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NCT02646124 · ClinicalTrials.gov registry record · Phase 2
Diazepam Use With Standard Management for Acute Low Back Pain
A Phase 2 study, sponsored by Montefiore Medical Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 114
- Enrollment target
NCT02646124: Completed Phase 2 study, sponsored by Montefiore Medical Center.
NCT02646124 is a Phase 2 study that has completed, run by Montefiore Medical Center. The registered enrollment target is 114 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (14% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02646124, a Phase 2 study, has completed, sponsored by Montefiore Medical Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 114 participants
- Enrollment target
Study Summary
Given the poor pain and functional outcomes that persist beyond an Emergency Department (ED) visit for musculoskeletal low back pain (LBP), we propose a clinical trial to evaluate whether combining a benzodiazepine with an NSAID is more effective than nonsteroidal antiinflammatory drug (NSAID) monotherapy for the treatment of acute, non-traumatic, non-radicular low back pain.
Primary Outcome
The Roland Morris Disability Questionnaire (RMDQ) is a 24 item instrument that evaluates the impact of low back pain on one's daily life. It is most sensitive for patients with mild to moderate disability due to acute, sub-acute or chronic low back pain. Each question can be answered as either a "yes" or "no". The score ranges from 0 to 24 where a higher score reflects greater impairment and, therefore, worsening in the quality of life. The change in RMDQ is obtained by subtracting the RMDQ scor
Interventions
- DRUG Placebo
- DRUG Naproxen
- DRUG Diazepam
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 114 participants |
| Start Date | 2015-06 |
| Est. Completion | 2016-05 |
| Phase | Phase 2 |
What the finished NCT02646124 record still lists
NCT02646124 is an interventional study that assigns participants to a tested intervention. The registered 114 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 (14% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT02646124 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02646124 about?
NCT02646124 is a clinical study titled "Diazepam Use With Standard Management for Acute Low Back Pain". Given the poor pain and functional outcomes that persist beyond an Emergency Department (ED) visit for musculoskeletal low back pain (LBP), we propose a clinical trial to evaluate whether combining a benzodiazepine with an NSAID is more effective than nonsteroidal antiinflammatory drug (NSAID) monot...
What is the current status of trial NCT02646124?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 114 participants. The study started on 2015-06. Estimated completion is 2016-05.
What interventions are being tested in trial NCT02646124?
The interventions under investigation include: Placebo (DRUG), Naproxen (DRUG), Diazepam (DRUG).
Who is sponsoring clinical trial NCT02646124?
This trial is sponsored by Montefiore Medical Center, which has 345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02646124's enrollment target sits among peer trials
114 627th of 2000 higher than 1,370 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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