Last updated: 11/04/2018 06:06:53
Evaluation of GW406381 in treating Adults with Osteoarthritis Of The Knee
GSK study ID
CXA30007
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A Phase III, 12-week, Multicentre, Double-blind, Double-dummy, Randomised, Placebo and Active Comparator-Controlled, Parallel Group study to investigate the Efficacy and Safety of GW406381 1mg, 5mg, 10mg, 25mg and 50mg administered orally once daily, in adults with Osteoarthritis of the knee.
Trial description: This study was designed to evaluate the effectiveness of GW406381 (a COX-2 inhibitor) in treating the signs and symptoms of osteoarthritis of the knee.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Change from Baseline to week 12 in Western Ontario and McMasters Universities osteoarthritis (OA) Index (WOMAC) pain subscale score
Timeframe: Baseline (Day 1) and Week 12
Change from Baseline to week 12 in WOMAC physical function subscale score
Timeframe: Baseline (Day 1) and Week 12
Change from Baseline to week 12 in the patient global assessment of arthritis condition
Timeframe: Baseline (Day 1) and Week 12
Secondary outcomes:
Change from Baseline in WOMAC pain subscale score at each scheduled visit
Timeframe: Baseline (Day 1), Week 2, Week 4, Week 8 and Week 12
Change from Baseline in WOMAC pain subscale question 1 (pain walking on a flat surface) score at each scheduled visit
Timeframe: Baseline (Day 1), Week 2, 4, 8 and 12
Change from Baseline in WOMAC stiffness subscale score at each scheduled visit
Timeframe: Baseline (Day 1), Week 2, 4, 8 and 12
Change from Baseline in WOMAC physical function subscale score at each scheduled visit
Timeframe: Baseline (Day 1), Week 2, 4, 8 and 12
Change from Baseline in participant’s global assessment of arthritis condition at each scheduled visit
Timeframe: Baseline (Day 1), Week 2, 4, 8 and 12
Change from Baseline in physician’s global assessment of arthritis condition at each scheduled visit
Timeframe: Baseline (Day 1), Week 2, 4, 8 and 12
Percentage of responders as measured by the Osteoarthritis Research Society International (OARSI) responder index (using the OMERACT:OARSI definition) at each scheduled visit
Timeframe: Week 2, 4, 8 and 12
Number of participants discontinued due to lack of efficacy
Timeframe: Up to 12 Weeks
Percentage of participants who received supplementary analgesic therapy
Timeframe: Up to Week 12
Change in the Short Form-36 (SF-36v2) Health Status total and subscale scores between Baseline and the end of treatment (or early withdrawal)
Timeframe: Baseline (Day 1) and Week 12
Psychometrical test and validation of the amended Patient Satisfaction with Pain Medication Questionnaire (PMQ).
Timeframe: Up to Week 12
Change between Baseline and end of treatment (or early withdrawal) in the European Quality of Life -5 Dimensions Proxy version (EQ- 5D) scale total score-Thermometer score
Timeframe: Baseline (Day 1) and Week 12
Change between baseline and end of treatment (or early withdrawal) in the EQ - 5D utility score using the European population utility tariff
Timeframe: Baseline (Day 1) and Week 12
Interventions:
Enrollment:
1309
Primary completion date:
2007-15-09
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Osteoarthritis, Knee
Product
GW406381
Collaborators
Not applicable
Study date(s)
May 2005 to September 2007
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
40+ years
Accepts healthy volunteers
No
- Inclusion criteria:
- Subjects have a primary diagnosis of osteoarthritis of the knee with symptom duration of at least 3 months.
Inclusion and exclusion criteria
Inclusion criteria:
- Inclusion criteria:
- Subjects have a primary diagnosis of osteoarthritis of the knee with symptom duration of at least 3 months.
- Use pain medication, such as a COX-2 inhibitor or NSAID (non-steroidal anti-inflammatory drug) at least 5 days per week. Exclusion criteria:
- History of hypersensitivity or intolerance to pain medications.
- History of gastroduodenal perforations and/or obstructions.
- History of upper GI (gastrointestinal) ulceration within the previous 6 months.
- History of upper or lower GI bleeding within the previous year.
- History of inflammatory bowel disease.
- Currently take sucralfate or misoprostol.
- Currently taking aspirin daily for the heart.
- Other restrictions around the use medications apply and would need to be discussed.
- History of coronary artery disease, (angina, MI) or surgery.
- History of congestive heart failure or renal artery stenosis.
- History of stroke or transient ischemic attack.
- History of uncontrolled hypertension.
Trial location(s)
Location
GSK Investigational Site
Concinnati, Ohio, United States, 45219
Status
Study Complete
Location
GSK Investigational Site
Evansville, Indiana, United States, 47714
Status
Study Complete
Location
GSK Investigational Site
Drummondville, Québec, Canada, J2B 1H8
Status
Study Complete
Showing 1 - 6 of 231 Results
Study documents
No study documents available.
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Study complete
Actual primary completion date
2007-15-09
Actual study completion date
2007-15-09
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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