Bunionectomy Study (0000-063)

Phase 1

Completed

• Conditions: Acute Pain
• Interventions: Drug: pregabalin; Drug: naproxen sodium

• Registration Number: NCT00601458
• Lead Sponsor: Merck Sharp & Dohme LLC

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07
• Primary Completion: 2008-01
• Study Completion: 2008-01
• Study First Submitted: 2008-01-15
• Study First Submitted QC: 2008-01-25
• Study First Posted: 2008-01-28
• Results First Submitted: 2009-12-23
• Results First Submitted QC: 2010-03-23
• Results First Posted: 2010-04-08
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-23
• Last Update Posted: 2015-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 = 60 mL 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.)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1: Pregabalin 300 mg	pregabalin	-
Arm 2: naproxen sodium 550 mg	naproxen sodium	-

Primary Outcome Measures

Name	Time	Method
Total Patient Controlled Analgesic (PCA) Hydromorphone Consumption Over the 24 Hours Post-surgery	First 24 hours following surgery	Total dose (amount) of hydromorphone via patient controlled analgesic (PCA) pump required in the 24 hours post-surgery in each of the treatment arms: placebo, pregabalin 300 mg or naproxen 550 mg.

Secondary Outcome Measures

Name	Time	Method
Time to First Request of PCA Hydromorphone	First 24 hours following surgery	Time (in hours) to first patient controlled analgesic (PCA) pump use after surgery in each of the treatment arms: placebo, pregabalin 300 mg or naproxen 550 mg.