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Bunionectomy Study (0000-063)

Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acute Pain

Intervention: pregabalin (Drug); naproxen sodium (Drug); Comparator: Placebo (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Merck Sharp & Dohme Corp.

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck Sharp & Dohme Corp.


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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Total Patient Controlled Analgesic (PCA) Hydromorphone Consumption Over the 24 Hours Post-surgery

Secondary outcome: Time to First Request of PCA Hydromorphone


Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.


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.)

Locations and Contacts

Additional Information

Starting date: July 2007
Last updated: March 23, 2015

Page last updated: August 23, 2015

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