Overview

This trial is active, not recruiting.

Condition osteoarthritis
Treatment meloxicam test capsules
Phase phase 3
Sponsor Iroko Pharmaceuticals, LLC
Start date March 2013
End date July 2014
Trial size 600 participants
Trial identifier NCT01801735, MEL3-12-03

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
One Capsule QD
meloxicam test capsules

Primary Outcomes

Measure
Incidence rates of AEs
time frame: Baseline and Week 52

Eligibility Criteria

Male or female participants at least 40 years old.

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 (ecept Meloxicam SoluMatrix Capsules), device, or therapy within 30 days before Screening

Additional Information

Official title A Multicenter, Open-Label, Safety Study of Meloxicam SoluMatrix™ Capsules in Subjects With Osteoarthritis of the Knee or Hip
Trial information was received from ClinicalTrials.gov and was last updated in June 2013.
Information provided to ClinicalTrials.gov by Iroko Pharmaceuticals, LLC.