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GW842166

Phase 2

Osteoarthritis | Small molecule | Musculoskeletal |GSK plc|Last Updated: Jul 11, 2017

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment1
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00479427A Study Of The Effects Of CB2 Compound Of GW842166 In Patients With OsteoarthritisPHASE2 COMPLETED 1Jul 6, 2007Oct 9, 2007Jul 11, 20171 United Kingdom
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Study Endpoints
Primary Endpoints
Change in pain scores from Baseline to the end of treatment Western Ontario and McMasters University Osteoarthritis Index (WOMAC) using on the pain subscore for 6-8 weeks
Baseline (Day 1 pre-dose) and up to Day 14 of each treatment period (approximately up to 8 weeks)

The index consisted of 24 questions (5 for pain, 2 for stiffness and 17 for physical and composite functions). The visual analog scale (VAS; 0-100 millimeter \[mm\]) was utilized in this study and participants were asked to rate joint pain they had in last 24 hours in the 5 pain items. Participants were asked to rate pain while performing following activities: walking on a flat surface, going up or down stairs; at night while in bed; sitting or lying and standing upright. Higher score (100) indicates extreme pain and lower score (0) indicates no pain. It was assessed on Day 1 pre-dose (Baseline), Day 1 (1 hour post-dose) and Day 14 (2-4 hours post-dose). Change from Baseline was planned to be calculated by subtracting Baseline value from post-Baseline value. Due to the early termination of this study, no formal statistical analysis was performed. Only summarized data is available.

Secondary Endpoints
Quantitative Sensory Testing (QST) rating heat pain threshold and tolerance for 6-8 weeks
Up to Day 14 of each treatment period (approximately up to 8 weeks)
Change from Baseline to the end of treatment in WOMAC stiffness subscore
Up to Day 14 of each treatment period (approximately up to 8 weeks)
Change from baseline to the end of treatment in WOMAC physical function subscore
Baseline (Day 1 pre-dose) and up to Day 14 of each treatment period (approximately up to 8 weeks)
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Study Design & Arms
AllocationRANDOMIZED
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Overall studyEXPERIMENTALoverall study population
Interventions
NameTypeDescription
GW842166DRUG100 mg once daily
PlaceboDRUGonce daily
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Eligibility Criteria
Age Range50 Years — 80 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Male or female patients, 50 to 80 years of age. * A female is eligible to participate in this study if she is of: a) non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is post-menopausal (more than 1 year since last menst...

Countries:United Kingdom
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