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.

Study NCT00662558 Information provided by Pfizer

First Received: December 6, 2007 Last Updated: October 21, 2009 History of Changes

Study Type:	Interventional
Study Design:	Randomized, Double Blind (Subject, Investigator), Parallel Assignment
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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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

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) [ Week 6 or Early Termination (ET) ]

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2. Secondary:

Change From Baseline in Severity of Chronic Low Back Pain as Measured by NRS-Pain [ Baseline, Week 6/ET ]

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3. Secondary:

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

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4. Secondary:

Patient's Global Assessment of Disease Activity [ Week 6/ET ]

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5. Secondary:

Physician's Global Assessment of Disease Activity [ Week 6/ET ]

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6. Secondary:

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

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7. Secondary:

Change From Baseline in Modified Brief Pain Inventory (m-BPI-sf) [ Baseline, Week 6/ET ]

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8. Secondary:

Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale [ Baseline, Week 6/ET ]

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9. Secondary:

Number of Subjects With Change From Baseline in MOS Optimal Sleep Scale Scores [ Baseline, Week 6/ET ]

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10. Secondary:

Change From Baseline in Work Limitations Questionnaire (WLQ) [ Baseline, Week 6/ET ]

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11. Secondary:

Patient's Global Evaluation of Study Medication [ Weeks 1, 3, and 6/ET ]

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12. Secondary:

Patient's Satisfaction Questionnaire (With Pain Relief Scale) [ Week 6/ET ]

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13. Secondary:

Patient's Satisfaction Questionnaire (With Walking and Bending Ability Scale) [ Week 6/ET ]

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14. Secondary:

Chronic Low Back Pain Responders Based on VAS, Patient's Global, and RMDQ [ Week 6/ET ]

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Serious Adverse Events

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Other Adverse Events

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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Pfizer has the right to review disclosures, requesting a delay of < 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), < 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.

Limitations and Caveats

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