Trial of Clindamycin / Benzoyl Peroxide Gel in Subjects With Acne

This study has been completed.
Sponsor:
Collaborators:
RHO CRO
Quintiles CRO
GlaxoSmithKline
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00776919
First received: October 21, 2008
Last updated: February 9, 2012
Last verified: February 2012
Results First Received: December 21, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Acne Vulgaris
Interventions: Drug: clindamycin / benzoyl peroxide gel
Drug: clindamycin gel
Drug: BPO gel
Drug: vehicle gel

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Duac Low-dose (LD) Gel Duac LD gel (combination of 1% clindamycin phosphate and 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
Clindamycin Gel Clindamycin gel (containing 1% clindamycin phosphate) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
BPO Gel Benzoyl peroxide (BPO) gel (containing 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
Vehicle Gel Matching vehicle gel without the active ingredients clinidamycin phosphate and benzoyl peroxide, applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks

Participant Flow:   Overall Study
    Duac Low-dose (LD) Gel     Clindamycin Gel     BPO Gel     Vehicle Gel  
STARTED     327     328     328     332  
COMPLETED     300     295     296     293  
NOT COMPLETED     27     33     32     39  
Withdrawal by Subject                 16                 14                 15                 26  
Lost to Follow-up                 8                 12                 11                 8  
Adverse Event                 1                 0                 2                 2  
Protocol Violation                 1                 2                 0                 1  
Other: Lack of Efficacy/Lost Medication                 1                 5                 4                 2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Duac Low-dose (LD) Gel Duac LD gel (combination of 1% clindamycin phosphate and 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
Clindamycin Gel Clindamycin gel (containing 1% clindamycin phosphate) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
BPO Gel Benzoyl peroxide (BPO) gel (containing 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
Vehicle Gel Matching vehicle gel without the active ingredients clinidamycin phosphate and benzoyl peroxide, applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
Total Total of all reporting groups

Baseline Measures
    Duac Low-dose (LD) Gel     Clindamycin Gel     BPO Gel     Vehicle Gel     Total  
Number of Participants  
[units: participants]
  327     328     328     332     1315  
Age  
[units: Years]
Mean ± Standard Deviation
  20.0  ± 7.0     20.2  ± 6.9     20.6  ± 7.1     20.7  ± 7.4     20.4  ± 7.1  
Gender  
[units: Participants]
         
Female     202     180     203     210     795  
Male     125     148     125     122     520  
Race/Ethnicity, Customized  
[units: participants]
         
White     259     274     251     258     1042  
Black     47     37     54     54     192  
Asian     13     9     17     16     55  
Multiracial     5     7     7     4     23  
American Indian or Alaska Native     3     1     0     0     4  



  Outcome Measures
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1.  Primary:   Number of Participants With Improvement of at Least 2 Grades in the Investigator's Static Global Assessment (ISGA) Score From Baseline to Week 12   [ Time Frame: Baseline (Day 1) and Week 12 ]

2.  Primary:   Mean Change From Baseline (BL) to Week 12 in Inflammatory Lesion Counts   [ Time Frame: Baseline (Day 1) and Week 12 ]

3.  Primary:   Mean Change From Baseline to Week 12 in Non-inflammatory Lesion Counts   [ Time Frame: Baseline (Day 1) and Week 12 ]

4.  Primary:   Mean Change From Baseline to Week 12 in Total Lesion Counts   [ Time Frame: Baseline (Day 1) and Week 12 ]

5.  Secondary:   Mean Percent Change From Baseline to Week 12 in Lesion Counts (Total, Inflammatory, and Non-inflammatory)   [ Time Frame: Baseline (Day 1) and Week 12 ]

6.  Secondary:   Number of Participants Who Had a Subject Global Assessment (SGA) Score of 0 or 1 at Week 12   [ Time Frame: Week 12 ]

