|
|
|
|
|
|
Sponsored by: |
Merck |
Information provided by: | Merck |
ClinicalTrials.gov Identifier: | NCT00601458 |
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.
Condition | Intervention | Phase |
Acute Pain |
Drug: pregabalin Drug: naproxen sodium Drug: Comparator: Placebo (unspecified) |
Phase I |
Drug Information available for: | Naproxen sodium Naproxen Pregabalin |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy 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 |
Estimated Enrollment: | 90 |
Study Start Date: | July 2007 |
Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Active Comparator
Arm 1: pregabalin
|
Drug: pregabalin
Patients will be randomized just prior to surgery to 1 of 3 study treatments: pregabalin (300 mg) treatment will be administered approximately 1 hour prior to surgery. Postoperatively, pregabalin (150 mg) will be dosed starting at 8 hours following T=0 and every 8 hours until 40 hours following T=0.
|
2: Active Comparator
Arm 2: naproxen sodium
|
Drug: naproxen sodium
Patients will be randomized just prior to surgery to 1 of 3 study treatments: naproxen sodium (550 mg) treatment will be administered approximately 1 hour prior to surgery. Postoperatively, naproxen sodium will be dosed starting 12 hours following T=0 and every 12 hours until 36 hours following T=0.
|
3: Placebo Comparator
Arm 3: Pbo
|
Drug: Comparator: Placebo (unspecified)
Patients will be randomized just prior to surgery to 1 of 3 study treatments: placebo treatment will be administered approximately 1 hour prior to surgery. Postoperatively, placebo will be dosed starting at 8 hours following T=0 and every 8 hours until 40 hours following T=0.
|
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences ) |
Study ID Numbers: | 2007_661, 063 |
First Received: | January 15, 2008 |
Last Updated: | March 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00601458 |
Health Authority: | United States: Food and Drug Administration |
|
|
|
|