Bunionectomy Study (0000-063)

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 Overview

• Status: Completed
• Conditions: Acute Pain
• Intervention / Treatment: Drug: pregabalin; Drug: naproxen sodium; Drug: Comparator: Placebo

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Arm 1: Pregabalin 300 mg	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.
ACTIVE_COMPARATOR: Arm 2: naproxen sodium 550 mg	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.; Other Names: naproxen
PLACEBO_COMPARATOR: Arm 3: Placebo	Drug: Comparator: Placebo; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Patient Controlled Analgesic (PCA) Hydromorphone Consumption Over the 24 Hours Post-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.	First 24 hours following surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to First Request of PCA Hydromorphone	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.	First 24 hours following surgery

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Publications and helpful links

General Publications

• Wang H, Gargano C, Lukac S, Jackson A, Beals C, Smiley P, Drexel M, Ruddy M, Herman G, Johnson-Levonas AO, Medve R, Webster L, Reicin A. An enhanced bunionectomy model as a potential tool for early decision-making in the development of new analgesics. Adv Ther. 2010 Dec;27(12):963-80. doi: 10.1007/s12325-010-0084-8. Epub 2010 Nov 3.

Study record dates

Study Major Dates

• Study Start: July 1, 2007
• Primary Completion (ACTUAL): January 1, 2008
• Study Completion (ACTUAL): January 1, 2008

Study Registration Dates

• First Submitted: January 15, 2008
• First Submitted That Met QC Criteria: January 25, 2008
• First Posted (ESTIMATE): January 28, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): April 10, 2015
• Last Update Submitted That Met QC Criteria: March 23, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: Primary, unilateral, first metatarsal bunionectomy with osteotomy
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Acute Pain; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Tranquilizing Agents; Psychotropic Drugs; Membrane Transport Modulators; Anti-Anxiety Agents; Anticonvulsants; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Gout Suppressants; Pregabalin; Naproxen
• Other Study ID Numbers: 0000-063; 063; 2007_661