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A Study to Evaluate the Safety and Clinical Study of Azelaic Acid Gel 15% in Patients With Moderate Facial Rosacea

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02120924
Recruitment Status : Completed
First Posted : April 23, 2014
Results First Posted : June 2, 2020
Last Update Posted : June 2, 2020
Sponsor:
Information provided by (Responsible Party):
Actavis Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Rosacea
Interventions Drug: Azelaic acid
Drug: Vehicle
Drug: Finacea
Enrollment 1009
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Azelaic Acid, 15% Topical Gel Finacea® (Azelaic Acid) Gel, 15% (Intendis) Gel Vehicle
Hide Arm/Group Description

Test product: Azelaic Acid, 15% topical gel (Watson Laboratories, Inc.)

Azelaic acid: Dosage form: Topical gel Dosage: Apply gel to the affected areas of the face twice daily for 12 weeks. The amount needed depends upon the size of the lesion site. Assure that enough is applied to adequately cover each lesion. Normally 0.5 g of gel is used on each 5 cm x 5 cm lesion site.

Reference product: Finacea® (azelaic acid) Gel, 15% (Intendis)

Azelaic acid: Dosage form: Topical gel Dosage: Apply gel to the affected areas of the face twice daily for 12 weeks. The amount needed depends upon the size of the lesion site. Assure that enough 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 product: Gel Vehicle of the test product (Watson Laboratories, Inc.)

Azelaic acid: Dosage form: Topical gel Dosage: Apply gel to the affected areas of the face twice daily for 12 weeks. The amount needed depends upon the size of the lesion site. Assure that enough is applied to adequately cover each lesion. Normally 0.5 g of gel is used on each 5 cm x 5 cm lesion site.

Period Title: Overall Study
Started 404 403 202
Completed 362 357 173
Not Completed 42 46 29
Reason Not Completed
Lack of Efficacy             1             2             3
Adverse Event             0             1             3
Withdrawal by Subject             16             20             8
Lost to Follow-up             14             14             11
Pregnancy             2             0             0
Protocol Violation             3             7             2
Physician Decision             0             1             1
Death             1             0             0
Compliance with IP             5             1             1
Arm/Group Title Azelaic Acid, 15% Topical Gel Finacea® (Azelaic Acid) Gel, 15% Gel Vehicle Total
Hide Arm/Group Description

Test product: Azelaic Acid, 15% topical gel (Watson Laboratories, Inc.)

Azelaic acid: Dosage form: Topical gel Dosage: Apply gel to the affected areas of the face twice daily for 12 weeks. The amount needed depends upon the size of the lesion site. Assure that enough is applied to adequately cover each lesion. Normally 0.5 g of gel is used on each 5 cm x 5 cm lesion site.

Reference product: Finacea® (azelaic acid) Gel, 15% (Intendis)

Azelaic acid: Dosage form: Topical gel Dosage: Apply gel to the affected areas of the face twice daily for 12 weeks. The amount needed depends upon the size of the lesion site. Assure that enough 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 product: Gel Vehicle of the test product (Watson Laboratories, Inc.)

Azelaic acid: Dosage form: Topical gel Dosage: Apply gel to the affected areas of the face twice daily for 12 weeks. The amount needed depends upon the size of the lesion site. Assure that enough is applied to adequately cover each lesion. Normally 0.5 g of gel is used on each 5 cm x 5 cm lesion site.

