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NCT07649291 · ClinicalTrials.gov registry record · Phase 2
Duloxetine and aeRobic Exercise to Improve Function in VEterans With Knee Osteoarthritis (DRIVE)
A Phase 2 study, sponsored by VA Office of Research and Development.
- Not yet
- Registry status
- Phase 2
- Development phase
- 102
- Enrollment target
NCT07649291: Clinical Trial Phase 2 study, sponsored by VA Office of Research and Development.
NCT07649291 is a Phase 2 study that has not yet begun recruiting, run by VA Office of Research and Development. The registered enrollment target is 102 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (23% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07649291, a Phase 2 study, has not yet begun recruiting, sponsored by VA Office of Research and Development.
- NOT YET RECRUITING
- Registry status
- Phase 2
- Development phase
- 102 participants
- Enrollment target
Study Summary
Knee osteoarthritis (KOA) is one of the most common causes of chronic pain, mobility problems, and disability among United States Veterans. Many Veterans with KOA also experience depressive symptoms, which can worsen pain, reduce motivation to exercise, and make recovery more difficult. This study will test whether a structured hybrid aerobic exercise program that combines supervised and home-based walking with the medication duloxetine can improve physical function, reduce pain, lessen depressive symptoms, and improve overall health-related outcomes in Veterans with KOA. The goal of this research is to develop a practical and scalable treatment strategy that could improve rehabilitation and quality of life for Veterans with chronic knee pain and depressive symptoms and potentially be adapted for other chronic musculoskeletal conditions treated within the VA healthcare system.
Primary Outcome
20m WT (average time to walk 20 meters at usual pace across two trials) from baseline to 12 weeks, and between-group comparison (aerobic exercise + duloxetine vs. PT referral + duloxetine)
Interventions
- DRUG Placebo
- DRUG Duloxetine
- BEHAVIORAL Exercise
- BEHAVIORAL PT referral
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 102 participants |
| Start Date | 2027-03-01 |
| Est. Completion | 2032-09-01 |
| Phase | Phase 2 |
What is known before NCT07649291 opens enrollment
NCT07649291 is an interventional study that assigns participants to a tested intervention. The registered 102 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (23% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT07649291 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07649291 about?
NCT07649291 is a clinical study titled "Duloxetine and aeRobic Exercise to Improve Function in VEterans With Knee Osteoarthritis (DRIVE)". Knee osteoarthritis (KOA) is one of the most common causes of chronic pain, mobility problems, and disability among United States Veterans. Many Veterans with KOA also experience depressive symptoms, which can worsen pain, reduce motivation to exercise, and make recovery more difficult. This study w...
What is the current status of trial NCT07649291?
This trial is currently not yet recruiting. It is a Phase 2 study. The enrollment target is 102 participants. The study started on 2027-03-01. Estimated completion is 2032-09-01.
What interventions are being tested in trial NCT07649291?
The interventions under investigation include: Placebo (DRUG), Duloxetine (DRUG), Exercise (BEHAVIORAL), PT referral (BEHAVIORAL).
Who is sponsoring clinical trial NCT07649291?
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 NCT07649291's enrollment target sits among peer trials
102 668th of 2000 higher than 1,329 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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