CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 114 enrolled
Drug / intervention
Naproxen +2 moredrug
Likely dose
Naproxen 500mgfrom 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/NCT02646124
NCT02646124Phase 3Completed
CompareCT.gov

Adding Diazepam to Standard Management of Acute, Non-radicular Low Back Pain. An Emergency Department Based Randomized Comparative Effectiveness Study

Montefiore Medical Center·interventional·Posted Jan 5, 2016·Updated Aug 1, 2018

In Brief

A Phase 3 clinical trial evaluating Naproxen, Placebo, and 1 other intervention for Low Back Pain. Completed, enrolled 114 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLow Back Pain
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedJan 5, 2016
Enrollment StartJun 1, 2015
Primary CompletionFeb 1, 2016
Study CompletionMay 1, 2016
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 10.5 years ago

Interventions

Naproxendrug

Naproxen 500mg by mouth two times a day, #20

Placebodrug

28 placebo capsules

Diazepamdrug

Diazepam 5mg capsules, 1-2 tabs by mouth two times a day, #28