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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

Primary Purpose

Pain, Spasm

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
cyclobenzaprine hydrochloride
Sponsored by
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring muscle spasm, cyclobenzaprine hydrochloride

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    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.

    Full Information

    First Posted
    October 28, 2005
    Last Updated
    February 17, 2011
    Sponsor
    McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00246389
    Brief Title
    An Effectiveness and Safety Study of Cyclobenzaprine HCl Alone or in Combination With Ibuprofen for Acute 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 Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    July 2004 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pain, Spasm
    Keywords
    muscle spasm, cyclobenzaprine hydrochloride

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    1000 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    cyclobenzaprine hydrochloride
    Primary Outcome Measure Information:
    Title
    Subject-rated global impression of change from baseline, after seven days of treatment
    Secondary Outcome Measure Information:
    Title
    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.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    McNeil Consumer & Specialty Pharmaceuticals, a Division of Mc Neil-PPC, Inc. Clinical Trial
    Organizational Affiliation
    McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    16197668
    Citation
    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.
    Results Reference
    result

    Learn more about this trial

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

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