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A Six Week Study Of The Pain Relieving Effects Of Celecoxib 200 Mg Twice Daily Compared To Tramadol 50 Mg Four Times Daily In Patients With Chronic Low Back Pain

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ClinicalTrials.gov Identifier: NCT00662558
Recruitment Status : Completed
First Posted : April 21, 2008
Results First Posted : November 23, 2009
Last Update Posted : November 23, 2009
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE December 6, 2007
First Posted Date  ICMJE April 21, 2008
Results First Submitted Date  ICMJE September 10, 2009
Results First Posted Date  ICMJE November 23, 2009
Last Update Posted Date November 23, 2009
Study Start Date  ICMJE January 2008
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 21, 2009)
Treatment Responders Based on the Numerical Rating Scale-Pain (NRS-Pain) [ Time Frame: Week 6 or Early Termination (ET) ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 17, 2008)
To compare the analgesic effectiveness of celecoxib and tramadol in subjects with Chronic Low Back Pain measured by the Numerical Rating Scale (NRS-Pain) at Week 6 [ Time Frame: 11/07/08 ]
Change History Complete list of historical versions of study NCT00662558 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 21, 2009)
  • Change From Baseline in Severity of Chronic Low Back Pain as Measured by NRS-Pain [ Time Frame: Baseline, Week 6/ET ]
  • Change From Baseline in Severity of Low Back Pain as Measured by Visual Analogue Scale (VAS) [ Time Frame: Baseline, Week 6/ET ]
  • Patient's Global Assessment of Disease Activity [ Time Frame: Week 6/ET ]
  • Physician's Global Assessment of Disease Activity [ Time Frame: Week 6/ET ]
  • Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score [ Time Frame: Baseline, Week 6/ET ]
  • Change From Baseline in Modified Brief Pain Inventory (m-BPI-sf) [ Time Frame: Baseline, Week 6/ET ]
  • Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale [ Time Frame: Baseline, Week 6/ET ]
  • Number of Subjects With Change From Baseline in MOS Optimal Sleep Scale Scores [ Time Frame: Baseline, Week 6/ET ]
  • Change From Baseline in Work Limitations Questionnaire (WLQ) [ Time Frame: Baseline, Week 6/ET ]
  • Patient's Global Evaluation of Study Medication [ Time Frame: Weeks 1, 3, and 6/ET ]
  • Patient's Satisfaction Questionnaire (With Pain Relief Scale) [ Time Frame: Week 6/ET ]
  • Patient's Satisfaction Questionnaire (With Walking and Bending Ability Scale) [ Time Frame: Week 6/ET ]
  • Chronic Low Back Pain Responders Based on VAS, Patient's Global, and RMDQ [ Time Frame: Week 6/ET ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 17, 2008)
To compare the effects of treatment with celecoxib 200 mg BID and tramadol hydrochloride 50 mg QID on improvement in functionality and quality of life in subjects with chronic low back pain [ Time Frame: 11/07/08 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Six Week Study Of The Pain Relieving Effects Of Celecoxib 200 Mg Twice Daily Compared To Tramadol 50 Mg Four Times Daily In Patients With Chronic Low Back Pain
Official Title  ICMJE A Six Week Double-Blind, Randomized, Multicenter Comparison Study Of The Analgesic Effectiveness Of Celecoxib 200 Mg BID Compared To Tramadol Hydrochloride 50 Mg QID In Subjects With Chronic Low Back Pain
Brief Summary To compare the analgesic effectiveness of celecoxib and tramadol in subjects with Chronic Low Back Pain measured by the Numerical Rating Scale (NRS-Pain) at Week 6
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Low Back Pain
Intervention  ICMJE
  • Drug: celecoxib
    200 mg capsules BID for 6 weeks
  • Drug: tramadol HCL
    50 mg capsules QID for 6 weeks
Study Arms  ICMJE
  • Experimental: celecoxib
    Intervention: Drug: celecoxib
  • Active Comparator: tramadol
    Intervention: Drug: tramadol HCL
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 18, 2008)
802
Original Estimated Enrollment  ICMJE
 (submitted: April 17, 2008)
776
Actual Study Completion Date  ICMJE September 2008
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • The subject presents with duration of chronic low back pain of > 3 months requiring regular use of analgesics (> 4 days/week), except for acetaminophen which cannot have been the sole analgesic used

Exclusion Criteria:

  • The subject has chronic low back pain, which is neurologic in etiology (i.e., radiculopathy, neuropathy, myelopathy)
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 NCT00662558
Other Study ID Numbers  ICMJE A3191338
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer Inc
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date October 2009

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