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 - Full Text View

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00662558

Purpose

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

Condition	Intervention	Phase
Low Back Pain	Drug: celecoxib Drug: tramadol HCL	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Efficacy Study
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Back Pain

Drug Information available for: Tramadol Tramadol hydrochloride Celecoxib

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Treatment Responders Based on the Numerical Rating Scale-Pain (NRS-Pain) [ Time Frame: Week 6 or Early Termination (ET) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

Enrollment:	802
Study Start Date:	January 2008
Study Completion Date:	September 2008
Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
celecoxib: Experimental	Drug: celecoxib 200 mg capsules BID for 6 weeks
tramadol: Active Comparator	Drug: tramadol HCL 50 mg capsules QID for 6 weeks

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00662558

Show 60 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Link to ClinicalStudyResults.org posting: This link exits the ClinicalTrials.gov site

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

Keywords provided by Pfizer:

Chronic low back pain

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Pain
Signs and Symptoms
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Analgesics, Opioid
Celecoxib
Tramadol
Nervous System Diseases

Cyclooxygenase Inhibitors
Low Back Pain
Central Nervous System Depressants
Narcotics
Enzyme Inhibitors
Back Pain
Pharmacologic Actions
Analgesics, Non-Narcotic
Neurologic Manifestations
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 25, 2009