7.  Secondary:   Number of Participants Who Had an ISGA Score of 0 or 1 at Week 12   [ Time Frame: Week 12 ]

8.  Secondary:   Mean Change From Baseline to Week 12 in Systolic and Diastolic Blood Pressure   [ Time Frame: Baseline (Day 1) and Week 12 ]

9.  Secondary:   Mean Change From Baseline to Week 12 in Temperature   [ Time Frame: Baseline (Day 1) and Week 12 ]

10.  Secondary:   Mean Change From Baseline to Week 12 in Pulse Rate   [ Time Frame: Baseline (Day 1) and Week 12 ]

11.  Secondary:   Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Erythema, Dryness, and Peeling   [ Time Frame: Baseline; Weeks 2, 4, 8, and 12 ]

12.  Secondary:   Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Itching and Burning/Stinging   [ Time Frame: Baseline; Weeks 2, 4, 8, and 12 ]

13.  Secondary:   Mean Duration of Study Product Use   [ Time Frame: Baseline (Day 1) through Week 12 ]

14.  Secondary:   Number of Participants Reporting the Indicated Treatment-emergent Adverse Events (AEs) Resulting in Study Product Discontinuation   [ Time Frame: Baseline (Day 1) through Week 12 ]


  Serious Adverse Events


  Other Adverse Events
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Time Frame No text entered.
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   0%  

Reporting Groups
  Description
Duac Low-dose (LD) Gel Duac LD gel (combination of 1% clindamycin phosphate and 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
Clindamycin Gel Clindamycin gel (containing 1% clindamycin phosphate) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
BPO Gel Benzoyl peroxide (BPO) gel (containing 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
Vehicle Gel Matching vehicle gel without the active ingredients clinidamycin phosphate and benzoyl peroxide, applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks

