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

NCT ID: NCT00246389

Last Updated: 2011-02-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 1000 participants
• Study Classification: INTERVENTIONAL
• Study Completion Date: 2004-07-31

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

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.

Conditions

Pain; Spasm

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

cyclobenzaprine hydrochloride

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

INDUSTRY

Sponsor Role: lead

Principal Investigators

McNeil Consumer & Specialty Pharmaceuticals, a Division of Mc Neil-PPC, Inc. Clinical Trial

Role: STUDY_DIRECTOR

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

References

Childers MK, Borenstein D, Brown RL, Gershon S, Hale ME, Petri M, Wan GJ, Laudadio C, Harrison DD. Low-dose cyclobenzaprine versus combination therapy with ibuprofen for acute neck or back pain with muscle spasm: a randomized trial. Curr Med Res Opin. 2005 Sep;21(9):1485-93. doi: 10.1185/030079905X61938.

Reference Type: RESULT

PMID: 16197668 (View on PubMed)

Other Identifiers

CR002884

Identifier Type: -

Identifier Source: org_study_id