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Trial record 15 of 50 for:    CYCLOBENZAPRINE

Comparison of Ibuprofen, Cyclobenzaprine, or Both for Acute Cervical Strain: A Randomized Clinical Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00790270
Recruitment Status : Completed
First Posted : November 13, 2008
Results First Posted : November 21, 2012
Last Update Posted : November 21, 2012
Sponsor:
Information provided by:
Stony Brook University

Tracking Information
First Submitted Date  ICMJE November 12, 2008
First Posted Date  ICMJE November 13, 2008
Results First Submitted Date  ICMJE October 19, 2009
Results First Posted Date  ICMJE November 21, 2012
Last Update Posted Date November 21, 2012
Study Start Date  ICMJE January 2003
Actual Primary Completion Date January 2004   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 22, 2012)
  • Pain [ Time Frame: Daily for 1 week ]
  • Use of Rescue Medications [ Time Frame: 24 hours ]
    the number of patients taking additional rescue medications beyond the study meds
Original Primary Outcome Measures  ICMJE
 (submitted: November 12, 2008)
Pain [ Time Frame: Daily for 1 week ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 22, 2012)
  • Time to Resumption of Work [ Time Frame: 1 week ]
  • Resumption of Work or School [ Time Frame: next day ]
    number of patients resuming regular activity the day following enrollment.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 12, 2008)
Time to Resumption of Work [ Time Frame: 1 week ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Ibuprofen, Cyclobenzaprine, or Both for Acute Cervical Strain: A Randomized Clinical Trial
Official Title  ICMJE Comparison of Ibuprofen, Cyclobenzaprine, or Both for Acute Cervical Strain: A Randomized Clinical Trial
Brief Summary The purpose of this study is to see whether the combination of a muscle relaxant and anti-inflammatory drug is more effective at relieving pain in patients with neck strains or whiplash than either of the two medications alone.
Detailed Description Muscle relaxants have been used extensively for neck and back pain since muscle spasm is thought to play a role in the cycle of pain and spasm. However, prior studies have conflicting results regarding their additive effect when given in addition to analgesics such as the NSAIDs. Because they have the potential to lead to adverse events their efficacy should be clearly demonstrated before their routine use.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Cervical Strain
Intervention  ICMJE
  • Drug: Cyclobenzaprine
    5 mg orally every 8 hours as needed
    Other Name: flexeril
  • Drug: Ibuprofen
    Ibuprofen 400 mg every 8 hours as needed
    Other Name: motrin, advil
  • Drug: Ibuprofen plus Cyclobenzaprine
    Ibuprofen 400 mg plus cyclobenzaprine 5 mg every 8 hours as needed
    Other Name: motrin or advil with flexeril
Study Arms  ICMJE
  • Active Comparator: Cyclobenzaprine
    Intervention: Drug: Cyclobenzaprine
  • Active Comparator: Ibuprofen
    Intervention: Drug: Ibuprofen
  • Experimental: Ibuprophen plus Cyclobenzaprine
    Intervention: Drug: Ibuprofen plus Cyclobenzaprine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 12, 2008)
61
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2004
Actual Primary Completion Date January 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • neck pain within 24 hours of injury

Exclusion Criteria:

  • Children, allergy or contraindication to any of the study drugs
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00790270
Other Study ID Numbers  ICMJE SB2003-1234
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Adam Singer, MD, Stony Brook University
Study Sponsor  ICMJE Stony Brook University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: adam singer, md Stony Brook University
PRS Account Stony Brook University
Verification Date October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP