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NCT00290901 Clinical Trial

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

Back Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00290901
Other study ID # A3191165
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date March 2006

Study information
Verified date March 2021
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 754
Est. completion date
Est. primary completion date December 2006
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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)

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Tramadol Hydrochloride 50mg

• Celebrex 200mg

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

Sponsors (1)
Lead Sponsor Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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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