Status:
COMPLETED
An Effectiveness and Safety Study of Cyclobenzaprine HCl Alone or in Combination With Ibuprofen for Acute Back or Neck Muscle Pain With Muscle Spasm
Lead Sponsor:
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Conditions:
Pain
Spasm
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
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 80...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2004
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT00246389
End Date
July 1 2004
Last Update
February 18 2011
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