Phase III, 12-week, multicenter, double-blind, double-simulation study, with random assignment to treatment groups, controlled with placebo and with active comparator, from parallel groups, to investigate the efficacy and safety of GW 406381 administered in doses of 1,5,10,25 and 50 mg orally once a day to adult patients with osteoarthritis of the knee

GLAXOSMITHKLINE PERU S.A.,0 sites0 target enrollmentStarted: June 8, 2005Last updated: September 4, 2023

Conditions

Trial Snapshot

No summary available.

•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 <80.
•9. With score of question 1, pain subscale, of the WOMAC questionnaire in the initial assessment> 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.

•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).

Sponsor

GLAXOSMITHKLINE PERU S.A.,