Other Adverse Events
    Duac Low-dose (LD) Gel     Clindamycin Gel     BPO Gel     Vehicle Gel  
Total, other (not including serious) adverse events          
# participants affected / at risk     72/327     83/328     102/328     87/332  
Blood and lymphatic system disorders          
Iron Deficiency Anemia † 1        
# participants affected / at risk     1/327 (0.31%)     0/328 (0.00%)     0/328 (0.00%)     0/332 (0.00%)  
Lymphadenopathy † 1        
# participants affected / at risk     0/327 (0.00%)     1/328 (0.30%)     0/328 (0.00%)     1/332 (0.30%)  
Ear and labyrinth disorders          
Ear Congestion † 1        
# participants affected / at risk     1/327 (0.31%)     0/328 (0.00%)     0/328 (0.00%)     0/332 (0.00%)  
Ear Pain † 1        
# participants affected / at risk     0/327 (0.00%)     0/328 (0.00%)     0/328 (0.00%)     1/332 (0.30%)  
Eye disorders          
Blepharospasm † 1        
# participants affected / at risk     0/327 (0.00%)     0/328 (0.00%)     0/328 (0.00%)     1/332 (0.30%)  
Conjunctivitis † 1        
# participants affected / at risk     1/327 (0.31%)     0/328 (0.00%)     0/328 (0.00%)     0/332 (0.00%)  
Keratoconus † 1        
# participants affected / at risk     0/327 (0.00%)     0/328 (0.00%)     0/328 (0.00%)     1/332 (0.30%)  
Gastrointestinal disorders          
Abdominal Discomfort † 1        
# participants affected / at risk     0/327 (0.00%)     0/328 (0.00%)     0/328 (0.00%)     1/332 (0.30%)  
Abdominal Hernia † 1        
# participants affected / at risk     0/327 (0.00%)     0/328 (0.00%)     0/328 (0.00%)     1/332 (0.30%)  
Abdominal Pain Upper † 1        
# participants affected / at risk     1/327 (0.31%)     2/328 (0.61%)     1/328 (0.30%)     1/332 (0.30%)  
Cheilitis † 1        
# participants affected / at risk     0/327 (0.00%)     0/328 (0.00%)     0/328 (0.00%)     1/332 (0.30%)  
Dental Caries † 1        
# participants affected / at risk     1/327 (0.31%)     0/328 (0.00%)     0/328 (0.00%)     1/332 (0.30%)  
Diarrhea † 1        
# participants affected / at risk     0/327 (0.00%)     2/328 (0.61%)     0/328 (0.00%)     0/332 (0.00%)  
Dyspepsia † 1        
# participants affected / at risk     1/327 (0.31%)     0/328 (0.00%)     0/328 (0.00%)     1/332 (0.30%)  
Gastritis † 1        
# participants affected / at risk     1/327 (0.31%)     0/328 (0.00%)     1/328 (0.30%)     0/332 (0.00%)  
Gastroesophageal Reflux Disease † 1        
# participants affected / at risk     0/327 (0.00%)     0/328 (0.00%)     0/328 (0.00%)     1/332 (0.30%)  
Hiatus Hernia † 1        
# participants affected / at risk     0/327 (0.00%)     0/328 (0.00%)     0/328 (0.00%)     1/332 (0.30%)  
Nausea † 1        
# participants affected / at risk     0/327 (0.00%)     2/328 (0.61%)     0/328 (0.00%)     0/332 (0.00%)  
Stomach Discomfort † 1        
# participants affected / at risk     2/327 (0.61%)     0/328 (0.00%)     0/328 (0.00%)     0/332 (0.00%)  
Toothache † 1        
# participants affected / at risk     1/327 (0.31%)     1/328 (0.30%)     1/328 (0.30%)     1/332 (0.30%)  
Vomiting † 1        
# participants affected / at risk     0/327 (0.00%)     1/328 (0.30%)     0/328 (0.00%)     1/332 (0.30%)  
Gastrointestinal Infection † 1        
# participants affected / at risk     1/327 (0.31%)     1/328 (0.30%)     2/328 (0.61%)     0/332 (0.00%)  
General disorders          
Application Site Dermatitis † 1        
# participants affected / at risk     2/327 (0.61%)     0/328 (0.00%)     0/328 (0.00%)     0/332 (0.00%)  
Application Site Dryness † 1        