Total of all reporting groups
Overall Number of Baseline Participants 293 274 127 694
Hide Baseline Analysis Population Description
Summary of Demographic characteristics in PP Population
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 293 participants 274 participants 127 participants 694 participants
51.4  (12.71) 50.0  (12.42) 51.4  (11.73) 50.8  (12.42)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 293 participants 274 participants 127 participants 694 participants
Female
195
  66.6%
195
  71.2%
89
  70.1%
479
  69.0%
Male
98
  33.4%
79
  28.8%
38
  29.9%
215
  31.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 293 participants 274 participants 127 participants 694 participants
Hispanic or Latino
118
  40.3%
126
  46.0%
59
  46.5%
303
  43.7%
Not Hispanic or Latino
175
  59.7%
148
  54.0%
68
  53.5%
391
  56.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 293 participants 274 participants 127 participants 694 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
3
   1.0%
2
   0.7%
1
   0.8%
6
   0.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
1
   0.4%
0
   0.0%
1
   0.1%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
White
280
  95.6%
263
  96.0%
124
  97.6%
667
  96.1%
More than one race
10
   3.4%
8
   2.9%
2
   1.6%
20
   2.9%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Percent Change From Baseline to Week 12 in the Inflammatory (Papules and Pustules) Lesion Counts.
Hide Description Percent change from baseline to Week 12 in the inflammatory (papules and pustules) lesion counts in PP population.
Time Frame Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol population
Arm/Group Title Azelaic Acid, 15% Topical Gel Finacea® (Azelaic Acid) Gel, 15% Gel Vehicle
Hide Arm/Group Description:

Test product: Azelaic Acid, 15% topical gel (Watson Laboratories, Inc.)

Azelaic acid: Dosage form: Topical gel Dosage: Apply gel to the affected areas of the face twice daily for 12 weeks. The amount needed depends upon the size of the lesion site. Assure that enough is applied to adequately cover each lesion. Normally 0.5 g of gel is used on each 5 cm x 5 cm lesion site.

Reference product: Finacea® (azelaic acid) Gel, 15% (Intendis)

Azelaic acid: Dosage form: Topical gel Dosage: Apply gel to the affected areas of the face twice daily for 12 weeks. The amount needed depends upon the size of the lesion site. Assure that enough 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 product (Watson Laboratories, Inc.)

Azelaic acid: Dosage form: Topical gel Dosage: Apply gel to the affected areas of the face twice daily for 12 weeks. The amount needed depends upon the size of the lesion site. Assure that enough is applied to adequately cover each lesion. Normally 0.5 g of gel is used on each 5 cm x 5 cm lesion site.

Overall Number of Participants Analyzed 293 274 127
Mean (Standard Deviation)
Unit of Measure: Percent change in lesion counts
-66.96  (29.394) -68.62  (27.415) -38.64  (46.845)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Azelaic Acid, 15% Topical Gel, Finacea® (Azelaic Acid) Gel, 15%
Comments The primary endpoint was the percent change from baseline to Week 12 in the inflammatory (papules and pustules) lesion counts in PP population.
Type of Statistical Test Equivalence
Comments Bioequivalence was established if the 90% CI for the ratio of Test/Reference means was contained within the interval [0.80, 1.25].
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.98
Confidence Interval (2-Sided) 90%
0.92 to 1.05
Estimation Comments Bioequivalence was established if the 90% CI for the ratio of Test/Reference means was contained within the interval [0.80, 1.25].
2.Secondary Outcome
Title The Percentage of Subjects With a Clinical Response of "Success" at Week 12 Using Investigator Global Evaluation (IGE)
Hide Description

The secondary endpoint is the clinical response of "success" or "failure" at Week 12 on the IGE. Success is defined as an IGE score of 0 (clear) or 1 (almost clear). Any subject who is not considered to be a success will be considered to be a failure.

Score-Grade-Definition 0 - Clear - No inflammatory lesions present; at most, mild erythema.

  1. - Almost Clear - Very mild erythema present. Very few small papules/pustules.
  2. - Mild - Mild erythema. Several small papules/pustules.
  3. - Moderate - Moderate erythema. Several small or large papules/pustules, and up to two nodules.
  4. - Severe - Severe erythema. Numerous small and/or large papules/pustules, up to several nodules.
Time Frame Baseline to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis of Treatment Success Based on IGE Score at Week 12 in PP Population.
Arm/Group Title Azelaic Acid, 15% Topical Gel Finacea® (Azelaic Acid) Gel, 15% Gel Vehicle
Hide Arm/Group Description:

Test product: Azelaic Acid, 15% topical gel (Watson Laboratories, Inc.)

