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

Condition(s) targeted: Back Pain

Intervention: Tramadol Hydrochloride 50mg (Drug); Celebrex 200mg (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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.

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 design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study

Primary outcome: 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: 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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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)

Pfizer Investigational Site, Rio Piedras, Puerto Rico

Pfizer Investigational Site, Phoenix, Arizona, United States

Pfizer Investigational Site, Tucson, Arizona, United States

Pfizer Investigational Site, Scottsdale, Arizona, United States

Pfizer Investigational Site, Little Rock, Arkansas, United States

Pfizer Investigational Site, Long Beach, California, United States

Pfizer Investigational Site, Paramount, California, United States

Pfizer Investigational Site, Tustin, 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, San Francisco, California, United States

Pfizer Investigational Site, Oceanside, California, United States

Pfizer Investigational Site, La Mesa, California, United States

Pfizer Investigational Site, Colorado Springs, Colorado, United States

Pfizer Investigational Site, Boulder, Colorado, United States

Pfizer Investigational Site, Denver, Colorado, United States

Pfizer Investigational Site, Cos Cob, Connecticut, United States

Pfizer Investigational Site, Washington, 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, Woodstock, Georgia, United States

Pfizer Investigational Site, Decatur, Georgia, United States

Pfizer Investigational Site, Morton Grove, Illinois, United States

Pfizer Investigational Site, Libertyville, Illinois, United States

Pfizer Investigational Site, Overland Park, Kansas, United States

Pfizer Investigational Site, Arkansas City, Kansas, United States

Pfizer Investigational Site, Wichita, Kansas, United States

Pfizer Investigational Site, Madisonville, Kentucky, United States

Pfizer Investigational Site, Wheaton, Maryland, United States

Pfizer Investigational Site, Baltimore, Maryland, United States

Pfizer Investigational Site, Jackson, Mississippi, United States

Pfizer Investigational Site, St. Louis, Missouri, United States

Pfizer Investigational Site, Kansas City, 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, Columbia, South Carolina, United States

Pfizer Investigational Site, Charleston, South Carolina, United States

Pfizer Investigational Site, New Tazewell, Tennessee, United States

Pfizer Investigational Site, Johnson City, Tennessee, United States

Pfizer Investigational Site, San Antonio, Texas, United States

Pfizer Investigational Site, Austin, Texas, United States

Pfizer Investigational Site, San Angelo, Texas, United States

Pfizer Investigational Site, Arlington, Virginia, United States

Pfizer Investigational Site, Danville, Virginia, United States

To obtain contact information for a study center near you, click here.

Link to ClinicalStudyResults.org posting:

Starting date: March 2006
Last updated: March 21, 2008