# participants affected / at risk     0/327 (0.00%)     0/328 (0.00%)     1/328 (0.30%)     1/332 (0.30%)  
Application Site Eczema † 1        
# participants affected / at risk     0/327 (0.00%)     0/328 (0.00%)     1/328 (0.30%)     0/332 (0.00%)  
Application Site Erythema † 1        
# participants affected / at risk     0/327 (0.00%)     0/328 (0.00%)     1/328 (0.30%)     0/332 (0.00%)  
Application Site Hypersensitivity † 1        
# participants affected / at risk     0/327 (0.00%)     0/328 (0.00%)     1/328 (0.30%)     0/332 (0.00%)  
Application Site Irritation † 1        
# participants affected / at risk     1/327 (0.31%)     0/328 (0.00%)     2/328 (0.61%)     0/332 (0.00%)  
Application Site Pain † 1        
# participants affected / at risk     0/327 (0.00%)     1/328 (0.30%)     0/328 (0.00%)     0/332 (0.00%)  
Application Site Photosensitivity Reaction † 1        
# participants affected / at risk     2/327 (0.61%)     1/328 (0.30%)     1/328 (0.30%)     2/332 (0.60%)  
Application Site Pruritus † 1        
# participants affected / at risk     0/327 (0.00%)     1/328 (0.30%)     1/328 (0.30%)     1/332 (0.30%)  
Application Site Rash † 1        
# participants affected / at risk     0/327 (0.00%)     0/328 (0.00%)     1/328 (0.30%)     0/332 (0.00%)  
Drug Intolerance † 1        
# participants affected / at risk     0/327 (0.00%)     0/328 (0.00%)     1/328 (0.30%)     0/332 (0.00%)  
Influenza Like Illness † 1        
# participants affected / at risk     0/327 (0.00%)     1/328 (0.30%)     0/328 (0.00%)     1/332 (0.30%)  
Mass † 1        
# participants affected / at risk     1/327 (0.31%)     0/328 (0.00%)     0/328 (0.00%)     0/332 (0.00%)  
Pyrexia † 1        
# participants affected / at risk     1/327 (0.31%)     1/328 (0.30%)     0/328 (0.00%)     2/332 (0.60%)  
Hepatobiliary disorders          
Hepatic Cyst † 1        
# participants affected / at risk     0/327 (0.00%)     0/328 (0.00%)     0/328 (0.00%)     1/332 (0.30%)  
Immune system disorders          
Seasonal Allergy † 1        
# participants affected / at risk     0/327 (0.00%)     0/328 (0.00%)     2/328 (0.61%)     0/332 (0.00%)  
Infections and infestations          
Acarodermatitis † 1        
# participants affected / at risk     0/327 (0.00%)     0/328 (0.00%)     0/328 (0.00%)     1/332 (0.30%)  
Alveolar Osteitis † 1        
# participants affected / at risk     1/327 (0.31%)     0/328 (0.00%)     0/328 (0.00%)     0/332 (0.00%)  
Arthritis Infective † 1        
# participants affected / at risk     0/327 (0.00%)     1/328 (0.30%)     0/328 (0.00%)     0/332 (0.00%)  
Body Tinea † 1        
# participants affected / at risk     0/327 (0.00%)     0/328 (0.00%)     0/328 (0.00%)     1/332 (0.30%)  
Bronchitis † 1        
# participants affected / at risk     0/327 (0.00%)     2/328 (0.61%)     1/328 (0.30%)     1/332 (0.30%)  
Cellulitis † 1        
# participants affected / at risk     0/327 (0.00%)     1/328 (0.30%)     0/328 (0.00%)     0/332 (0.00%)  
Conjunctivitis Infective † 1        
# participants affected / at risk     0/327 (0.00%)     0/328 (0.00%)     0/328 (0.00%)     1/332 (0.30%)  
Ear Infection † 1        
# participants affected / at risk     1/327 (0.31%)     0/328 (0.00%)     2/328 (0.61%)     0/332 (0.00%)  
Folliculitis † 1        
# participants affected / at risk     1/327 (0.31%)     0/328 (0.00%)     0/328 (0.00%)     0/332 (0.00%)  
Fungal Infection † 1        