Azelaic acid: Dosage form: Topical gel Dosage: Apply gel to the affected areas of the face twice daily for 12 weeks. The amount needed depends upon the size of the lesion site. Assure that enough is applied to adequately cover each lesion. Normally 0.5 g of gel is used on each 5 cm x 5 cm lesion site.

Reference product: Finacea® (azelaic acid) Gel, 15% (Intendis)

Azelaic acid: Dosage form: Topical gel Dosage: Apply gel to the affected areas of the face twice daily for 12 weeks. The amount needed depends upon the size of the lesion site. Assure that enough 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 product: Gel Vehicle of the test product (Watson Laboratories, Inc.)

Azelaic acid: Dosage form: Topical gel Dosage: Apply gel to the affected areas of the face twice daily for 12 weeks. The amount needed depends upon the size of the lesion site. Assure that enough is applied to adequately cover each lesion. Normally 0.5 g of gel is used on each 5 cm x 5 cm lesion site.

Overall Number of Participants Analyzed 293 274 127
Measure Type: Count of Participants
Unit of Measure: Participants
Success
138
  47.1%
117
  42.7%
40
  31.5%
Failure
155
  52.9%
157
  57.3%
87
  68.5%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Azelaic Acid, 15% Topical Gel, Finacea® (Azelaic Acid) Gel, 15%
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments A two-sided, continuity-corrected, 90% CI on the Test-to-Reference difference for the proportion of subjects with treatment success on the IGE was constructed.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.044
Confidence Interval (2-Sided) 90%
-0.028 to 0.116
Estimation Comments Bioequivalence was established if the 90% CI for the difference was contained within the interval [-0.20, +0.20].
Time Frame Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Azelaic Acid, 15% Topical Gel Finacea® (Azelaic Acid) Gel, 15% Gel Vehicle
Hide Arm/Group Description

Test product: Azelaic Acid, 15% topical gel (Watson Laboratories, Inc.)

Azelaic acid: Dosage form: Topical gel Dosage: Apply gel to the affected areas of the face twice daily for 12 weeks. The amount needed depends upon the size of the lesion site. Assure that enough is applied to adequately cover each lesion. Normally 0.5 g of gel is used on each 5 cm x 5 cm lesion site.

Reference product: Finacea® (azelaic acid) Gel, 15% (Intendis)

Azelaic acid: Dosage form: Topical gel Dosage: Apply gel to the affected areas of the face twice daily for 12 weeks. The amount needed depends upon the size of the lesion site. Assure that enough 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 product: Gel Vehicle of the test product (Watson Laboratories, Inc.)

Azelaic acid: Dosage form: Topical gel Dosage: Apply gel to the affected areas of the face twice daily for 12 weeks. The amount needed depends upon the size of the lesion site. Assure that enough is applied to adequately cover each lesion. Normally 0.5 g of gel is used on each 5 cm x 5 cm lesion site.

