Study of Meloxicam Capsules in Subjects With Osteoarthritis of the Knee or Hip
Overview
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
Full Title of Study: “A Multicenter, Open-Label, Safety Study of Meloxicam SoluMatrix™ Capsules in Subjects With Osteoarthritis of the Knee or Hip”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: N/A
- Intervention Model: Single Group Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: June 2014
Interventions
- Drug: Meloxicam Test Capsules
Arms, Groups and Cohorts
- Experimental: Meloxicam Test Capsules
- One Capsule QD
Clinical Trial Outcome Measures
Primary Measures
- Safety of Meloxicam 10 mg as Assessed by the Incidence of Adverse Events From Baseline to Week 52 or Early Termination
- Time Frame: Baseline to Week 52/Early Termination
- The safety of Meloxicam 10 mg was assessed by the number of subjects with treatment-emergent adverse events (TEAEs), severe TEAEs, serious adverse events, treatment-related TEAEs, and adverse events (AEs) leading to discontinuation and subjects who died.
Participating in This Clinical Trial
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
Gender Eligibility: All
Minimum Age: 40 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Iroko Pharmaceuticals, LLC
- Provider of Information About this Clinical Study
- Sponsor
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