CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 180 enrolled
Drug / intervention
Cyclobenzaprine HCl +1 moredrug
Likely dose
Not stated in 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/NCT02814565
NCT02814565Phase 3Completed
CompareCT.gov

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

Takeda·interventional·Posted Jun 27, 2016·Updated Apr 8, 2019

In Brief

A Phase 3 clinical trial evaluating Cyclobenzaprine HCl and Placebo for Neck Pain and 2 related conditions. Completed, enrolled 180 participants across 10 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeck Pain, Back Pain, Spasm
CountriesRussia
Collaborators--

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedJun 27, 2016
Enrollment StartOct 12, 2016
Primary CompletionFeb 10, 2017
Study CompletionMar 14, 2017
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 10.0 years ago

Interventions

Cyclobenzaprine HCldrug

Cyclobenzaprine HCl extended-release capsules

Placebodrug

Cyclobenzaprine HCl extended release placebo-matching capsules