All-Cause Mortality
Azelaic Acid, 15% Topical Gel Finacea® (Azelaic Acid) Gel, 15% Gel Vehicle
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/390 (0.26%)   0/386 (0.00%)   0/190 (0.00%) 
Hide Serious Adverse Events
Azelaic Acid, 15% Topical Gel Finacea® (Azelaic Acid) Gel, 15% Gel Vehicle
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/390 (0.26%)   0/386 (0.00%)   0/190 (0.00%) 
Cardiac disorders       
Cardiac failure congestive  1  1/390 (0.26%)  0/386 (0.00%)  0/190 (0.00%) 
1
Term from vocabulary, MedDRA (16.0)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Azelaic Acid, 15% Topical Gel Finacea® (Azelaic Acid) Gel, 15% Gel Vehicle
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   109/390 (27.95%)   98/386 (25.39%)   47/190 (24.74%) 
Blood and lymphatic system disorders       
Anaemia  1  0/390 (0.00%)  1/386 (0.26%)  0/190 (0.00%) 
Cardiac disorders       
Cardiac failure congestive  1  1/390 (0.26%)  0/386 (0.00%)  0/190 (0.00%) 
Ear and labyrinth disorders       
Ear pain  1  1/390 (0.26%)  0/386 (0.00%)  1/190 (0.53%) 
Vertigo  1  1/390 (0.26%)  0/386 (0.00%)  0/190 (0.00%) 
Endocrine disorders       
Hypothyroidism  1  0/390 (0.00%)  0/386 (0.00%)  1/190 (0.53%) 
Eye disorders       
Blepharospasm  1  1/390 (0.26%)  0/386 (0.00%)  0/190 (0.00%) 
Eye irritation  1  1/390 (0.26%)  0/386 (0.00%)  0/190 (0.00%) 
Eye pain  1  1/390 (0.26%)  0/386 (0.00%)  0/190 (0.00%) 
Eye pruritus  1  0/390 (0.00%)  1/386 (0.26%)  0/190 (0.00%) 
Foreign body sensation in eye  1  1/390 (0.26%)  0/386 (0.00%)  0/190 (0.00%) 
Lacrimation increased  1  1/390 (0.26%)  1/386 (0.26%)  0/190 (0.00%) 
Vision blurred  1  1/390 (0.26%)  0/386 (0.00%)  0/190 (0.00%) 
Gastrointestinal disorders       
Abdominal discomfort  1  0/390 (0.00%)  0/386 (0.00%)  2/190 (1.05%) 
Abdominal pain  1  1/390 (0.26%)  1/386 (0.26%)  0/190 (0.00%) 
Abdominal pain lower  1  1/390 (0.26%)  0/386 (0.00%)  1/190 (0.53%) 
Abdominal pain upper  1  3/390 (0.77%)  3/386 (0.78%)  0/190 (0.00%) 
Aphthous stomatitis  1  0/390 (0.00%)  1/386 (0.26%)  0/190 (0.00%) 
Diarrhoea  1  2/390 (0.51%)  5/386 (1.30%)  2/190 (1.05%) 
Dyspepsia  1  1/390 (0.26%)  5/386 (1.30%)  0/190 (0.00%) 
Gastroesophageal reflux disease  1  1/390 (0.26%)  1/386 (0.26%)  1/190 (0.53%) 
Haemorrhoids  1  0/390 (0.00%)  1/386 (0.26%)  1/190 (0.53%) 
Mouth ulceration  1  1/390 (0.26%)  0/386 (0.00%)  0/190 (0.00%) 
Nausea  1  5/390 (1.28%)  1/386 (0.26%)  0/190 (0.00%) 
Tooth crowding  1  1/390 (0.26%)  0/386 (0.00%)  0/190 (0.00%) 
Toothache  1  0/390 (0.00%)  2/386 (0.52%)  1/190 (0.53%) 
