Meloxicam SoluMatrix® Capsules vs Meloxicam Tablets to Treat Osteoarthritis Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2015-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Meloxicam low dose test capsule

Meloxicam SoluMatrix Capsules - low dose QD

Group Type EXPERIMENTAL

Meloxicam Test Capsules

Intervention Type DRUG

Meloxicam high dose test capsule

Meloxicam SoluMatrix Capsules - high dose QD

Group Type EXPERIMENTAL

Meloxicam Test Capsules

Intervention Type DRUG

Meloxicam tablets

Meloxicam Tablets QD

Group Type ACTIVE_COMPARATOR

Meloxicam Tablets

Intervention Type DRUG

Interventions

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Meloxicam Test Capsules

Intervention Type DRUG

Meloxicam Test Capsules

Intervention Type DRUG

Meloxicam Tablets

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No