Phase 3
Completed N=600
Study of Meloxicam Capsules in Subjects With Osteoarthritis of the Knee or Hip
Source: ClinicalTrials.gov NCT01801735 ↗Enrolled (actual)
600
Serious AEs
5.8%
Results posted
May 2015
Primary outcomePrimary: Safety of Meloxicam 10 mg as Assessed by the Incidence of Adverse Events From Baseline to Week 52 or Early Termination — 406; 23; 35; 127 participants
Summary
The purpose of this study is to evaluate the safety of Meloxicam SoluMatrix Capsules for up to 52 weeks in subjects with pain due to osteoarthritis (OA) of the knee or hip
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety of Meloxicam 10 mg as Assessed by the Incidence of Adverse Events From Baseline to Week 52 or Early Termination |
406; 23; 35; 127; 79; 2 | — |
Eligibility Criteria
Inclusion Criteria
- Is male or female ≥ 40 years of age
- If a participant in the previous MEL3-12-02 study, completed the study and did not discontinue for lack of efficacy or safety
- Has a diagnosis of OA of the hip or knee with ongoing knee and/or articular hip pain
- Chronic user of nonsteroidal anti-inflammatory drugs (NSAIDs) and/or acetaminophen for OA pain
- If female and of childbearing potential, is nonlactating and nonpregnant
Exclusion Criteria
- History of allergic reaction or clinically significant intolerance to acetaminophen, aspirin, or any NSAIDs, including meloxicam
- Requires continuous use of opioid or opioid combination products to control OA pain of the knee or hip
- Clinically significant unstable cardiac, respiratory, neurological, immunological, hematological, or renal disease
- Significant difficulties swallowing capsules or unable to tolerate oral medication
- Has received any investigational drug (except Meloxicam SoluMatrix Capsules), device, or therapy within 30 days before Screening
Data sourced from ClinicalTrials.gov (NCT01801735). 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.