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

NCT02814565 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2019-04-08

Study results available
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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.

Conditions

Interventions

DRUG

Cyclobenzaprine HCl

Cyclobenzaprine HCl extended-release capsules

DRUG

Placebo

Cyclobenzaprine HCl extended release placebo-matching capsules

Sponsors & Collaborators

Principal Investigators

  • Medical Director Clinical Science · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-12
Primary Completion
2017-02-10
Completion
2017-03-14

Countries

  • Russia

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02814565 on ClinicalTrials.gov