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...
Date First Received: February 9, 2006
Last Updated: March 21, 2008
Verified by: Pfizer, March 2008
Clinical Trial Phase: Phase 4 | Start Date: March 2006
Overall Status: Completed
Estimated Enrollment: 754
Brief Summary
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”
Condition Keyword(s):
Additional Keyword(s) Provided by Sponsor:
Intervention(s):
Condition MeSH Term(s), Assigned with an Experimental Algorithm:
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.
Study Type: Interventional
Study Design: Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Study Primary Completion Date: December 2006
Intervention(s) in this Clinical Trial
- Drug: Tramadol Hydrochloride 50mg
- Drug: Celebrex 200mg
Outcome Measures for this Clinical Trial
Primary Measures
- 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 Measures
- 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.
Criteria for Participation in this Clinical Trial
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 Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers
Clinical Trial Sponsor Information
Lead Sponsor: Pfizer
Overall Clinical Trial Officials and Contacts
Pfizer CT.gov Call Center Study Director Pfizer
Additional Information
Information obtained from ClinicalTrials.gov on September 02, 2010
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00290901
Study ID Number: A3191165
ClinicalTrials.gov Identifier: NCT00290901
Health Authority: United States: Food and Drug Administration
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