Neck Pain Clinical Trial
Official title:
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
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.
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.
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