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
Results First Received: September 10, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Low Back Pain
Interventions: Drug: celecoxib
Drug: tramadol HCL

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Celecoxib 200 mg capsules two times a day (BID) for 6 weeks
Tramadol HCL 50 mg capsules four times a day (QID) for 6 weeks

Participant Flow:   Overall Study
    Celecoxib     Tramadol HCL  
STARTED     398     404  
Received Treatment     396     396  
COMPLETED     342     294  
NOT COMPLETED     56     110  
Adverse Event                 21                 59  
Lack of Efficacy                 4                 7  
Lost to Follow-up                 13                 10  
Unknown                 9                 14  
Withdrawal by Subject                 7                 12  
Randomized But Did Not Receive Treatment                 2                 8  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Celecoxib 200 mg capsules two times a day (BID) for 6 weeks
Tramadol HCL 50 mg capsules four times a day (QID) for 6 weeks
Total Total of all reporting groups

Baseline Measures
    Celecoxib     Tramadol HCL     Total  
Number of Participants  
[units: participants]
  396     396     792  
Age, Customized  
[units: participants]
     
18 to 44 years     164     167     331  
45 to 64 years     191     182     373  
> = 65 years     41     47     88  
Gender  
[units: participants]
     
Female     237     213     450  
Male     159     183     342  



  Outcome Measures
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1.  Primary:   Treatment Responders Based on the Numerical Rating Scale-Pain (NRS-Pain)   [ Time Frame: Week 6 or Early Termination (ET) ]

2.  Secondary:   Change From Baseline in Severity of Chronic Low Back Pain as Measured by NRS-Pain   [ Time Frame: Baseline, Week 6/ET ]

3.  Secondary:   Change From Baseline in Severity of Low Back Pain as Measured by Visual Analogue Scale (VAS)   [ Time Frame: Baseline, Week 6/ET ]

4.  Secondary:   Patient's Global Assessment of Disease Activity   [ Time Frame: Week 6/ET ]

5.  Secondary:   Physician's Global Assessment of Disease Activity   [ Time Frame: Week 6/ET ]

6.  Secondary:   Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score   [ Time Frame: Baseline, Week 6/ET ]

7.  Secondary:   Change From Baseline in Modified Brief Pain Inventory (m-BPI-sf)   [ Time Frame: Baseline, Week 6/ET ]

8.  Secondary:   Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale   [ Time Frame: Baseline, Week 6/ET ]

9.  Secondary:   Number of Subjects With Change From Baseline in MOS Optimal Sleep Scale Scores   [ Time Frame: Baseline, Week 6/ET ]

10.  Secondary:   Change From Baseline in Work Limitations Questionnaire (WLQ)   [ Time Frame: Baseline, Week 6/ET ]

11.  Secondary:   Patient's Global Evaluation of Study Medication   [ Time Frame: Weeks 1, 3, and 6/ET ]

12.  Secondary:   Patient's Satisfaction Questionnaire (With Pain Relief Scale)   [ Time Frame: Week 6/ET ]

13.  Secondary:   Patient's Satisfaction Questionnaire (With Walking and Bending Ability Scale)   [ Time Frame: Week 6/ET ]

14.  Secondary:   Chronic Low Back Pain Responders Based on VAS, Patient's Global, and RMDQ   [ Time Frame: Week 6/ET ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.govCallCenter@pfizer.com


No publications provided


Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier: NCT00662558     History of Changes
Other Study ID Numbers: A3191338
Study First Received: December 6, 2007
Results First Received: September 10, 2009
Last Updated: October 21, 2009
Health Authority: United States: Food and Drug Administration