# participants affected / at risk     0/327 (0.00%)     0/328 (0.00%)     1/328 (0.30%)     0/332 (0.00%)  
Furuncle † 1        
# participants affected / at risk     0/327 (0.00%)     0/328 (0.00%)     1/328 (0.30%)     0/332 (0.00%)  
Gastroenteritis † 1        
# participants affected / at risk     1/327 (0.31%)     0/328 (0.00%)     0/328 (0.00%)     1/332 (0.30%)  
Gastroenteritis Viral † 1        
# participants affected / at risk     0/327 (0.00%)     0/328 (0.00%)     1/328 (0.30%)     2/332 (0.60%)  
Gingival Infection † 1        
# participants affected / at risk     0/327 (0.00%)     1/328 (0.30%)     0/328 (0.00%)     1/332 (0.30%)  
Herpes Zoster † 1        
# participants affected / at risk     1/327 (0.31%)     0/328 (0.00%)     0/328 (0.00%)     0/332 (0.00%)  
Impetigo † 1        
# participants affected / at risk     0/327 (0.00%)     1/328 (0.30%)     0/328 (0.00%)     0/332 (0.00%)  
Infectious Mononucleosis † 1        
# participants affected / at risk     0/327 (0.00%)     0/328 (0.00%)     0/328 (0.00%)     1/332 (0.30%)  
Influenza † 1        
# participants affected / at risk     3/327 (0.92%)     5/328 (1.52%)     1/328 (0.30%)     4/332 (1.20%)  
Laryngitis † 1        
# participants affected / at risk     0/327 (0.00%)     0/328 (0.00%)     1/328 (0.30%)     0/332 (0.00%)  
Lower Respiratory Tract Infection † 1        
# participants affected / at risk     0/327 (0.00%)     0/328 (0.00%)     1/328 (0.30%)     0/332 (0.00%)  
Nasopharyngitis † 1        
# participants affected / at risk     27/327 (8.26%)     23/328 (7.01%)     32/328 (9.76%)     19/332 (5.72%)  
Oral Candidiasis † 1        
# participants affected / at risk     1/327 (0.31%)     0/328 (0.00%)     0/328 (0.00%)     0/332 (0.00%)  
Otitis Externa † 1        
# participants affected / at risk     1/327 (0.31%)     0/328 (0.00%)     1/328 (0.30%)     0/332 (0.00%)  
Pharyngitis † 1        
# participants affected / at risk     0/327 (0.00%)     1/328 (0.30%)     2/328 (0.61%)     0/332 (0.00%)  
Pharyngitis Streptococcal † 1        
# participants affected / at risk     0/327 (0.00%)     1/328 (0.30%)     0/328 (0.00%)     2/332 (0.60%)  
Pneumonia † 1        
# participants affected / at risk     0/327 (0.00%)     0/328 (0.00%)     0/328 (0.00%)     1/332 (0.30%)  
Respiratory Tract Infection † 1        
# participants affected / at risk     0/327 (0.00%)     0/328 (0.00%)     0/328 (0.00%)     1/332 (0.30%)  
Rhinitis † 1        
# participants affected / at risk     0/327 (0.00%)     2/328 (0.61%)     0/328 (0.00%)     1/332 (0.30%)  
Sinusitis † 1        
# participants affected / at risk     2/327 (0.61%)     2/328 (0.61%)     2/328 (0.61%)     2/332 (0.60%)  
Staphylococcal Infection † 1        
# participants affected / at risk     1/327 (0.31%)     0/328 (0.00%)     0/328 (0.00%)     0/332 (0.00%)  
Tinea Infection † 1        
# participants affected / at risk     0/327 (0.00%)     0/328 (0.00%)     0/328 (0.00%)     1/332 (0.30%)  
Tonsillitis † 1        
# participants affected / at risk     0/327 (0.00%)     0/328 (0.00%)     0/328 (0.00%)     1/332 (0.30%)  
Tooth Abscess † 1        
# participants affected / at risk     1/327 (0.31%)     0/328 (0.00%)     0/328 (0.00%)     1/332 (0.30%)  
Tooth Infection † 1        
# participants affected / at risk     1/327 (0.31%)     0/328 (0.00%)     1/328 (0.30%)     0/332 (0.00%)  
Upper Respiratory Tract Infection † 1        
# participants affected / at risk     11/327 (3.36%)     13/328 (3.96%)     13/328 (3.96%)     13/332 (3.92%)  
Urinary Tract Infection † 1        
