A Six Week Study Of The Pain Relieving Effects Of Celecoxib 200 Mg Twice Daily Compared To Tramadol 50 Mg Four Times Daily In Patients With Chronic Low Back Pain

Condition(s) targeted: Back Pain

Intervention: celecoxib (Drug); tramadol HCL (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Pfizer

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

Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021

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

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 (Subject, Investigator), 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 CT.gov Call Center, Phone: 1-800-718-1021

Pfizer Investigational Site, Birmingham, Alabama 35242, United States; Recruiting

Pfizer Investigational Site, Birmingham, Alabama 35126, United States; Recruiting

Pfizer Investigational Site, Birmingham, Alabama 35235, United States; Recruiting

Pfizer Investigational Site, Phoenix, Arizona 85023, United States; Recruiting

Pfizer Investigational Site, Little Rock, Arkansas 72205, United States; Recruiting

Pfizer Investigational Site, Oceanside, California 92056, United States; Recruiting

Pfizer Investigational Site, Sacramento, California 95823, United States; Recruiting

Pfizer Investigational Site, Anaheim, California 92801, United States; Recruiting

Pfizer Investigational Site, Long Beach, California 90806, United States; Recruiting

Pfizer Investigational Site, Wildomar, California 92595, United States; Recruiting

Pfizer Investigational Site, Sacramento, California 95825, United States; Recruiting

Pfizer Investigational Site, Boulder, Colorado 80304, United States; Recruiting

Pfizer Investigational Site, Colorado Springs, Colorado 80904, United States; Recruiting

Pfizer Investigational Site, Denver, Colorado 80220, United States; Recruiting

Pfizer Investigational Site, Cos Cob, Connecticut 06807, United States; Recruiting

Pfizer Investigational Site, Jacksonville, Florida 32257, United States; Recruiting

Pfizer Investigational Site, West Palm Beach, Florida 33409, United States; Recruiting

Pfizer Investigational Site, Pinellas Park, Florida 33781, United States; Recruiting

Pfizer Investigational Site, Jacksonville, Florida 32216, United States; Recruiting

Pfizer Investigational Site, Woodstock, Georgia 30189, United States; Recruiting

Pfizer Investigational Site, Decatur, Georgia 30033, United States; Not yet recruiting

Pfizer Investigational Site, Wichita, Kansas 67206, United States; Recruiting

Pfizer Investigational Site, Wichita, Kansas 67214, United States; Recruiting

Pfizer Investigational Site, Baton Rouge, Louisiana 70809, United States; Recruiting

Pfizer Investigational Site, Baltimore, Maryland 21218, United States; Recruiting

Pfizer Investigational Site, Columbia, Maryland 21045, United States; Recruiting

Pfizer Investigational Site, Wheaton, Maryland 20902, United States; Recruiting

Pfizer Investigational Site, Rockville, Maryland 20852, United States; Recruiting

Pfizer Investigational Site, St. Paul, Minnesota 55108, United States; Recruiting

Pfizer Investigational Site, Jackson, Mississippi 39202, United States; Recruiting

Pfizer Investigational Site, St. Louis, Missouri 63141, United States; Recruiting

Pfizer Investigational Site, Springfield, Missouri 65807, United States; Recruiting

Pfizer Investigational Site, Omaha, Nebraska 68134, United States; Recruiting

Pfizer Investigational Site, New York, New York 10022-1009, United States; Recruiting

Pfizer Investigational Site, New Windsor, New York 12553, United States; Recruiting

Pfizer Investigational Site, Williamsville, New York 14221, United States; Recruiting

Pfizer Investigational Site, Rochester, New York 14618, United States; Recruiting

Pfizer Investigational Site, Portland, Oregon 97219, United States; Recruiting

Pfizer Investigational Site, Bridgeville, Pennsylvania 15017, United States; Recruiting

Pfizer Investigational Site, Camp Hill, Pennsylvania 17011, United States; Recruiting

Pfizer Investigational Site, Columbia, South Carolina 29204, United States; Recruiting

Pfizer Investigational Site, North Charleston, South Carolina 29406, United States; Recruiting

Pfizer Investigational Site, New Tazewell, Tennessee 37825, United States; Recruiting

Pfizer Investigational Site, Johnson City, Tennessee 37601, United States; Recruiting

Pfizer Investigational Site, Kingsport, Tennessee 37660, United States; Recruiting

Pfizer Investigational Site, Collierville, Tennessee 38017, United States; Recruiting

Pfizer Investigational Site, Nashville, Tennessee 37205, United States; Not yet recruiting

Pfizer Investigational Site, Bristol, Tennessee 37620, United States; Recruiting

Pfizer Investigational Site, San Antonio, Texas 78217, United States; Recruiting

Pfizer Investigational Site, Austin, Texas 78705, United States; Recruiting

Pfizer Investigational Site, San Antonio, Texas 78229, United States; Recruiting

Pfizer Investigational Site, Dallas, Texas 75240, United States; Recruiting

Pfizer Investigational Site, Grapevine, Texas 76051, United States; Recruiting

Pfizer Investigational Site, Lake Jackson, Texas 77566, United States; Recruiting

Pfizer Investigational Site, Houston, Texas 77074, United States; Recruiting

Pfizer Investigational Site, Beaumont, Texas 77701, United States; Recruiting

Pfizer Investigational Site, Beaumont, Texas 77706, United States; Recruiting

Pfizer Investigational Site, Dallas, Texas 75230, United States; Recruiting

Pfizer Investigational Site, San Angelo, Texas 76904, United States; Recruiting

Pfizer Investigational Site, Salt Lake City, Utah 84107, United States; Recruiting

Pfizer Investigational Site, Richmond, Virginia 23294, United States; Recruiting

Pfizer Investigational Site, Weber City, Virginia 24290, United States; Recruiting

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

Starting date: December 2007
Ending date: November 2008
Last updated: July 14, 2008