NCT02814565

Cyclobenzaprine HCl Extended Release 15 mg Versus Placebo in Treatment of Cervical and/or Lower Back Pain Due to Muscle Spasms of Local Origin

A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Multicenter Trial to Study the Efficacy and Safety of Cyclobenzaprine HCl Extended Release (CER) 15 mg in Subjects With Acute Cervical and/or Lower Back Pain Due to Muscle Spasms of Local Origin

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 180 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to assess the effect of cyclobenzaprine hydrochloride (HCl) extended release (CER) 15 mg capsule once daily in participants with muscle spasms associated with acute painful musculoskeletal conditions.

Detailed description

The drug being tested in this study was cyclobenzaprine hydrochloride (HCl) extended-release (CER). CER was being tested to treat participants who had muscle spasms associated with acute painful musculoskeletal conditions. This study looked at medication helpfulness, relief from muscle spasms and pain, and improvement in range of motion and daily living activities. The study enrolled 180 participants. Participants were randomly assigned (by chance, like flipping a coin) to one of the two treatment groups which remained undisclosed to the participant and study doctor during the study: * CER 15 mg * Placebo (dummy inactive pill) - this was a capsule that looks like the study drug but had no active ingredient All participants were asked to take one capsule at the same time each day throughout the study. This multi-center trial was conducted in the Russian Federation. The overall time to participate in this study was up to 45 days. Participants made multiple visits to the clinic, and were contacted by telephone after the last dose of study drug for a follow-up assessment.

Conditions

• Neck Pain
• Back Pain
• Spasm

Interventions

Type	Name	Description
DRUG	Cyclobenzaprine HCl	Cyclobenzaprine HCl extended-release capsules
DRUG	Placebo	Cyclobenzaprine HCl extended release placebo-matching capsules

Timeline

• Start date: 2016-10-12
• Primary completion: 2017-02-10
• Completion: 2017-03-14
• First posted: 2016-06-27
• Last updated: 2019-04-08
• Results posted: 2019-04-08

Locations

10 sites across 1 country: Russia