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

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.

Timeline

Start

2016-10-12

Primary completion

2017-02-10

Completion

2017-03-14

Outcome

Missed primary endpoint

registry analysis (superiority test); Cyclobenzaprine HCl 15 mg vs Placebo; p = 0.6179; Wilcoxon Rank Sum test NCT02814565 ↗

Drugs

Indications

No indication recorded.