CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 490 enrolled
Drug / intervention
Meloxicam 15 mg po QD +1 moredrug
Likely dose
Meloxicam 15 mg po QDfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01799213
NCT01799213Phase 2Completed

Discontinuing NSAIDs in Veterans With Knee Osteoarthritis

VA Office of Research and Development·interventional·Posted Feb 26, 2013·Updated Jul 27, 2023

In Brief

A Phase 2 clinical trial evaluating Meloxicam 15 mg po QD and Cognitive Behavioral Therapy for Knee Osteoarthritis. Completed, enrolled 490 participants across 4 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedFeb 26, 2013
Enrollment StartSep 2, 2013
Primary CompletionOct 5, 2018
TodayJul 2, 2026
Enrollment to primary: 5.1 yearsPosted 13.3 years ago

Interventions

Meloxicam 15 mg po QDdrug

Eligible subjects will be take Meloxicam 15 mg po QD

Cognitive Behavioral Therapybehavioral

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