Meloxicam SoluMatrix® Capsules vs Meloxicam Tablets to Treat Osteoarthritis Pain

Iroko Pharmaceuticals

Status and phase: Withdrawn; Phase 2

Conditions: Osteoarthritis

Treatments: Drug: Meloxicam Test Capsules; Drug: Meloxicam Tablets

Study type: Interventional

Funder types: Industry

Identifiers

NCT02405793

MEL2-14-05

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and efficacy of a low dose and a high dose of Meloxicam SoluMatrix® Capsules versus Meloxicam Tablets for the treatment of pain due to osteoarthritis of the knee or hip.

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• History of allergic reaction or clinically significant intolerance to acetaminophen, aspirin, or any NSAIDs, including meloxicam
• Requires regular (more than 2 doses per week) 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/tablets 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: Single Blind

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0 participants in 3 patient groups

Meloxicam low dose test capsule

Experimental group

Description:

Meloxicam SoluMatrix Capsules - low dose QD

Treatment:

Drug: Meloxicam Test Capsules

Drug: Meloxicam Test Capsules

Meloxicam high dose test capsule

Experimental group

Description:

Meloxicam SoluMatrix Capsules - high dose QD

Treatment:

Drug: Meloxicam Test Capsules

Drug: Meloxicam Test Capsules

Meloxicam tablets

Active Comparator group

Description:

Meloxicam Tablets QD

Treatment:

Drug: Meloxicam Tablets