Study of Meloxicam Capsules in Subjects With Osteoarthritis of the Knee or Hip

Phase 3

Completed

• Conditions: Osteoarthritis
• Interventions: Drug: Meloxicam Test Capsules

• Registration Number: NCT01801735
• Lead Sponsor: Iroko Pharmaceuticals, LLC

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-02-21
• Study First Submitted QC: 2013-02-27
• Study Start: 2013-03
• Study First Posted: 2013-03-01
• Primary Completion: 2014-06
• Study Completion: 2014-08
• Status Verified: 2015-04
• Results First Submitted: 2015-04-24
• Results First Submitted QC: 2015-04-24
• Last Update Submitted: 2015-04-24
• Results First Posted: 2015-05-12
• Last Update Posted: 2015-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Meloxicam Test Capsules	Meloxicam Test Capsules	One Capsule QD

Primary Outcome Measures

Name	Time	Method
Safety of Meloxicam 10 mg as Assessed by the Incidence of Adverse Events From Baseline to Week 52 or Early Termination	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.