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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

NCT00246389 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1000

Last updated 2011-02-18

No results posted yet for this study

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.

Conditions

Interventions

DRUG

cyclobenzaprine hydrochloride

Sponsors & Collaborators

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

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Completion
2004-07-31

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00246389 on ClinicalTrials.gov