Vomiting  1  1/390 (0.26%)  4/386 (1.04%)  0/190 (0.00%) 
General disorders       
Adverse drug reaction  1  0/390 (0.00%)  0/386 (0.00%)  1/190 (0.53%) 
Application site pain  1  2/390 (0.51%)  1/386 (0.26%)  1/190 (0.53%) 
Application site pruritus  1  1/390 (0.26%)  0/386 (0.00%)  0/190 (0.00%) 
Chills  1  0/390 (0.00%)  1/386 (0.26%)  1/190 (0.53%) 
Fatigue  1  2/390 (0.51%)  2/386 (0.52%)  0/190 (0.00%) 
Feeling hot  1  1/390 (0.26%)  0/386 (0.00%)  0/190 (0.00%) 
Influenza like illness  1  0/390 (0.00%)  3/386 (0.78%)  1/190 (0.53%) 
Local swelling  1  1/390 (0.26%)  0/386 (0.00%)  0/190 (0.00%) 
Malaise  1  0/390 (0.00%)  1/386 (0.26%)  0/190 (0.00%) 
Pain  1  2/390 (0.51%)  3/386 (0.78%)  1/190 (0.53%) 
Pyrexia  1  2/390 (0.51%)  0/386 (0.00%)  0/190 (0.00%) 
Hepatobiliary disorders       
Biliary colic  1  1/390 (0.26%)  0/386 (0.00%)  0/190 (0.00%) 
Cholelithiasis  1  1/390 (0.26%)  0/386 (0.00%)  0/190 (0.00%) 
Immune system disorders       
Hypersensitivity  1  1/390 (0.26%)  0/386 (0.00%)  1/190 (0.53%) 
Seasonal allergy  1  0/390 (0.00%)  1/386 (0.26%)  0/190 (0.00%) 
Infections and infestations       
Acute sinusitis  1  1/390 (0.26%)  0/386 (0.00%)  0/190 (0.00%) 
Alveolar osteitis  1  0/390 (0.00%)  1/386 (0.26%)  0/190 (0.00%) 
Atypical pnuemonia  1  0/390 (0.00%)  0/386 (0.00%)  1/190 (0.53%) 
Bacterial infection  1  0/390 (0.00%)  1/386 (0.26%)  0/190 (0.00%) 
Bronchitis  1  0/390 (0.00%)  3/386 (0.78%)  1/190 (0.53%) 
Cellulitis  1  0/390 (0.00%)  0/386 (0.00%)  1/190 (0.53%) 
Conjunctivitis bacterial  1  1/390 (0.26%)  0/386 (0.00%)  0/190 (0.00%) 
Conjunctivitis infective  1  0/390 (0.00%)  1/386 (0.26%)  0/190 (0.00%) 
Ear infection  1  2/390 (0.51%)  0/386 (0.00%)  0/190 (0.00%) 
Eye infection  1  0/390 (0.00%)  1/386 (0.26%)  0/190 (0.00%) 
Fungal infection  1  0/390 (0.00%)  1/386 (0.26%)  0/190 (0.00%) 
Gastroenteritis  1  0/390 (0.00%)  1/386 (0.26%)  0/190 (0.00%) 
Gastroenteritis viral  1  0/390 (0.00%)  3/386 (0.78%)  0/190 (0.00%) 
Herpes simplex  1  0/390 (0.00%)  1/386 (0.26%)  0/190 (0.00%) 
Hordeolum  1  0/390 (0.00%)  1/386 (0.26%)  0/190 (0.00%) 
Influenza  1  6/390 (1.54%)  4/386 (1.04%)  1/190 (0.53%) 
Kidney infection  1  0/390 (0.00%)  1/386 (0.26%)  0/190 (0.00%) 
Lyme disease  1  0/390 (0.00%)  0/386 (0.00%)  1/190 (0.53%) 
Nasopharyngitis  1  27/390 (6.92%)  19/386 (4.92%)  9/190 (4.74%) 
Oral herpes  1  0/390 (0.00%)  1/386 (0.26%)  0/190 (0.00%) 
Pertussis  1  1/390 (0.26%)  1/386 (0.26%)  0/190 (0.00%) 
Pharyngitis  1  0/390 (0.00%)  1/386 (0.26%)  0/190 (0.00%) 
