CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 240 enrolled
Drug / intervention
Orphenadrine +3 moredrug
Likely dose
Orphenadrine 100 mg orally twice daily for 7 days, or Methocarbamol 750 mg (1-2 tablets) orally three times daily for 7 days, or Naproxen 500 mg orally twice daily for 7 daysAI-extracted
Key inclusion· 4
  • Low back pain duration of 2 weeks or less
  • No trauma to the low back in the previous month
  • No radicular (nerve root) symptoms
  • No history of chronic low back pain or only infrequent prior episodes
Key exclusion· 3
  • Known allergies or contraindications to study medications
  • Unable to complete follow-up visits
  • Chronic pain syndrome diagnosis

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02665286
NCT02665286Phase 4Completed

Methocarbamol and Orphenadrine for Acute, Non-traumatic, Non-radicular Low Back Pain: A Randomized, Placebo Controlled, 3-armed Study

Montefiore Medical Center·interventional·Posted Jan 27, 2016·Updated Jun 26, 2018

In Brief

A Phase 4 clinical trial evaluating Orphenadrine, Methocarbamol, and 2 other interventions for Low Back Pain. Completed, enrolled 240 participants across 1 site.

Detailed Summary

Low back pain is a common cause of visit to emergency department. It is not clear if skeletal muscle relaxants are of benefit for patients with acute low back pain. This is a randomized study to determine if skeletal muscle relaxants, when combined with naproxen, improve outcomes more than naproxen alone

Study Details

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

Timeline

Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedJan 27, 2016
Enrollment StartMar 1, 2016
Primary CompletionApr 1, 2017
Study CompletionMay 1, 2017
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 10.4 years ago

Interventions

Orphenadrinedrug

Orphenadrine 100mg PO BID x 7 days

Methocarbamoldrug

Methocarbamol 750mg 1-2 tabs po TID x 7 days

Naproxendrug

Naproxen 500mg PO BID x 7 days

Placebodrug

1/2 of placebo packages will be dosed to match methocarbamol: 1-2 tabs po TID x 7days 1/2 of placebo packages will be dosed to match orphenadrine: 1 tab PO BID x 7 days