Celebrex vs Tramadol in the Treatment of Chronic Lower Back Pain.
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
1 other identifier
interventional
754
2 countries
54
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
54 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 9, 2006
CompletedFirst Posted
Study publicly available on registry
February 13, 2006
CompletedStudy Start
First participant enrolled
March 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2006
CompletedMarch 3, 2021
March 1, 2021
9 months
February 9, 2006
March 1, 2021
Conditions
Outcome Measures
Primary Outcomes (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 Outcomes (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.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- The subject has chronic low back pain, which is neurologic in etiology (i.e., radiculopathy, neuropathy, myelopathy)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (54)
Pfizer Investigational Site
Phoenix, Arizona, United States
Pfizer Investigational Site
Scottsdale, Arizona, United States
Pfizer Investigational Site
Tucson, Arizona, United States
Pfizer Investigational Site
Little Rock, Arkansas, United States
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
Pfizer Investigational Site
Boulder, Colorado, United States
Pfizer Investigational Site
Colorado Springs, Colorado, United States
Pfizer Investigational Site
Denver, Colorado, United States
Pfizer Investigational Site
Cos Cob, Connecticut, United States
Pfizer Investigational Site
Washington D.C., District of Columbia, United States
Pfizer Investigational Site
Miami, Florida, United States
Pfizer Investigational Site
Pembroke Pines, Florida, United States
Pfizer Investigational Site
West Palm Beach, Florida, United States
Pfizer Investigational Site
Decatur, Georgia, United States
Pfizer Investigational Site
Woodstock, Georgia, United States
Pfizer Investigational Site
Libertyville, Illinois, United States
Pfizer Investigational Site
Morton Grove, Illinois, United States
Pfizer Investigational Site
Arkansas City, Kansas, United States
Pfizer Investigational Site
Overland Park, Kansas, United States
Pfizer Investigational Site
Wichita, Kansas, United States
Pfizer Investigational Site
Madisonville, Kentucky, United States
Pfizer Investigational Site
Baltimore, Maryland, United States
Pfizer Investigational Site
Wheaton, Maryland, United States
Pfizer Investigational Site
Jackson, Mississippi, United States
Pfizer Investigational Site
Kansas City, Missouri, United States
Pfizer Investigational Site
St Louis, Missouri, United States
Pfizer Investigational Site
Omaha, Nebraska, United States
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
Pfizer Investigational Site
Raleigh, North Carolina, United States
Pfizer Investigational Site
Medford, Oregon, United States
Pfizer Investigational Site
Portland, Oregon, United States
Pfizer Investigational Site
Camp Hill, Pennsylvania, United States
Pfizer Investigational Site
Duncansville, Pennsylvania, United States
Pfizer Investigational Site
Charleston, South Carolina, United States
Pfizer Investigational Site
Columbia, South Carolina, United States
Pfizer Investigational Site
Johnson City, Tennessee, United States
Pfizer Investigational Site
New Tazewell, Tennessee, United States
Pfizer Investigational Site
Austin, Texas, United States
Pfizer Investigational Site
San Angelo, Texas, United States
Pfizer Investigational Site
San Antonio, Texas, United States
Pfizer Investigational Site
Arlington, Virginia, United States
Pfizer Investigational Site
Danville, Virginia, United States
Pfizer Investigational Site
Rio Piedras, Puerto Rico
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 9, 2006
First Posted
February 13, 2006
Study Start
March 1, 2006
Primary Completion
December 1, 2006
Last Updated
March 3, 2021
Record last verified: 2021-03