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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, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (268% higher). According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
The WOMAC pain score has a possible score range of 0-20 for Pain and higher scores indicate worse pain. The WOMAC pain scale consists of 5 questions that ask about pain during walking, stair use, lying in bed at night, sitting, and standing. Each question is scored on a 5-point scale, where 0 = None, 1 = Mild pain, 2 = Moderate pain, 3 = Severe pain, and 4 = Very severe pain. Total pain scores range from 0 to 20 with higher scores reflecting worse pain. The WOMAC also includes a lower extremity
Interventions
- BEHAVIORAL Cognitive Behavioral Therapy
- DRUG Meloxicam 15 mg po QD
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 490 participants |
| Start Date | 2013-09-02 |
| Est. Completion | 2018-10-05 |
| Phase | Phase 2 |
What the finished NCT01799213 record still lists
NCT01799213 is an interventional study that assigns participants to a tested intervention. The registered 490 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (268% higher).
The record links to 0 conditions, and to 2 interventions - of which Cognitive Behavioral Therapy is the first listed.
NCT01799213 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01799213's enrollment target sits among peer trials
490 76th of 2000 higher than 1,925 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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