Clinical study on the analgesic efficacy of a 4-week combination of NSAIDs patch and celecoxib in patients with Knee Osteoarthritis who responded poorly to monotherapy with NSAIDs patch (A randomized, open-label, parallel-group, controlled study compared to home based exercise therapy)
- Conditions
- Knee Osteoarthritis
- Registration Number
- JPRN-UMIN000007719
- Lead Sponsor
- Sapporo Medical University School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 72
Not provided
(1)Patients diagnosed with rheumatoid arthritis, inflammatory arthritis, or gout, or those with injuries at evaluated region. (2)Patients who have received surgical or drug treatment for the evaluated knee during the study period. (3)Patients with diseases requiring continuous or intermittent steroid administration. (4)Patients requiring use of topical drugs (e.g., ointment, suppository) during the study period. (5)Patients with history of hypersensitivity to the ingredient of celecoxib, sulfonamide, or ketoprofen. (6)Patients with (history of) aspirin asthma (asthma attacks induced by NSAIDs, analgesics, etc.). (7)Patients with history of hypersensitivity to products containing tiaprofenic acid, suprofen, fenofibrate, oxybenzone, and octocrylene. (8)Patients with history of photosensitivity. (9)Patients with peptic ulcers. (10)Patients with severe hepatic disorders. (11)Patients with severe renal disorders. (12)Patients with severe cardiac dysfunctions. (13)Perioperative patients undergoing coronary artery bypass reconstruction. (14)Women at the end of pregnancy. (15)Other patients considered unsuited for the study by their doctors.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Average change in pain VAS at the final assessment from the baseline.
- Secondary Outcome Measures
Name Time Method (1)General improvement rate evaluated by doctor at final assessment (assessed in five stages: 1. Marked improvement, 2. Moderate improvement, 3. Slight improvement, 4. Unchanged, 5. Worse). (2)Comparison of improvement rates (changes from baseline) of Japanese Knee Osteoarthritis Measure score at final assessment. (3)Average change in pain VAS according to patient diary (Comparison between baseline and day 1, day 3, day 7, day 14, and day 28 of celecoxib treatment or exercise treatment). (4)Health and sleep patterns according to patient diary (Comparison between baseline and day 1, day 3, day 7, day 14, and day 28 of celecoxib treatment or exercise treatment). (5)Compliance with exercise treatment according to patient questionnaire on treatment at final assessment. (6)Treatment compliance according to patient questionnaire on treatment at final assessment.