# participants affected / at risk     1/327 (0.31%)     2/328 (0.61%)     1/328 (0.30%)     2/332 (0.60%)  
Vaginal Infection † 1        
# participants affected / at risk     0/327 (0.00%)     1/328 (0.30%)     0/328 (0.00%)     1/332 (0.30%)  
Varicella † 1        
# participants affected / at risk     0/327 (0.00%)     0/328 (0.00%)     0/328 (0.00%)     1/332 (0.30%)  
Viral Infection † 1        
# participants affected / at risk     1/327 (0.31%)     0/328 (0.00%)     0/328 (0.00%)     1/332 (0.30%)  
Viral Upper Respiratory Tract Infection † 1        
# participants affected / at risk     0/327 (0.00%)     0/328 (0.00%)     0/328 (0.00%)     1/332 (0.30%)  
Vulvovaginal Mycotic Infection † 1        
# participants affected / at risk     0/327 (0.00%)     1/328 (0.30%)     0/328 (0.00%)     0/332 (0.00%)  
Injury, poisoning and procedural complications          
Arthropod Bite † 1        
# participants affected / at risk     0/327 (0.00%)     0/328 (0.00%)     0/328 (0.00%)     0/332 (0.00%)  
Excoriation † 1        
# participants affected / at risk     1/327 (0.31%)     1/328 (0.30%)     2/328 (0.61%)     1/332 (0.30%)  
Fractured Coccyx † 1        
# participants affected / at risk     0/327 (0.00%)     1/328 (0.30%)     0/328 (0.00%)     0/332 (0.00%)  
Head Injury † 1        
# participants affected / at risk     0/327 (0.00%)     1/328 (0.30%)     0/328 (0.00%)     0/332 (0.00%)  
Injury † 1        
# participants affected / at risk     0/327 (0.00%)     0/328 (0.00%)     0/328 (0.00%)     0/332 (0.00%)  
Joint Sprain † 1        
# participants affected / at risk     0/327 (0.00%)     2/328 (0.61%)     5/328 (1.52%)     0/332 (0.00%)  
Limb Crushing Injury † 1        
# participants affected / at risk     1/327 (0.31%)     0/328 (0.00%)     0/328 (0.00%)     0/332 (0.00%)  
Muscle Strain † 1        
# participants affected / at risk     0/327 (0.00%)     1/328 (0.30%)     0/328 (0.00%)     1/332 (0.30%)  
Neck Injury † 1        
# participants affected / at risk     0/327 (0.00%)     0/328 (0.00%)     1/328 (0.30%)     0/332 (0.00%)  
Post-Traumatic Pain † 1        
# participants affected / at risk     1/327 (0.31%)     0/328 (0.00%)     0/328 (0.00%)     0/332 (0.00%)  
Procedural Pain † 1        
# participants affected / at risk     2/327 (0.61%)     1/328 (0.30%)     0/328 (0.00%)     2/332 (0.60%)  
Radius Fracture † 1        
# participants affected / at risk     1/327 (0.31%)     0/328 (0.00%)     0/328 (0.00%)     0/332 (0.00%)  
Skin Laceration † 1        
# participants affected / at risk     0/327 (0.00%)     2/328 (0.61%)     1/328 (0.30%)     1/332 (0.30%)  
Sunburn † 1        
# participants affected / at risk     2/327 (0.61%)     5/328 (1.52%)     1/328 (0.30%)     2/332 (0.60%)  
Thermal Burn † 1        
# participants affected / at risk     1/327 (0.31%)     0/328 (0.00%)     0/328 (0.00%)     0/332 (0.00%)  
Upper Limb Fracture † 1        
# participants affected / at risk     0/327 (0.00%)     0/328 (0.00%)     2/328 (0.61%)     0/332 (0.00%)  
Wrist Fracture † 1        
# participants affected / at risk     0/327 (0.00%)     0/328 (0.00%)     1/328 (0.30%)     0/332 (0.00%)  
Investigations          
Blood Testosterone Increased † 1        
# participants affected / at risk     0/327 (0.00%)     0/328 (0.00%)     1/328 (0.30%)     0/332 (0.00%)  
Musculoskeletal and connective tissue disorders          
Arthralgia † 1        
