Phase 4
Completed N=1,772
Study Of "Continuous Use" Of Celecoxib Vs. "Usual or Intermittent Use"
Osteoarthritis, Knee · Osteoarthritis, Hip
Source: ClinicalTrials.gov NCT00139776 ↗
Enrolled (actual)
1,772
Serious AEs
—
Results posted
May 2009
Primary outcomePrimary: Number of Flare Events Per Time of Exposure to Study Medication — 0.54; 0.93 flare events per month — p=<0.0001
Summary
To determine whether "continuous use" of celecoxib over a 6-month period is more efficacious than "usual or intermittent use" in preventing spontaneous osteoarthritis flares of the knee and hip.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Flare Events Per Time of Exposure to Study Medication |
0.54; 0.93 | <0.0001 sig |
| SECONDARY Time to Occurrence of First Osteoarthritis (OA) Flare |
16.0; 8.0 | <0.0001 sig |
| SECONDARY Proportion of Days Free From Osteoarthritis (OA) Flare |
0.77; 0.67 | <0.0001 sig |
| SECONDARY Proportion of Days in Osteoarthritis (OA) Flare |
0.23; 0.33 | <0.0001 sig |
| SECONDARY Arthritis Pain Numerical Rating Scale (NRS) |
81.7; 90.5; 148.8; 167.0; 212.6; 234.3 | <0.001 sig |
| SECONDARY Patient's Global Assessment of Arthritis |
67.9; 71.7; 126.0; 133.2; 182.8; 188.7 | <0.001 sig |
| SECONDARY Physician's Global Assessment of Arthritis at Final Visit |
68; 39; 242; 244; 91; 113 | 0.0046 sig |
| SECONDARY Total Rescue Medication Taken (Mean) |
1566; 2428 | 0.0102 sig |
| SECONDARY Proportion of Days on Rescue Medication |
0.044; 0.069 | 0.0012 sig |
| SECONDARY Days on Flare Medication |
6.589; 9.793 | <0.0001 sig |
| SECONDARY Change in Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Scores |
1.60; 4.99; 0.37; 1.18; 0.12; 0.40 | <0.001 sig |
| SECONDARY Area Under the Curve (AUCs) of Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Scores |
604.9; 693.6; 119.2; 138.4; 54.5; 62.1 | <0.001 sig |
Eligibility Criteria
Inclusion Criteria
- Subject has been diagnosed, according to American College of Rheumatology guidelines, with osteoarthritis of the hip or knee and requires non-steroidal anti-inflammatory drugs (NSAIDs) to control their osteoarthritis pain and have access to a touch-tone telephone.
Exclusion Criteria
- Subject has had surgery on index joint.
- Subject has history of rheumatoid arthritis or fibromyalgia syndrome.
- Subject has active gastrointestinal or cardiovascular disease.
Data sourced from ClinicalTrials.gov (NCT00139776). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.