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

Iroko Pharmaceuticals

Status and phase

Completed

Phase 3

Conditions

Osteoarthritis

Treatments

Drug: Meloxicam Test Capsules

Study type

Interventional

Funder types

Industry

Identifiers

NCT01801735

MEL3-12-03

Details and patient eligibility

About

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

Enrollment

600 patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

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