An Effectiveness and Safety Study of Cyclobenzaprine HCl Alone or in Combination With Ibuprofen for Acute Back or Neck Muscle Pain With Muscle Spasm

February 17, 2011 updated by: McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Flexeril� (Cyclobenzaprine Hydrochloride) Community Based Study - An Evaluation of Cyclobenzaprine HCl Monotherapy and in Combination With Ibuprofen for Acute Back or Neck Muscle Pain With Muscle Spasm

The purpose of this study is to evaluate the effectiveness and safety of cyclobenzaprine HCl 5 mg (muscle spasm medication) taken three times a day, alone or in combination with ibuprofen 400 mg or 800 mg (pain relief medication) taken three times a day, for the treatment of back or neck muscle pain with muscle spasm.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The objective of this multicenter, randomized, open-label, parallel-group, one-week study is to evaluate the effectiveness and safety of cyclobenzaprine HCl 5 mg three times a day for one week, alone or in combination with ibuprofen 400 mg or 800 mg taken three times a day, for acute back or neck muscle pain with muscle spasm. The primary measurement of efficacy is the subject-rated global impression of change after seven days of treatment, compared to baseline. Safety assessments during the study include the monitoring of adverse events, and a physical examination, assessment of vital signs and medical history of any present illnesses conducted during the baseline visit. The study hypothesis is that there will not be a statistically significant difference in patient ratings of global impression of change, muscle spasm, muscle pain, medication helpfulness, and functional ability, between the cyclobenzaprine HCl monotherapy group versus the cyclobenzaprine HCl/ibuprofen 400 mg and cyclobenzaprine HCl/ibuprofen 800 mg groups, for the treatment for acute back or neck muscle pain with spasm. Patients receive cyclobenzaprine HCl 5 mg administered orally three times a day for one week, or cyclobenzaprine HCl 5 mg with ibuprofen 400 mg administered orally three times a day for one week, or cyclobenzaprine HCl 5 mg with ibuprofen 800 mg administered orally three times a day for one week.

Study Type

Interventional

Enrollment (Actual)

1000

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Experiencing neck or back pain for no more than 14 days
  • Physician rating of the muscle spasm of the neck or back region as mild, moderate or severe
  • Ability to discontinue all muscle relaxants, NSAIDs (anti-inflammatory drugs) and pain relievers, other than the study medications during the 7-day treatment period. (Cardioprotective doses of aspirin (<= 325 mg / day) may be taken.)

Exclusion Criteria:

  • History of physician-diagnosed musculoskeletal neck or back muscle spasms within 12 months prior to the study
  • neck or back pain radiating into the arms or legs
  • history of serious medical conditions
  • taken a narcotic or muscle relaxant within 12 hours of the baseline physician visit
  • allergies to aspirin, NSAIDs or cyclobenzaprine HCl.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Subject-rated global impression of change from baseline, after seven days of treatment

Secondary Outcome Measures

Outcome Measure
Subject global impression of change after 3 days; Proportion of responders after 3 and 7 days, Change from baseline in subject-rated pain intensity, muscle spasm intensity, functional ability, and medication helpfulness after 3 and 7 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Completion (Actual)

July 1, 2004

Study Registration Dates

First Submitted

October 28, 2005

First Submitted That Met QC Criteria

October 28, 2005

First Posted (Estimate)

October 30, 2005

Study Record Updates

Last Update Posted (Estimate)

February 18, 2011

Last Update Submitted That Met QC Criteria

February 17, 2011

Last Verified

February 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR002884

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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