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

• Status: Completed
• Trial end date: 2004-07-01
• Target enrollment: 0
• Participant gender: All

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 800 mg (pain relief medication) taken three times a day, for the treatment of back or neck muscle pain with muscle spasm.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
• Treatments: Amitriptyline; Cyclobenzaprine; Ibuprofen

Criteria

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.