# participants affected / at risk     1/327 (0.31%)     0/328 (0.00%)     0/328 (0.00%)     0/332 (0.00%)  
Back Pain † 1        
# participants affected / at risk     2/327 (0.61%)     1/328 (0.30%)     0/328 (0.00%)     0/332 (0.00%)  
Musculoskeletal Stiffness † 1        
# participants affected / at risk     0/327 (0.00%)     0/328 (0.00%)     1/328 (0.30%)     0/332 (0.00%)  
Neck Pain † 1        
# participants affected / at risk     1/327 (0.31%)     0/328 (0.00%)     0/328 (0.00%)     0/332 (0.00%)  
Neoplasms benign, malignant and unspecified (incl cysts and polyps)          
Melanocytic Naevus † 1        
# participants affected / at risk     0/327 (0.00%)     1/328 (0.30%)     0/328 (0.00%)     0/332 (0.00%)  
Skin Papilloma † 1        
# participants affected / at risk     1/327 (0.31%)     0/328 (0.00%)     1/328 (0.30%)     0/332 (0.00%)  
Nervous system disorders          
Convulsion † 1        
# participants affected / at risk     0/327 (0.00%)     0/328 (0.00%)     0/328 (0.00%)     1/332 (0.30%)  
Dizziness † 1        
# participants affected / at risk     0/327 (0.00%)     1/328 (0.30%)     0/328 (0.00%)     0/332 (0.00%)  
Headache † 1        
# participants affected / at risk     4/327 (1.22%)     8/328 (2.44%)     9/328 (2.74%)     7/332 (2.11%)  
Migraine † 1        
# participants affected / at risk     1/327 (0.31%)     0/328 (0.00%)     0/328 (0.00%)     0/332 (0.00%)  
Paraesthesia † 1        
# participants affected / at risk     0/327 (0.00%)     0/328 (0.00%)     1/328 (0.30%)     0/332 (0.00%)  
Sinus Headache † 1        
# participants affected / at risk     0/327 (0.00%)     1/328 (0.30%)     0/328 (0.00%)     0/332 (0.00%)  
Syncope † 1        
# participants affected / at risk     0/327 (0.00%)     0/328 (0.00%)     1/328 (0.30%)     0/332 (0.00%)  
Tremor † 1        
# participants affected / at risk     0/327 (0.00%)     0/328 (0.00%)     0/328 (0.00%)     1/332 (0.30%)  
Psychiatric disorders          
Anxiety † 1        
# participants affected / at risk     0/327 (0.00%)     0/328 (0.00%)     1/328 (0.30%)     0/332 (0.00%)  
Attention Deficit/Hyperactivity Disorder † 1        
# participants affected / at risk     0/327 (0.00%)     0/328 (0.00%)     0/328 (0.00%)     1/332 (0.30%)  
Depression † 1        
# participants affected / at risk     1/327 (0.31%)     0/328 (0.00%)     1/328 (0.30%)     0/332 (0.00%)  
Nephrolithiasis † 1        
# participants affected / at risk     0/327 (0.00%)     0/328 (0.00%)     1/328 (0.30%)     0/332 (0.00%)  
Renal and urinary disorders          
Nephrolithiasis † 1        
# participants affected / at risk     0/327 (0.00%)     1/328 (0.30%)     0/328 (0.00%)     0/332 (0.00%)  
Reproductive system and breast disorders          
Adnexa Uteri Pain † 1        
# participants affected / at risk     0/327 (0.00%)     0/328 (0.00%)     0/328 (0.00%)     1/332 (0.30%)  
Breast Cyst † 1        
# participants affected / at risk     0/327 (0.00%)     1/328 (0.30%)     0/328 (0.00%)     0/332 (0.00%)  
Dysmenorrhoea † 1        
# participants affected / at risk     1/327 (0.31%)     0/328 (0.00%)     1/328 (0.30%)     2/332 (0.60%)  
Endometriosis † 1        
# participants affected / at risk     0/327 (0.00%)     1/328 (0.30%)     0/328 (0.00%)     0/332 (0.00%)  
Ovarian Cyst Ruptured † 1        
# participants affected / at risk     0/327 (0.00%)     0/328 (0.00%)     1/328 (0.30%)     0/332 (0.00%)  
Respiratory, thoracic and mediastinal disorders          
Cough † 1        
