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

Condition(s) targeted: Spasm; Pain

Intervention: cyclobenzaprine hydrochloride (Drug)

Phase: Phase 4

Status: Completed

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

Official(s) and/or principal investigator(s):
McNeil Consumer & Specialty Pharmaceuticals Clinical Trial, Study Director, Affiliation: McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

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.

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

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

Primary outcome: Subject-rated global impression of change from baseline, after seven days of treatment

Secondary outcome: 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.

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 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.

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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

Ending date: July 2004
Last updated: May 11, 2007