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Discontinuing NSAIDs in Veterans With Knee Osteoarthritis

NCT01799213 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 490

Last updated 2023-07-27

Study results available
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Summary

Knee osteoarthritis (OA) is now recognized as a major health problem. It is the number one cause of lower extremity disability and has significant deleterious effects on quality of life. While there are numerous therapies available for knee OA, most have limited efficacy. Of particular concern, is the widespread use of nonsteroidal anti-inflammatory drugs (NSAIDs) for this disorder. Veterans, as a group, are at high risk for both gastrointestinal and cardiovascular NSAID-induced complications. In this study the investigators propose to examine whether replacing NSAIDs with cognitive behavioral therapy delivered by telephone is an effective strategy for Veterans with knee OA. Telephone-administered therapy is particularly appealing since Veterans with knee OA are more likely to have limited mobility. If successful, this program may result in significant cost-savings for both Veterans (decreased co-pays and transportation costs) and the VA (decreased hospitalizations due to NSAID induced toxicity).

Conditions

Interventions

DRUG

Meloxicam 15 mg po QD

Eligible subjects will be take Meloxicam 15 mg po QD

BEHAVIORAL

Cognitive Behavioral Therapy

Subjects originally assigned to placebo will receive cognitive behavioral therapy for 10 weeks

Sponsors & Collaborators

  • VA Office of Research and Development

    lead FED

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-02
Primary Completion
2018-10-05
Completion
2018-10-05
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01799213 on ClinicalTrials.gov