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Celebrex vs Tramadol in the Treatment of Chronic Lower Back Pain.

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ClinicalTrials.gov Identifier: NCT00290901
Recruitment Status : Completed
First Posted : February 13, 2006
Last Update Posted : March 24, 2008
Sponsor:
Information provided by:
Pfizer

Brief Summary:
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 or disease Intervention/treatment Phase
Back Pain Drug: Tramadol Hydrochloride 50mg Drug: Celebrex 200mg Phase 4

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Study Type : Interventional  (Clinical Trial)
Enrollment : 754 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : March 2006
Actual Primary Completion Date : December 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain




Primary Outcome Measures :
  1. 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 :
  1. 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.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00290901


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Locations
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United States, Arizona
Pfizer Investigational Site
Phoenix, Arizona, United States
Pfizer Investigational Site
Scottsdale, Arizona, United States
Pfizer Investigational Site
Tucson, Arizona, United States
United States, Arkansas
Pfizer Investigational Site
Little Rock, Arkansas, United States
United States, California
Pfizer Investigational Site
Anaheim, California, United States
Pfizer Investigational Site
La Mesa, California, United States
Pfizer Investigational Site
Long Beach, California, United States
Pfizer Investigational Site
Oceanside, California, United States
Pfizer Investigational Site
Paramount, 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
Vista, California, United States
United States, Colorado
Pfizer Investigational Site
Boulder, Colorado, United States
Pfizer Investigational Site
Colorado Springs, 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
Decatur, Georgia, United States
Pfizer Investigational Site
Woodstock, Georgia, United States
United States, Illinois
Pfizer Investigational Site
Libertyville, Illinois, United States
Pfizer Investigational Site
Morton Grove, Illinois, United States
United States, Kansas
Pfizer Investigational Site
Arkansas City, Kansas, United States
Pfizer Investigational Site
Overland Park, 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
Baltimore, Maryland, United States
Pfizer Investigational Site
Wheaton, Maryland, United States
United States, Mississippi
Pfizer Investigational Site
Jackson, Mississippi, United States
United States, Missouri
Pfizer Investigational Site
Kansas City, Missouri, United States
Pfizer Investigational Site
St. Louis, 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
Charleston, South Carolina, United States
Pfizer Investigational Site
Columbia, South Carolina, United States
United States, Tennessee
Pfizer Investigational Site
Johnson City, Tennessee, United States
Pfizer Investigational Site
New Tazewell, Tennessee, United States
United States, Texas
Pfizer Investigational Site
Austin, Texas, United States
Pfizer Investigational Site
San Angelo, Texas, United States
Pfizer Investigational Site
San Antonio, 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
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
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ClinicalTrials.gov Identifier: NCT00290901     History of Changes
Other Study ID Numbers: A3191165
First Posted: February 13, 2006    Key Record Dates
Last Update Posted: March 24, 2008
Last Verified: March 2008

Additional relevant MeSH terms:
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Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Tramadol
Celecoxib
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action