Study of Meloxicam Capsules to Treat Osteoarthritis Pain

Iroko Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Osteoarthritis

Treatments: Drug: Meloxicam Test Capsules; Drug: Placebo Capsules

Study type: Interventional

Funder types: Industry

Identifiers

NCT01787188

MEL3-12-02

Details and patient eligibility

About

The purpose of this study is to determine whether Meloxicam [Test] Capsules are safe and effective for the treatment of osteoarthritis pain of the knee or hip.

Enrollment: 403 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Primary diagnosis of Functional Class I-III OA of the hip or knee
• Chronic user of nonsteroidal anti-inflammatory drugs (NDAIDs) and/or acetaminophen for OA pain
• Discontinued all analgesic therapy at Screening
• For women of child-bearing potential: a woman who is not pregnant and not nursing, and who is practicing an acceptable method of birth control

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
• Previous participation in another clinical study of Meloxicam Capsules or received any investigational drug or device or investigational therapy within 30 days before Screening

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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403 participants in 3 patient groups, including a placebo group

Meloxicam Test Capsules low dose QD

Experimental group

Description:

Meloxicam Test Capsules low dose QD

Treatment:

Drug: Meloxicam Test Capsules

Drug: Meloxicam Test Capsules

Meloxicam Test Capsules high dose QD

Experimental group

Description:

Meloxicam Test Capsules high dose QD

Treatment:

Drug: Meloxicam Test Capsules

Drug: Meloxicam Test Capsules

Placebo Capsule QD

Placebo Comparator group

Description:

Placebo Capsule QD

Treatment:

Drug: Placebo Capsules