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

NCT ID: NCT01801735

Last Updated: 2015-05-12

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2014-08-31

Brief Summary

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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

Detailed Description

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Conditions

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Osteoarthritis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Meloxicam Test Capsules

One Capsule QD

Group Type EXPERIMENTAL

Meloxicam Test Capsules

Intervention Type DRUG

Interventions

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Meloxicam Test Capsules

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Iroko Pharmaceuticals, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Birmingham, Alabama, United States

Site Status

Phoenix, Arizona, United States

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Carmichael, California, United States

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Pismo Beach, California, United States

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Milford, Connecticut, United States

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DeLand, Florida, United States

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Fleming Island, Florida, United States

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Jacksonville, Florida, United States

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Jacksonville, Florida, United States

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Miami, Florida, United States

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Ormond Beach, Florida, United States

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Ponte Vedra, Florida, United States

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Newton, Kansas, United States

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Prairie Village, Kansas, United States

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Wichita, Kansas, United States

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Crestview Hills, Kentucky, United States

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Brockton, Massachusetts, United States

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Traverse City, Michigan, United States

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Troy, Michigan, United States

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Hazelwood, Missouri, United States

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St Louis, Missouri, United States

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Omaha, Nebraska, United States

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Las Vegas, Nevada, United States

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Hartsdale, New York, United States

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Greensboro, North Carolina, United States

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Cincinnati, Ohio, United States

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Cincinnati, Ohio, United States

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Cincinnati, Ohio, United States

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Cincinnati, Ohio, United States

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Columbus, Ohio, United States

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Kettering, Ohio, United States

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Duncansville, Pennsylvania, United States

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Anderson, South Carolina, United States

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Clinton, South Carolina, United States

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Austin, Texas, United States

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Plano, Texas, United States

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San Antonio, Texas, United States

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San Antonio, Texas, United States

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Charlottesville, Virginia, United States

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Roanoke, Virginia, United States

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Countries

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United States

Other Identifiers

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MEL3-12-03

Identifier Type: -

Identifier Source: org_study_id

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