# participants affected / at risk     2/327 (0.61%)     0/328 (0.00%)     1/328 (0.30%)     2/332 (0.60%)  
Epistaxis † 1        
# participants affected / at risk     0/327 (0.00%)     1/328 (0.30%)     0/328 (0.00%)     0/332 (0.00%)  
Nasal Congestion † 1        
# participants affected / at risk     1/327 (0.31%)     1/328 (0.30%)     2/328 (0.61%)     0/332 (0.00%)  
Pharyngolaryngeal Pain † 1        
# participants affected / at risk     3/327 (0.92%)     0/328 (0.00%)     2/328 (0.61%)     2/332 (0.60%)  
Respiratory Tract Congestion † 1        
# participants affected / at risk     0/327 (0.00%)     0/328 (0.00%)     1/328 (0.30%)     0/332 (0.00%)  
Rhinitis Allergic † 1        
# participants affected / at risk     0/327 (0.00%)     0/328 (0.00%)     0/328 (0.00%)     1/332 (0.30%)  
Rhinorrhea † 1        
# participants affected / at risk     0/327 (0.00%)     0/328 (0.00%)     0/328 (0.00%)     1/332 (0.30%)  
Sinus Congestion † 1        
# participants affected / at risk     1/327 (0.31%)     0/328 (0.00%)     1/328 (0.30%)     1/332 (0.30%)  
Skin and subcutaneous tissue disorders          
Acne † 1        
# participants affected / at risk     0/327 (0.00%)     1/328 (0.30%)     1/328 (0.30%)     1/332 (0.30%)  
Chloasma † 1        
# participants affected / at risk     0/327 (0.00%)     0/328 (0.00%)     1/328 (0.30%)     0/332 (0.00%)  
Dermatitis Atopic † 1        
# participants affected / at risk     0/327 (0.00%)     1/328 (0.30%)     0/328 (0.00%)     0/332 (0.00%)  
Dermatitis Contact † 1        
# participants affected / at risk     1/327 (0.31%)     1/328 (0.30%)     0/328 (0.00%)     1/332 (0.30%)  
Ingrowing Nail † 1        
# participants affected / at risk     0/327 (0.00%)     0/328 (0.00%)     0/328 (0.00%)     1/332 (0.30%)  
Pruritus † 1        
# participants affected / at risk     0/327 (0.00%)     0/328 (0.00%)     1/328 (0.30%)     1/332 (0.30%)  
Rash † 1        
# participants affected / at risk     0/327 (0.00%)     1/328 (0.30%)     0/328 (0.00%)     0/332 (0.00%)  
Urticaria † 1        
# participants affected / at risk     0/327 (0.00%)     0/328 (0.00%)     2/328 (0.61%)     0/332 (0.00%)  
Surgical and medical procedures          
Elective Surgery † 1        
# participants affected / at risk     0/327 (0.00%)     0/328 (0.00%)     1/328 (0.30%)     0/332 (0.00%)  
Mole Excision † 1        
# participants affected / at risk     1/327 (0.31%)     0/328 (0.00%)     0/328 (0.00%)     0/332 (0.00%)  
Tooth Extraction † 1        
# participants affected / at risk     0/327 (0.00%)     0/328 (0.00%)     0/328 (0.00%)     1/332 (0.30%)  
Wisdom Teeth Removal † 1        
# participants affected / at risk     1/327 (0.31%)     0/328 (0.00%)     2/328 (0.61%)     2/332 (0.60%)  
Vascular disorders          
Hypertension † 1        
# participants affected / at risk     0/327 (0.00%)     0/328 (0.00%)     1/328 (0.30%)     0/332 (0.00%)  
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA



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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 agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:  
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


No publications provided


Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00776919     History of Changes
Other Study ID Numbers: 114677, W0261-301
Study First Received: October 21, 2008
Results First Received: December 21, 2011
Last Updated: February 9, 2012
Health Authority: Canada: Health Canada
United States: Food and Drug Administration