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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00662558
First received: December 6, 2007
Last updated: October 21, 2009
Last verified: October 2009

December 6, 2007
October 21, 2009
January 2008
September 2008   (final data collection date for primary outcome measure)
Treatment Responders Based on the Numerical Rating Scale-Pain (NRS-Pain) [ Time Frame: Week 6 or Early Termination (ET) ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00662558 on ClinicalTrials.gov Archive Site
  • Change From Baseline in Severity of Chronic Low Back Pain as Measured by NRS-Pain [ Time Frame: Baseline, Week 6/ET ] [ Designated as safety issue: No ]
  • Change From Baseline in Severity of Low Back Pain as Measured by Visual Analogue Scale (VAS) [ Time Frame: Baseline, Week 6/ET ] [ Designated as safety issue: No ]
  • Patient's Global Assessment of Disease Activity [ Time Frame: Week 6/ET ] [ Designated as safety issue: No ]
  • Physician's Global Assessment of Disease Activity [ Time Frame: Week 6/ET ] [ Designated as safety issue: No ]
  • Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score [ Time Frame: Baseline, Week 6/ET ] [ Designated as safety issue: No ]
  • Change From Baseline in Modified Brief Pain Inventory (m-BPI-sf) [ Time Frame: Baseline, Week 6/ET ] [ Designated as safety issue: No ]
  • Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale [ Time Frame: Baseline, Week 6/ET ] [ Designated as safety issue: No ]
  • Number of Subjects With Change From Baseline in MOS Optimal Sleep Scale Scores [ Time Frame: Baseline, Week 6/ET ] [ Designated as safety issue: No ]
  • Change From Baseline in Work Limitations Questionnaire (WLQ) [ Time Frame: Baseline, Week 6/ET ] [ Designated as safety issue: No ]
  • Patient's Global Evaluation of Study Medication [ Time Frame: Weeks 1, 3, and 6/ET ] [ Designated as safety issue: No ]
  • Patient's Satisfaction Questionnaire (With Pain Relief Scale) [ Time Frame: Week 6/ET ] [ Designated as safety issue: No ]
  • Patient's Satisfaction Questionnaire (With Walking and Bending Ability Scale) [ Time Frame: Week 6/ET ] [ Designated as safety issue: No ]
  • Chronic Low Back Pain Responders Based on VAS, Patient's Global, and RMDQ [ Time Frame: Week 6/ET ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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
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

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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Low Back Pain
  • Drug: celecoxib
    200 mg capsules BID for 6 weeks
  • Drug: tramadol HCL
    50 mg capsules QID for 6 weeks
  • Experimental: celecoxib
    Intervention: Drug: celecoxib
  • Active Comparator: tramadol
    Intervention: Drug: tramadol HCL
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
802
September 2008
September 2008   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00662558
A3191338
No
Director, Clinical Trial Disclosure Group, Pfizer Inc
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2009

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