Pharyngitis streptococcal  1  1/390 (0.26%)  0/386 (0.00%)  0/190 (0.00%) 
Sinusitis  1  6/390 (1.54%)  7/386 (1.81%)  1/190 (0.53%) 
Skin infection  1  0/390 (0.00%)  0/386 (0.00%)  1/190 (0.53%) 
Subcutaneous abscess  1  1/390 (0.26%)  0/386 (0.00%)  0/190 (0.00%) 
Tonsillitus  1  0/390 (0.00%)  1/386 (0.26%)  0/190 (0.00%) 
Tooth abscess  1  0/390 (0.00%)  0/386 (0.00%)  1/190 (0.53%) 
Upper respiratory tract infection  1  3/390 (0.77%)  5/386 (1.30%)  3/190 (1.58%) 
Urinary tract infection  1  0/390 (0.00%)  1/386 (0.26%)  0/190 (0.00%) 
Injury, poisoning and procedural complications       
Foot fracture  1  0/390 (0.00%)  1/386 (0.26%)  0/190 (0.00%) 
Foreign body  1  1/390 (0.26%)  0/386 (0.00%)  0/190 (0.00%) 
Post procedural complication  1  0/390 (0.00%)  1/386 (0.26%)  0/190 (0.00%) 
Spinal column injury  1  1/390 (0.26%)  0/386 (0.00%)  0/190 (0.00%) 
Sunburn  1  0/390 (0.00%)  1/386 (0.26%)  0/190 (0.00%) 
Investigations       
Blood cholesterol increased  1  0/390 (0.00%)  1/386 (0.26%)  0/190 (0.00%) 
Heart rate increased  1  0/390 (0.00%)  1/386 (0.26%)  0/190 (0.00%) 
Metabolism and nutrition disorders       
Hypercholesterolaemia  1  1/390 (0.26%)  0/386 (0.00%)  0/190 (0.00%) 
Vitamin D deficiency  1  1/390 (0.26%)  0/386 (0.00%)  0/190 (0.00%) 
Musculoskeletal and connective tissue disorders       
Arthralgia  1  2/390 (0.51%)  1/386 (0.26%)  1/190 (0.53%) 
Back pain  1  4/390 (1.03%)  5/386 (1.30%)  0/190 (0.00%) 
Invertebral disc protrusion  1  1/390 (0.26%)  0/386 (0.00%)  0/190 (0.00%) 
Muscle spasms  1  0/390 (0.00%)  1/386 (0.26%)  2/190 (1.05%) 
Muscoloskeletal pain  1  1/390 (0.26%)  0/386 (0.00%)  0/190 (0.00%) 
Myalgia  1  2/390 (0.51%)  1/386 (0.26%)  0/190 (0.00%) 
Osteoarthritis  1  1/390 (0.26%)  0/386 (0.00%)  0/190 (0.00%) 
Rotator cuff syndrome  1  0/390 (0.00%)  1/386 (0.26%)  0/190 (0.00%) 
Nervous system disorders       
Burning sensation  1  4/390 (1.03%)  5/386 (1.30%)  0/190 (0.00%) 
Dizziness  1  1/390 (0.26%)  0/386 (0.00%)  0/190 (0.00%) 
Dizziness exertional  1  0/390 (0.00%)  1/386 (0.26%)  0/190 (0.00%) 
Headache  1  23/390 (5.90%)  23/386 (5.96%)  11/190 (5.79%) 
Migraine  1  3/390 (0.77%)  2/386 (0.52%)  3/190 (1.58%) 
Nerve compression  1  0/390 (0.00%)  1/386 (0.26%)  0/190 (0.00%) 
Neuropathy peripheral  1  0/390 (0.00%)  1/386 (0.26%)  0/190 (0.00%) 
Paraesthesia  1  0/390 (0.00%)  1/386 (0.26%)  0/190 (0.00%) 
Sinus headache  1  0/390 (0.00%)  1/386 (0.26%)  1/190 (0.53%) 
Tension headache  1  0/390 (0.00%)  1/386 (0.26%)  0/190 (0.00%) 
Transient ischaemic attack  1  1/390 (0.26%)  0/386 (0.00%)  0/190 (0.00%) 
