None listed
Conditions
Interventions
Group 1 Type of group
GW406381 PLACEBO will be administered once a day for a period of 12 weeks
Group name:Group 7 Type of group
GW406381 50 mg PO is administered once a day for a period of 12 weeks
Sponsors
GLAXOSMITHKLINE PERU S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: 1. Ambulatory patients of both sexes, of 40 or more years of age. 2. The patient is able and willing to give written informed consent. 3. The patient is able to read, understand and record the information required in the protocol. 4. Satisfies the clinical and radiographic criteria of the American College of Rheumatology for the classification of primary (idiopathic) osteoarthritis of the knee. 5. Diagnosis of primary osteoarthritis of the knee with duration of symptoms at least 3 months before the screening visit. 6. Documented evidence in an anteroposterior radiograph of tibiofemoral osteoarthritis within the previous 12 months. 7. Functional Class of the American Rheumatology Association I, II or III. 8. With score of question 1, subscale of pain, of the WOMAC questionnaire in the count 50. 10. Minimum worsening of 15 mm between the counting visit and the initial assessment in the score of question 1, pain subscale, of the WOMAC questionnaire. 11. It shows a minimal deterioration, between the screening visit and the initial assessment visit, of 1 point in the global assessment of arthritis by the patient. 12. Patients who have taken NSAIDs / COX-2 enzyme inhibitors for the treatment of their osteoarthritis of the knee for at least 5 of 7 days in each of the 4 weeks prior to the screening visit.
Exclusion criteria
Exclusion criteria: 1. Known history of hypersensitivity or intolerance to NSAIDs, aspirin, inhibitors of the COX-2 enzyme. 2. Any significant clinical or biological abnormality identified during the screening. 3. History of perforations and / or gastroduodenal obstructions. 4. History of any gastric or duodenal surgery. 5. Active gastrointestinal ulceration of the upper gastrointestinal tract within the previous 6 months, haemorrhage of the upper gastrointestinal tract within the previous year. 6. History of low digestive tract hemorrhage within the last year. 7. History of inflammatory bowel disease. 8. Use of proton pump inhibitors. 9. Use of sucralfate or misoprostol 10. Use of potent inhibitors of the CYP3A4 isoenzyme. 11. History of coronary artery disease, myocardial infarction or any surgery of the coronary arteries. 12. History of congestive heart failure or renal artery stenosis. 13. History of cerebral vascular accident or attack of transient cerebral ischemia. 14. Uncontrolled hypertension, treated or untreated. 15. Subjects who are taking aspirin. 16. Use of a combination of a diuretic with either an angiotensin-converting enzyme (ACE) inhibitor or an angiotensin receptor blocker (ARB).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:1) Pain level: Pain subscale of the Osteoarthritis Index of the Universities of Western Ontario and McMasters (WOMAC). 2) Level of Functionality: Subscale of physical function of the WOMAC 3) Subjective improvement: Overall assessment of osteoarthritis by the patient Measure:Level of pain. Level of physical functionality. Subjective improvement Timepoints:At the end of week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:1) Pain level: WOMAC pain subscale measured at each scheduled visit. 2) Pain when walking on a flat surface: Assessment at each scheduled visit of question 1 of the WOMAC pain subscale 3) Stiffness level: WOMAC stiffness subscale measured at each scheduled visit. 4) Level of functionality: Sub-scale of physical functionality of the WOMAC measured at each scheduled visit. 5) Subjective improvement: Overall assessment of osteoarthritis by the patient and by the doctor at each scheduled visit. 6) Percentage of patients with adequate clinical response: Adequate Response Index of the International Osteoarthritis Research Society (OARSI). Measure:Level of pain at each scheduled visit. Pain when walking on a flat surface at each scheduled visit. Level of rigidity at each scheduled visit. Level of functionality at each scheduled visit. Subjective improvement at each scheduled visit. Percentage of patients with adequate clinical response at each scheduled visit. Timepoints:Days 1, 14, 28, 56 y 84 | — |
Countries
Argentina, Australia, Belgium, Bulgaria, Canada, Denmark, Germany, Hungary, Korea South, Mexico, Netherlands, New Zealand, Norway, Poland, Romania, Spain, Sweden, United States
Outcome results
None listed