Official Title: “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 Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

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.

Intervention(s) in this Clinical Trial

• Drug: cyclobenzaprine hydrochloride

Primary Measures

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

Secondary Measures

• 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.

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

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

Overall Clinical Trial Officials and Contacts

McNeil Consumer & Specialty Pharmaceuticals Clinical Trial Study Director McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.  

Information obtained from ClinicalTrials.gov on August 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00246389

Study ID Number: CR002884

ClinicalTrials.gov Identifier: NCT00246389

Health Authority: United States: Institutional Review Board