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Clinical Trial Name - A Six Week Study Of The Pain Relieving Effects Of Celecoxib 200 Mg Twice Daily Compared To Tramado
| Original Study ID : A3191338 |
| NCT ID : NCT00662558 |
| Brief Title : 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 |
| 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 |
| Brief Summary : 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 |
| Source : Pfizer |
| Overall Status : Completed |
| Start Date : January 2008 |
| End Date : September 2008 |
| Completion Date : September 2008 |
| Official Title : Phase 4 |
| Phase : Interventional |
| Study Design : Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Efficacy Study |
| Enrollment : 802 |
| Verification Date : November 2008 |
| First Received Date : December 6, 2007 |
| Trial Eligibility |
| 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) |
| Gender : Both |
| Minimum Age : 18 Years |
| Maximum Age : N/A |
| Healthy Volunteers : No |
| Facilities |
| Facility Name : Pfizer Investigational Site |
| City : Birmingham |
| State : Alabama |
| Zip Code : 35242 |
| Country : United States |
| Facility Name : Pfizer Investigational Site |
| City : Birmingham |
| State : Alabama |
| Zip Code : 35126 |
| Country : United States |
| Facility Name : Pfizer Investigational Site |
| City : Birmingham |
| State : Alabama |
| Zip Code : 35235 |
| Country : United States |
| Facility Name : Pfizer Investigational Site |
| City : Phoenix |
| State : Arizona |
| Zip Code : 85023 |
| Country : United States |
| Facility Name : Pfizer Investigational Site |
| City : Little Rock |
| State : Arkansas |
| Zip Code : 72205 |
| Country : United States |
| Facility Name : Pfizer Investigational Site |
| City : Oceanside |
| State : California |
| Zip Code : 92056 |
| Country : United States |
| Facility Name : Pfizer Investigational Site |
| City : Sacramento |
| State : California |
| Zip Code : 95823 |
| Country : United States |
| Facility Name : Pfizer Investigational Site |
| City : Anaheim |
| State : California |
| Zip Code : 92801 |
| Country : United States |
| Facility Name : Pfizer Investigational Site |
| City : Long Beach |
| State : California |
| Zip Code : 90806 |
| Country : United States |
| Facility Name : Pfizer Investigational Site |
| City : Wildomar |
| State : California |
| Zip Code : 92595 |
| Country : United States |
| Facility Name : Pfizer Investigational Site |
| City : Sacramento |
| State : California |
| Zip Code : 95825 |
| Country : United States |
| Facility Name : Pfizer Investigational Site |
| City : Boulder |
| State : Colorado |
| Zip Code : 80304 |
| Country : United States |
| Facility Name : Pfizer Investigational Site |
| City : Colorado Springs |
| State : Colorado |
| Zip Code : 80904 |
| Country : United States |
| Facility Name : Pfizer Investigational Site |
| City : Denver |
| State : Colorado |
| Zip Code : 80220 |
| Country : United States |
| Facility Name : Pfizer Investigational Site |
| City : Cos Cob |
| State : Connecticut |
| Zip Code : 06807 |
| Country : United States |
| Facility Name : Pfizer Investigational Site |
| City : Jacksonville |
| State : Florida |
| Zip Code : 32257 |
| Country : United States |
| Facility Name : Pfizer Investigational Site |
| City : West Palm Beach |
| State : Florida |
| Zip Code : 33409 |
| Country : United States |
| Facility Name : Pfizer Investigational Site |
| City : Pinellas Park |
| State : Florida |
| Zip Code : 33781 |
| Country : United States |
| Facility Name : Pfizer Investigational Site |
| City : Jacksonville |
| State : Florida |
| Zip Code : 32216 |
| Country : United States |
| Facility Name : Pfizer Investigational Site |
| City : Woodstock |
| State : Georgia |
| Zip Code : 30189 |
| Country : United States |
| Facility Name : Pfizer Investigational Site |
| City : Wichita |
| State : Kansas |
| Zip Code : 67206 |
| Country : United States |
| Facility Name : Pfizer Investigational Site |
| City : Wichita |
| State : Kansas |
| Zip Code : 67214 |
| Country : United States |
| Facility Name : Pfizer Investigational Site |
| City : Baton Rouge |
| State : Louisiana |
| Zip Code : 70809 |
| Country : United States |
| Facility Name : Pfizer Investigational Site |
| City : Baltimore |
| State : Maryland |
| Zip Code : 21218 |
| Country : United States |
| Facility Name : Pfizer Investigational Site |
| City : Columbia |
| State : Maryland |
| Zip Code : 21045 |
| Country : United States |
| Facility Name : Pfizer Investigational Site |
| City : Wheaton |
| State : Maryland |
| Zip Code : 20902 |
| Country : United States |
| Facility Name : Pfizer Investigational Site |
| City : Rockville |
| State : Maryland |
| Zip Code : 20852 |
| Country : United States |
| Facility Name : Pfizer Investigational Site |
| City : St. Paul |
| State : Minnesota |
| Zip Code : 55108 |
| Country : United States |
| Facility Name : Pfizer Investigational Site |
