Bunionectomy Study (0000-063)
Condition: Acute Pain
MeSH terms: Acute Pain
Intervention: pregabalin; naproxen sodium; Comparator: Placebo
Intervention description: 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.; 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.; 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.
Intervention MeSH terms: Naproxen; Pregabalin
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Primary, unilateral, first metatarsal bunionectomy with osteotomy

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.
    

Eligibility criteria:

        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.)