Bunionectomy Study (0000-063)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Acute Pain

Treatments: Drug: naproxen sodium; Drug: pregabalin; Drug: Comparator: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00601458

0000-063

063

2007_661

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 3 patient groups, including a placebo group

Arm 1: Pregabalin 300 mg

Active Comparator group

Treatment:

Drug: pregabalin

Arm 2: naproxen sodium 550 mg

Active Comparator group

Treatment:

Drug: naproxen sodium

Arm 3: Placebo

Placebo Comparator group

Treatment:

Drug: Comparator: Placebo