Celebrex vs Tramadol in the Treatment of Chronic Lower Back Pain.
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|ClinicalTrials.gov Identifier: NCT00290901|
Recruitment Status : Completed
First Posted : February 13, 2006
Last Update Posted : March 3, 2021
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|Condition or disease||Intervention/treatment||Phase|
|Back Pain||Drug: Tramadol Hydrochloride 50mg Drug: Celebrex 200mg||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||754 participants|
|Intervention Model:||Parallel Assignment|
|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 Start Date :||March 2006|
|Actual Primary Completion Date :||December 2006|
- 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.
- 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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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- 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.
- The subject has chronic low back pain, which is neurologic in etiology (i.e., radiculopathy, neuropathy, myelopathy)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00290901
|Study Director:||Pfizer CT.gov Call Center||Pfizer|
|Responsible Party:||Pfizer's Upjohn has merged with Mylan to form Viatris Inc.|
|Other Study ID Numbers:||
|First Posted:||February 13, 2006 Key Record Dates|
|Last Update Posted:||March 3, 2021|
|Last Verified:||March 2021|
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