Last updated: 07/13/2020 17:20:05
A Study of GW842166 in Adults with Osteoarthritis Pain
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A Multicentre, Randomised, Double-blind, Placebo and Naproxen (500mg) BID controlled, Phase II Proof of Concept, Parallel Group Study to Assess the Efficacy and Safety of Oral GW842166 at Two Dose Levels Administered for 4 weeks in Adults with Osteoarthritis of the Knee
Trial description: The purpose of this study is to determine whether GW842166 is effective in the treatment of osteoarthritis pain of the knee.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
The pain subscale score on the Western Ontario and McMasters Universities OA Index (WOMAC) taken at Day 28 compared to baseline
Timeframe: 4 Weeks
Secondary outcomes:
WOMAC pain subscale, stiffness, physical function scores and patient and physician global assessments
Timeframe: 4 Weeks
Interventions:
Drug: GW842166
Enrollment:
308
Observational study model:
Not applicable
Primary completion date:
2007-14-08
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Osteoarthritis, Knee
Product
GW842166
Collaborators
Not applicable
Study date(s)
April 2007 to August 2007
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
40+ years
Accepts healthy volunteers
No
- male or female outpatient, >= 40 years of age
- meets ACR clinical and radiographic criteria for classification of idiopathic (primary) osteoarthritis of the knee with symptom duration for at least 3 months
- any pre-specified clinical/biological/ECG abnormality
- any pre-specified drug sensitivity
Inclusion and exclusion criteria
Inclusion criteria:
- male or female outpatient, >= 40 years of age
- meets ACR clinical and radiographic criteria for classification of idiopathic (primary) osteoarthritis of the knee with symptom duration for at least 3 months
- meets ARA functional status requirements
- meets WOMAC pain subscale score requirements
- has taken analgesics for the treatment of their knee OA for at least 4 out of 7 days in each of the 4 weeks preceding screen
Exclusion criteria:
- any pre-specified clinical/biological/ECG abnormality
- any pre-specified drug sensitivity
- history of peptic ulceration or GI bleeding
- use of protocol-specified medications
- secondary cause of knee OA
- lower extremity surgery within 6 months of screening
- use of analgesics other than allowed per protocol
- use of corticosteroids or hyaluronan outside of allowed window prior to screening
Trial location(s)
Location
GSK Investigational Site
Essen, Nordrhein-Westfalen, Germany, 45359
Status
Study Complete
Location
GSK Investigational Site
Koeln, Nordrhein-Westfalen, Germany, 51069
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
2007-14-08
Actual study completion date
2007-14-08
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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