N/A
N=293
Effect Of Meloxicam Versus Placebo In Mainland Chinese Patients With Osteoarthritis Of The Knee
Osteoarthritis of the Knee
Bottom Line
View on ClinicalTrials.gov: NCT01430559 ↗Enrolled (actual)
293
Serious AEs
0.5%
Results posted
Dec 2020
Primary outcome: Primary: The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total and the 3 Subscales Scores (Pain, Stiffness and Physical Function) at Screening 1 by Using a Paper Worksheet and a Personalized Electronic LogPad System (E-diary) — 5.7; 5.3; 5.7; 135.9 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Meloxicam (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Mar 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total and the 3 Subscales Scores (Pain, Stiffness and Physical Function) at Screening 1 by Using a Paper Worksheet and a Personalized Electronic LogPad System (E-diary) |
5.7; 5.3; 5.7; 135.9; 5.7; 0.1 | — |
| PRIMARY WOMAC Total and the 3 Subscales Scores (Pain, Stiffness and Physical Function) at Screening 2 by Using E-diary |
5.6; 5.4; 5.8; 136.6 | — |
| PRIMARY WOMAC Total and the 3 Subscales Scores (Pain, Stiffness and Physical Function) at Baseline by Using E-diary |
6.0; 6.0; 5.7; 5.6; 6.1; 6.1 | — |
| PRIMARY WOMAC Total and the 3 Subscales Scores (Pain, Stiffness and Physical Function) at Week 12 by Using E-diary |
4.4; 3.6; 4.2; 3.5; 4.5; 3.7 | — |
| PRIMARY Change From Baseline in WOMAC Pain Subscale Scores at Week 12 |
-1.24; -2.06 | <0.0001 sig |
| SECONDARY Change From Baseline in WOMAC Subscale and Average Scores at Weeks 2, 4, 8 and 12 |
-0.76; -1.12; -1.18; -1.53; -1.31; -1.82 | 0.0103 sig |
| SECONDARY Change From Baseline in WOMAC Pain Subscale Items at Weeks 2, 4, 8 and 12 |
-0.51; -1.13; -1.04; -1.61; -1.17; -1.87 | 0.0002 sig |
| SECONDARY Percentage of Participants With Cumulative Reduction From Baseline in WOMAC Pain Subscale at Week 12 |
53.1; 75.7; 46.2; 67.4; 37.1; 58.3 | — |
| SECONDARY Percentage of Participants With at Least 30% and 50% Reduction From Baseline in the WOMAC Pain Subscale at Weeks 2, 4, 8, and 12 |
17.48; 22.92; 30.07; 36.81; 34.97; 45.14 | 0.2373 |
| SECONDARY Change From Baseline in Patient Global Assessment of Osteoarthritis (PGAO) at Weeks 2, 4, 8 and 12 |
-0.27; -0.45; -0.37; -0.53; -0.34; -0.52 | 0.0027 sig |
| SECONDARY Percentage of Participants With >=2 Points Improvement in PGAO From Baseline at Weeks 2, 4, 8, and 12 |
2.80; 4.86; 6.29; 11.81; 5.59; 6.25 | 0.2843 |
| SECONDARY Change From Baseline in Short-Form 36 Health Survey (SF-36) Domain Scores and Component Scores at Week 12 |
4.60; 5.98; 6.95; 12.88; 5.79; 13.95 | 0.3738 |
| SECONDARY Percentage of Participants With Change From Baseline in EuroQoL-5 Domains (EQ-5D) Level at Week 12 |
0; 0; 2.8; 0.7; 79.7; 66.0 | 0.0014 sig |
| SECONDARY Change From Baseline in Weekly Average Pain Score in the Index Knee Using 11-point Numeric Rating Scale (NRS) at Weeks 2, 4, 8 and 12 |
-0.67; -0.97; -1.11; -1.42; -1.31; -1.76 | 0.0367 sig |
Summary
This study is to validate the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) tool in mainland Chinese patients with osteoarthritis of the knee . This study will also evaluate the effects of Mobic versus placebo on reducing the symptoms of osteoarthritis in this population.
Eligibility Criteria
Inclusion Criteria
Subjects are required to meet the following criteria to be eligible for Randomization into this study:
- Male or female Chinese subjects, 18-75 years of age;
- Subjects must have a diagnosis of OA of the index knee based on American College of Rheumatology criteria with X ray confirmation (a Kellgren Lawrence x ray grade of greater than or equal to 2) (Kellgren J. & Lawrence J, 1957)
- Subjects must have have an NRS and a WOMAC pain sub scale score of 4 at Screening and at Baseline based on four daily diary entries
Exclusion Criteria
Subjects presenting with any of the following will not be included in the study:
- History of other disease that may involve the index (painful) knee including inflammatory joint diseases or have had recent surgical intervention on the knee.
- Diagnosed as having or has been treated for esophageal, gastric, pyloric channel, or duodenal ulceration within 30 days prior to receiving the first dose of study medication. History of or active gastrointestinal disease (eg, inflammatory bowel disease), a chronic or acute renal or hepatic disorder, or a significant coagulation defect.
- Signs and symptoms of clinically significant cardiac disease
Data sourced from ClinicalTrials.gov (NCT01430559). 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.