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Tracking Information | |||||
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First Received Date † | January 15, 2008 | ||||
Last Updated Date | February 5, 2009 | ||||
Start Date † | July 2007 | ||||
Current Primary Outcome Measures † |
Reduction in the total dose of PCA hydromorphone use [ Time Frame: First 24 hours following surgery ] [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00601458 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † |
Time to first request of PCA hydromorphone [ Time Frame: First 24 hours following surgery ] [ Designated as safety issue: No ] | ||||
Original Secondary Outcome Measures † | Same as current | ||||
Descriptive Information | |||||
Brief Title † | Bunionectomy Study | ||||
Official Title † | A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Effect of Pregabalin and Naproxen Sodium on Postoperative Pain After Bunionectomy | ||||
Brief Summary | We are interested in whether bunionectomy can be used as a model to study the treatment of acute pain. It has been used to study the effect of Non-Steroidal Anti-inflammatory (NSAIDS) medications (such as ibuprofen) and other pain relieving drugs. We are interested to know if this model is useful to study other drugs for the treatment of acute pain. The other drugs being tested in this study are pregabalin and naproxen sodium. These drugs are approved for use by the Food and Drug Administration (FDA). This study is designed to test whether these two drugs are effective in treating pain after a bunionectomy. |
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Detailed Description | |||||
Study Phase | Phase I | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study | ||||
Condition † | Acute Pain | ||||
Intervention † |
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Study Arms / Comparison Groups |
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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 † | 90 | ||||
Completion Date | February 2008 | ||||
Primary Completion Date | January 2008 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years to 65 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | |||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00601458 | ||||
Responsible Party | Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc. | ||||
Secondary IDs †† | 063 | ||||
Study Sponsor † | Merck | ||||
Collaborators †† | |||||
Investigators † |
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Information Provided By | Merck | ||||
Verification Date | February 2009 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |