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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Pain, Spasm

Intervention / Treatment
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* Drug: cyclobenzaprine hydrochloride


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: cyclobenzaprine hydrochloride|nan|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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muscle spasm, cyclobenzaprine hydrochloride