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

History of Changes

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
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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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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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 ]

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2. Primary:

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

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3. Primary:

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

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4. Primary:

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

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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 ]

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6. Secondary:

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

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7. Secondary:

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

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8. Secondary:

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

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9. Secondary:

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

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10. Secondary:

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

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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 ]

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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 ]

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13. Secondary:

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

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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 ]

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Serious Adverse Events

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Other Adverse Events

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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.

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

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