Celebrex vs Tramadol in the Treatment of Chronic Lower Back Pain. - Full Text View

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00290901

Purpose

This study investigates if Celebrex is as effective as tramadol hydrochloride (Ultram) for patients with chronic low back pain, when administered over a 6-week period.

Condition	Intervention	Phase
Back Pain	Drug: Tramadol Hydrochloride 50mg Drug: Celebrex 200mg	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, 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:

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.

Secondary Outcome Measures:

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.

Estimated Enrollment:	754
Study Start Date:	March 2006
Primary Completion Date:	December 2006 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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: NCT00290901

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Locations

United States, Arizona
Pfizer Investigational Site
Phoenix, Arizona, United States
Pfizer Investigational Site
Tucson, Arizona, United States
Pfizer Investigational Site
Scottsdale, Arizona, United States
United States, Arkansas
Pfizer Investigational Site
Little Rock, Arkansas, United States
United States, California
Pfizer Investigational Site
Long Beach, California, United States
Pfizer Investigational Site
Paramount, California, United States
Pfizer Investigational Site
San Francisco, California, United States
Pfizer Investigational Site
Vista, California, United States
Pfizer Investigational Site
Anaheim, California, United States
Pfizer Investigational Site
Sacramento, California, United States
Pfizer Investigational Site
San Francisco, California, United States
Pfizer Investigational Site
San Luis Obispo, California, United States
Pfizer Investigational Site
Tustin, California, United States
Pfizer Investigational Site
Oceanside, California, United States
Pfizer Investigational Site
La Mesa, California, United States
United States, Colorado
Pfizer Investigational Site
Colorado Springs, Colorado, United States
Pfizer Investigational Site
Boulder, Colorado, United States
Pfizer Investigational Site
Denver, Colorado, United States
United States, Connecticut
Pfizer Investigational Site
Cos Cob, Connecticut, United States
United States, District of Columbia
Pfizer Investigational Site
Washington, District of Columbia, United States
United States, Florida
Pfizer Investigational Site
Miami, Florida, United States
Pfizer Investigational Site
Pembroke Pines, Florida, United States
Pfizer Investigational Site
West Palm Beach, Florida, United States
United States, Georgia
Pfizer Investigational Site
Woodstock, Georgia, United States
Pfizer Investigational Site
Decatur, Georgia, United States
United States, Illinois
Pfizer Investigational Site
Morton Grove, Illinois, United States
Pfizer Investigational Site
Libertyville, Illinois, United States
United States, Kansas
Pfizer Investigational Site
Overland Park, Kansas, United States
Pfizer Investigational Site
Arkansas City, Kansas, United States
Pfizer Investigational Site
Wichita, Kansas, United States
United States, Kentucky
Pfizer Investigational Site
Madisonville, Kentucky, United States
United States, Maryland
Pfizer Investigational Site
Wheaton, Maryland, United States
Pfizer Investigational Site
Baltimore, Maryland, United States
United States, Mississippi
Pfizer Investigational Site
Jackson, Mississippi, United States
United States, Missouri
Pfizer Investigational Site
St. Louis, Missouri, United States
Pfizer Investigational Site
Kansas City, Missouri, United States
United States, Nebraska
Pfizer Investigational Site
Omaha, Nebraska, United States
United States, New York
Pfizer Investigational Site
Brooklyn, New York, United States
Pfizer Investigational Site
New York, New York, United States
Pfizer Investigational Site
Rochester, New York, United States
United States, North Carolina
Pfizer Investigational Site
Raleigh, North Carolina, United States
United States, Oregon
Pfizer Investigational Site
Medford, Oregon, United States
Pfizer Investigational Site
Portland, Oregon, United States
United States, Pennsylvania
Pfizer Investigational Site
Camp Hill, Pennsylvania, United States
Pfizer Investigational Site
Duncansville, Pennsylvania, United States
United States, South Carolina
Pfizer Investigational Site
Columbia, South Carolina, United States
Pfizer Investigational Site
Charleston, South Carolina, United States
United States, Tennessee
Pfizer Investigational Site
New Tazewell, Tennessee, United States
Pfizer Investigational Site
Johnson City, Tennessee, United States
United States, Texas
Pfizer Investigational Site
San Antonio, Texas, United States
Pfizer Investigational Site
Austin, Texas, United States
Pfizer Investigational Site
San Angelo, Texas, United States
United States, Virginia
Pfizer Investigational Site
Arlington, Virginia, United States
Pfizer Investigational Site
Danville, Virginia, United States
Puerto Rico
Pfizer Investigational Site
Rio Piedras, Puerto Rico

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

Study ID Numbers:	A3191165
Study First Received:	February 9, 2006
Last Updated:	March 21, 2008
ClinicalTrials.gov Identifier:	NCT00290901 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Celecoxib
Molecular Mechanisms of Pharmacological Action
Tramadol
Cyclooxygenase Inhibitors
Nervous System Diseases
Physiological Effects of Drugs
Central Nervous System Depressants
Enzyme Inhibitors
Narcotics
Pain
Back Pain

Pharmacologic Actions
Signs and Symptoms
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Neurologic Manifestations
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on November 22, 2009