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Tracking Information | |||||
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First Received Date † | February 9, 2006 | ||||
Last Updated Date | March 21, 2008 | ||||
Start Date † | March 2006 | ||||
Current Primary Outcome 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. | ||||
Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00290901 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome 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. | ||||
Original Secondary Outcome Measures † | Same as current | ||||
Descriptive Information | |||||
Brief Title † | Celebrex vs Tramadol in the Treatment of Chronic Lower 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 | 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. |
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Detailed Description | |||||
Study Phase | Phase IV | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study | ||||
Condition † | Back Pain | ||||
Intervention † |
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Study Arms / Comparison Groups | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Completed | ||||
Enrollment † | 754 | ||||
Completion Date | |||||
Primary Completion Date | December 2006 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts †† | |||||
Location Countries † | United States, Puerto Rico | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00290901 | ||||
Responsible Party | |||||
Secondary IDs †† | |||||
Study Sponsor † | Pfizer | ||||
Collaborators †† | |||||
Investigators † |
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Information Provided By | Pfizer | ||||
Verification Date | March 2008 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |