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”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

Primary:

• Reduction in the total dose of PCA hydromorphone use First 24 hours following surgery No

Secondary:

• Time to first request of PCA hydromorphone First 24 hours following surgery No

Inclusion Criteria:

• Patient is a man or woman between 18 and 65 years of age
• For Women of Child-bearing potential: woman who is currently not pregnant not nursing and who is willing to use a medically acceptable method of birth control from the time after the screening visit until completion of the follow-up visit
• Patient is scheduled to have a bunionectomy
• Patient must be willing to stay at the study site throughout the 48-hour observation period following surgery and is willing to complete a 2-week follow up
• Patient is capable of operating a Patient Controlled Analgesia device

Exclusion Criteria:

• Patient is being treated for a disease and has not been on a stable dose of medication for at least 2 weeks prior to surgery
• Patient has used or intends to use any of the medications that are prohibited by the protocol, which could interfere with the evaluation of the study drugs
• Patient has an estimated creatinine clearance of < or = 60mL per min
• Patient has a history of drug abuse or dependence, or patient has a positive urine drug screen
• Patient has a condition that prevents clear communication concerning pain perception (such as diabetic neuropathy, peripheral neuropathy, etc.)

Lead Sponsor: Merck

Overall Clinical Trial Officials and Contacts

Medical Monitor Study Director Merck  

Information obtained from ClinicalTrials.gov on July 18, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00601458

Study ID Number: 2007_661

ClinicalTrials.gov Identifier: NCT00601458

Health Authority: United States: Food and Drug Administration