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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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JPRN |
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Last refreshed on:
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17 October 2023 |
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Main ID: |
JPRN-UMIN000007719 |
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Date of registration:
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11/04/2012 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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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)
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Scientific title:
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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) - Clinical study on the analgesic efficacy of NSAIDs patch and celecoxib in patients with Knee Osteoarthritis who responded poorly to monotherapy with NSAIDs patch |
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Date of first enrolment:
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2012/02/01 |
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Target sample size:
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72 |
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Recruitment status: |
Complete: follow-up complete |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008612 |
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Study type:
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Interventional |
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Study design:
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Parallel Randomized
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Phase:
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Phase IV
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Countries of recruitment
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Japan
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Contacts
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Name:
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Kota Watanabe |
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Address:
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291 S1W17, Chuo-ku, Sapporo, 060-8556, Japan
Japan |
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Telephone:
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011-611-2111 |
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Email:
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Affiliation:
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Sapporo Medical University School of Medicine Department of Orthopaedic Surgery |
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Name:
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Kota Watanabe |
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Address:
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Japan |
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Telephone:
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011-611-2111 |
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Email:
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Affiliation:
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Sapporo Medical University School of Medicine Department of Orthopaedic Surgery |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: (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.
Age minimum:
30years-old
Age maximum:
90years-old
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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Knee Osteoarthritis
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Intervention(s)
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A fixed daily dose of Celecoxib (200mg/day in 2 divided doses) will be administered orally for 4 weeks.
home based exercise therapy for 4 weeks.
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Primary Outcome(s)
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Average change in pain VAS at the final assessment from the baseline.
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Secondary Outcome(s)
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(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.
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Source(s) of Monetary Support
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None
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Ethics review
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Status: YES
Approval date: 20/10/2011
Contact:
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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01/02/2013 |
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URL:
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