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GW842166

Phase 2

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

Success Probability

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Trial Design

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment1

FDA Designations

No designations recorded

Clinical trial landscape

GW842166 · 3 trials · 3 indications

Phase 2 3
NCT00479427A Study Of The Effects Of CB2 Compound Of GW842166 In Patients With OsteoarthritisOsteoarthritis
COMPLETED1 Analytics
NCT00447486A Study of GW842166 in Adults With Osteoarthritis PainOsteoarthritis, Knee
COMPLETED308 Analytics
NCT00444769Dental Pain 3rd Molar Tooth Extraction GW842166Pain
COMPLETED112 Analytics
PHASE2COMPLETED
A Study Of The Effects Of CB2 Compound Of GW842166 In Patients With Osteoarthritis
OsteoarthritisUnlock trial analytics
PHASE2COMPLETED
A Study of GW842166 in Adults With Osteoarthritis Pain
Osteoarthritis, KneeUnlock trial analytics
PHASE2COMPLETED
Dental Pain 3rd Molar Tooth Extraction GW842166
PainUnlock trial analytics

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.

The pain subscale score on the Western Ontario and McMasters Universities OA Index (WOMAC) taken at Day 28 compared to baseline
4 Weeks
Weighted mean of the pain intensity over the 10 hours post-surgery as measured by the VAS (Visual Analogue Scale)
over the 10 hours post-surgery

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 to 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 KingdomDenmarkGermanySpainSwedenItaly
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Frequently asked questions about GW842166

What is GW842166 used for?

GW842166 is an investigational small molecule being studied for the treatment of pain, including osteoarthritis and knee osteoarthritis. It has been evaluated in clinical trials for dental pain following third molar tooth extraction and for osteoarthritis pain in adults.

How does GW842166 work?

GW842166 is a small molecule that targets the CB2 receptor, a component of the endocannabinoid system involved in pain modulation. By acting on this receptor, it is intended to provide analgesic effects for pain conditions such as osteoarthritis.

Who is developing GW842166?

GW842166 is being developed by GSK plc, a global biopharmaceutical company listed on the stock exchange under the ticker symbol GSK. The company has sponsored clinical trials to evaluate the drug's safety and efficacy in pain-related indications.

What phase is GW842166 in?

GW842166 is in Phase 2 clinical development. All three completed trials were Phase 2 studies, including one in dental pain and two in osteoarthritis-related pain. The drug remains investigational and has not been approved by regulatory authorities.

What clinical trials is GW842166 in?

GW842166 has been studied in three completed Phase 2 trials: NCT00444769 for dental pain after third molar extraction, NCT00447486 for osteoarthritis knee pain, and NCT00479427 for osteoarthritis. These trials were conducted in European countries including Germany, Italy, the United Kingdom, Denmark, Spain, and Sweden.

Is GW842166 the same as a CB2 compound?

GW842166 is a CB2 receptor agonist, and one of its clinical trials, NCT00479427, is titled 'A Study Of The Effects Of CB2 Compound Of GW842166 In Patients With Osteoarthritis.' This indicates that GW842166 is a CB2-targeting compound, though it is not known by any other drug name.