 3 months
|
0.00%
0/93 • 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/188 • 3 months
|
0.53%
1/189 • Number of events 1 • 3 months
|
0.00%
0/93 • 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal ulcer
|
0.53%
1/188 • Number of events 1 • 3 months
|
0.00%
0/189 • 3 months
|
0.00%
0/93 • 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/188 • 3 months
|
0.53%
1/189 • Number of events 1 • 3 months
|
0.00%
0/93 • 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertention
|
0.53%
1/188 • Number of events 1 • 3 months
|
0.00%
0/189 • 3 months
|
0.00%
0/93 • 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/188 • 3 months
|
0.53%
1/189 • Number of events 1 • 3 months
|
0.00%
0/93 • 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/188 • 3 months
|
0.00%
0/189 • 3 months
|
1.1%
1/93 • Number of events 1 • 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.53%
1/188 • Number of events 1 • 3 months
|
0.00%
0/189 • 3 months
|
0.00%
0/93 • 3 months
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
0.53%
1/188 • Number of events 2 • 3 months
|
0.00%
0/189 • 3 months
|
1.1%
1/93 • Number of events 1 • 3 months
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.53%
1/188 • Number of events 1 • 3 months
|
0.00%
0/189 • 3 months
|
0.00%
0/93 • 3 months
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/188 • 3 months
|
0.53%
1/189 • Number of events 1 • 3 months
|
0.00%
0/93 • 3 months
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/188 • 3 months
|
0.53%
1/189 • Number of events 1 • 3 months
|
0.00%
0/93 • 3 months
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
1.1%
2/188 • Number of events 3 • 3 months
|
0.53%
1/189 • Number of events 1 • 3 months
|
0.00%
0/93 • 3 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/188 • 3 months
|
0.53%
1/189 • Number of events 1 • 3 months
|
0.00%
0/93 • 3 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/188 • 3 months
|
0.00%
0/189 • 3 months
|
1.1%
1/93 • Number of events 1 • 3 months
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
0.53%
1/188 • Number of events 1 • 3 months
|
0.00%
0/189 • 3 months
|
0.00%
0/93 • 3 months
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
0.53%
1/188 • Number of events 1 • 3 months
|
0.53%
1/189 • Number of events 1 • 3 months
|
0.00%
0/93 • 3 months
|
|
Skin and subcutaneous tissue disorders
Sunburn
|
0.53%
1/188 • Number of events 1 • 3 months
|
0.00%
0/189 • 3 months
|
0.00%
0/93 • 3 months
|
|
Surgical and medical procedures
Anal fissure excision
|
0.53%
1/188 • Number of events 1 • 3 months
|
0.00%
0/189 • 3 months
|
0.00%
0/93 • 3 months
|
|
Surgical and medical procedures
Angioplasty
|
0.00%
0/188 • 3 months
|
0.00%
0/189 • 3 months
|
1.1%
1/93 • Number of events 1 • 3 months
|
|
Surgical and medical procedures
Malignant tumour excision
|
0.53%
1/188 • Number of events 1 • 3 months
|
0.00%
0/189 • 3 months
|
0.00%
0/93 • 3 months
|
|
Surgical and medical procedures
Skin neoplasm excision
|
0.00%
0/188 • 3 months
|
0.53%
1/189 • Number of events 1 • 3 months
|
0.00%
0/93 • 3 months
|
|
Vascular disorders
Hypertention
|
0.53%
1/188 • Number of events 1 • 3 months
|
0.00%
0/189 • 3 months
|
0.00%
0/93 • 3 months
|
Additional Information
Senior Director, 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