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

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

About this trial

Last updated 14 years ago

Study ID

CR002884

Status

Completed

Type

Interventional

Phase

Phase 4

Placebo

No

Accepting

18-75 Years
18 to 65 Years
All
All

Not accepting

Not accepting
Healthy Volunteers

What is this trial about?

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.

What are the participation requirements?

Yes

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.)

No

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.