Psychiatric disorders       
Anxiety  1  1/390 (0.26%)  1/386 (0.26%)  0/190 (0.00%) 
Renal and urinary disorders       
Hypertonic bladder  1  0/390 (0.00%)  1/386 (0.26%)  0/190 (0.00%) 
Nephrolithiasis  1  1/390 (0.26%)  0/386 (0.00%)  0/190 (0.00%) 
Reproductive system and breast disorders       
Dysmenorrhoea  1  6/390 (1.54%)  2/386 (0.52%)  2/190 (1.05%) 
Premenstrual headache  1  0/390 (0.00%)  1/386 (0.26%)  0/190 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Allergic sinusitis  1  0/390 (0.00%)  1/386 (0.26%)  0/190 (0.00%) 
Asthma  1  0/390 (0.00%)  1/386 (0.26%)  0/190 (0.00%) 
Cough  1  2/390 (0.51%)  2/386 (0.52%)  2/190 (1.05%) 
Epistaxis  1  0/390 (0.00%)  0/386 (0.00%)  1/190 (0.53%) 
Nasal congestion  1  1/390 (0.26%)  2/386 (0.52%)  1/190 (0.53%) 
Oropharyngeal pain  1  3/390 (0.77%)  5/386 (1.30%)  0/190 (0.00%) 
Respiratory tract congestion  1  3/390 (0.77%)  2/386 (0.52%)  0/190 (0.00%) 
Rhinitis allergic  1  0/390 (0.00%)  1/386 (0.26%)  0/190 (0.00%) 
Rhinorrhoea  1  1/390 (0.26%)  1/386 (0.26%)  3/190 (1.58%) 
Sinus congestion  1  5/390 (1.28%)  2/386 (0.52%)  0/190 (0.00%) 
Sneezing  1  0/390 (0.00%)  1/386 (0.26%)  0/190 (0.00%) 
Skin and subcutaneous tissue disorders       
Acne  1  0/390 (0.00%)  1/386 (0.26%)  0/190 (0.00%) 
Blister  1  0/390 (0.00%)  2/386 (0.52%)  0/190 (0.00%) 
Dermal cyst  1  0/390 (0.00%)  1/386 (0.26%)  0/190 (0.00%) 
Dry skin  1  2/390 (0.51%)  2/386 (0.52%)  2/190 (1.05%) 
Erythema  1  5/390 (1.28%)  4/386 (1.04%)  4/190 (2.11%) 
Pain of skin  1  0/390 (0.00%)  1/386 (0.26%)  0/190 (0.00%) 
Pruritus  1  6/390 (1.54%)  3/386 (0.78%)  2/190 (1.05%) 
Rash  1  0/390 (0.00%)  4/386 (1.04%)  0/190 (0.00%) 
Rosacea  1  0/390 (0.00%)  0/386 (0.00%)  4/190 (2.11%) 
Skin burning sensation  1  1/390 (0.26%)  2/386 (0.52%)  0/190 (0.00%) 
Skin exfoliation  1  0/390 (0.00%)  1/386 (0.26%)  1/190 (0.53%) 
Skin irritation  1  2/390 (0.51%)  0/386 (0.00%)  0/190 (0.00%) 
Urticaria  1  1/390 (0.26%)  1/386 (0.26%)  1/190 (0.53%) 
1
Term from vocabulary, MedDRA (16.0)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Director, CE Studies
Organization: Teva Pharmaceuticals USA, Inc.
Phone: 1-888-483-8279
EMail: USMedinfo@tevapharm.com
Layout table for additonal information
Responsible Party: Actavis Inc.
ClinicalTrials.gov Identifier: NCT02120924    
Other Study ID Numbers: 13-1014
First Submitted: April 21, 2014
First Posted: April 23, 2014
Results First Submitted: April 9, 2020
Results First Posted: June 2, 2020
Last Update Posted: June 2, 2020