| City : Jackson |
| State : Mississippi |
| Zip Code : 39202 |
| Country : United States |
| Facility Name : Pfizer Investigational Site |
| City : St. Louis |
| State : Missouri |
| Zip Code : 63141 |
| Country : United States |
| Facility Name : Pfizer Investigational Site |
| City : Springfield |
| State : Missouri |
| Zip Code : 65807 |
| Country : United States |
| Facility Name : Pfizer Investigational Site |
| City : Omaha |
| State : Nebraska |
| Zip Code : 68134 |
| Country : United States |
| Facility Name : Pfizer Investigational Site |
| City : New York |
| State : New York |
| Zip Code : 10022-1009 |
| Country : United States |
| Facility Name : Pfizer Investigational Site |
| City : New Windsor |
| State : New York |
| Zip Code : 12553 |
| Country : United States |
| Facility Name : Pfizer Investigational Site |
| City : Williamsville |
| State : New York |
| Zip Code : 14221 |
| Country : United States |
| Facility Name : Pfizer Investigational Site |
| City : Rochester |
| State : New York |
| Zip Code : 14618 |
| Country : United States |
| Facility Name : Pfizer Investigational Site |
| City : Portland |
| State : Oregon |
| Zip Code : 97219 |
| Country : United States |
| Facility Name : Pfizer Investigational Site |
| City : Bridgeville |
| State : Pennsylvania |
| Zip Code : 15017 |
| Country : United States |
| Facility Name : Pfizer Investigational Site |
| City : Camp Hill |
| State : Pennsylvania |
| Zip Code : 17011 |
| Country : United States |
| Facility Name : Pfizer Investigational Site |
| City : Columbia |
| State : South Carolina |
| Zip Code : 29204 |
| Country : United States |
| Facility Name : Pfizer Investigational Site |
| City : North Charleston |
| State : South Carolina |
| Zip Code : 29406 |
| Country : United States |
| Facility Name : Pfizer Investigational Site |
| City : New Tazewell |
| State : Tennessee |
| Zip Code : 37825 |
| Country : United States |
| Facility Name : Pfizer Investigational Site |
| City : Johnson City |
| State : Tennessee |
| Zip Code : 37601 |
| Country : United States |
| Facility Name : Pfizer Investigational Site |
| City : Kingsport |
| State : Tennessee |
| Zip Code : 37660 |
| Country : United States |
| Facility Name : Pfizer Investigational Site |
| City : Collierville |
| State : Tennessee |
| Zip Code : 38017 |
| Country : United States |
| Facility Name : Pfizer Investigational Site |
| City : Bristol |
| State : Tennessee |
| Zip Code : 37620 |
| Country : United States |
| Facility Name : Pfizer Investigational Site |
| City : San Antonio |
| State : Texas |
| Zip Code : 78217 |
| Country : United States |
| Facility Name : Pfizer Investigational Site |
| City : Austin |
| State : Texas |
| Zip Code : 78705 |
| Country : United States |
| Facility Name : Pfizer Investigational Site |
| City : San Antonio |
| State : Texas |
| Zip Code : 78229 |
| Country : United States |
| Facility Name : Pfizer Investigational Site |
| City : Dallas |
| State : Texas |
| Zip Code : 75240 |
| Country : United States |
| Facility Name : Pfizer Investigational Site |
| City : Grapevine |
| State : Texas |
| Zip Code : 76051 |
| Country : United States |
| Facility Name : Pfizer Investigational Site |
| City : Lake Jackson |
| State : Texas |
| Zip Code : 77566 |
| Country : United States |
| Facility Name : Pfizer Investigational Site |
| City : Houston |
| State : Texas |
| Zip Code : 77074 |
| Country : United States |
| Facility Name : Pfizer Investigational Site |
| City : Beaumont |
| State : Texas |
| Zip Code : 77701 |
| Country : United States |
| Facility Name : Pfizer Investigational Site |
| City : Beaumont |
| State : Texas |
| Zip Code : 77706 |
| Country : United States |
| Facility Name : Pfizer Investigational Site |
| City : Dallas |
| State : Texas |
| Zip Code : 75230 |
| Country : United States |
| Facility Name : Pfizer Investigational Site |
| City : San Angelo |
| State : Texas |
| Zip Code : 76904 |
| Country : United States |
| Facility Name : Pfizer Investigational Site |
| City : Salt Lake City |
| State : Utah |
| Zip Code : 84107 |
| Country : United States |
| Facility Name : Pfizer Investigational Site |
| City : Richmond |
| State : Virginia |
| Zip Code : 23294 |
| Country : United States |
| Facility Name : Pfizer Investigational Site |
| City : Weber City |
| State : Virginia |
| Zip Code : 24290 |
| Country : United States |
| OutComes |
| Primary OutComes |
| Measure : 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 |
| Time Frame : 6 weeks |
| Safety issue : No |
| Secondary OutComes |
| Measure : 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 |
| Time Frame : 6 weeks |
| Safety issue : No |
| Interventions |
| Type : Drug |
| Name : celecoxib |
| Description : 200 mg capsules BID for 6 weeks |
| Type : Drug |
| Name : tramadol HCL |
| Description : 50 mg capsules QID for 6 weeks |
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