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NCT01799213 · ClinicalTrials.gov registry record · Phase 2

Discontinuing NSAIDs in Veterans With Knee Osteoarthritis

A Phase 2 study, sponsored by VA Office of Research and Development.

Completed
Registry status
Phase 2
Development phase
490
Enrollment target

NCT01799213: Completed Phase 2 study, sponsored by VA Office of Research and Development.

NCT01799213 is a Phase 2 study that has completed, run by VA Office of Research and Development. The registered enrollment target is 490 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01799213, a Phase 2 study, has completed, sponsored by VA Office of Research and Development.

COMPLETED
Registry status
Phase 2
Development phase
490 participants
Enrollment target

Study 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).

Interventions

  • BEHAVIORAL Cognitive Behavioral Therapy
  • DRUG Meloxicam 15 mg po QD

Trial Details

FieldValue
Enrollment Target 490 participants
Start Date 2013-09-02
Est. Completion 2018-10-05
Phase Phase 2

Sponsor

VA Office of Research and Development

1,668 total trials

What the Registry Record Tells You About NCT01799213

The ClinicalTrials.gov registry entry for NCT01799213 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 490 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is VA Office of Research and Development, which has 1,668 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Cognitive Behavioral Therapy is the first listed.

NCT01799213 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01799213 about?

NCT01799213 is a clinical study titled "Discontinuing NSAIDs in Veterans With Knee Osteoarthritis". 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 t...

What is the current status of trial NCT01799213?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 490 participants. The study started on 2013-09-02. Estimated completion is 2018-10-05.

What interventions are being tested in trial NCT01799213?

The interventions under investigation include: Cognitive Behavioral Therapy (BEHAVIORAL), Meloxicam 15 mg po QD (DRUG).

Who is sponsoring clinical trial NCT01799213?

This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.