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 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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000007719

Enrollment

Registered

2012-04-11

Start date

2012-02-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Osteoarthritis

Interventions

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.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Patients diagnosed with osteoarthritis of the knee by the doctor (irrelevant of gender) (2) Age range from 30 to 90 years. (3) Patients responding poorly to NSAID patch alone for more than 2 weeks (visit 2) (VAS value &#8805; 30 mm). (4) Patients graded between 1 to 4 according to the Kellgren and Lawrence Classification. (5) Patients willing to sign written consent regarding participation in this study.

Exclusion 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.

Design outcomes

Primary

Measure	Time frame
Average change in pain VAS at the final assessment from the baseline.	—

Secondary

Measure	Time frame
(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.	—

Measure

Time frame

(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.

—

Countries

Japan

Contacts

Public ContactKota Watanabe

Sapporo Medical University School of Medicine Department of Orthopaedic Surgery

011-611-2111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026