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

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 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
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
Experimental: celecoxib	Drug: celecoxib 200 mg capsules BID for 6 weeks
Active Comparator: tramadol	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

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

Keywords provided by Pfizer:

Chronic low back pain

Additional relevant MeSH terms:

Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Tramadol
Celecoxib
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics

Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Analgesics, Opioid
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on May 23, 2013