A Study of Two Approved Drugs in the Treatment of Post-Bunionectomy Surgery Pain (0966-234)(COMPLETED)

Overview

This purpose of this study is to compare the safety and effectiveness of two approved drugs in the treatment of pain following bunionectomy surgery.

Full Title of Study: “A Randomized, Double-Blind, Placebo- and Active-Comparator-Controlled, Parallel-Group Study of Rofecoxib and Diclofenac Sodium in the Treatment of Post-Bunionectomy Surgery Pain”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: December 1, 2003

Detailed Description

The duration of treatment is 5 days for rofecoxib and 1 day for diclofenac sodium.

Interventions

  • Drug: MK0966, rofecoxib
  • Drug: Comparator: diclofenac sodium, placebo

Clinical Trial Outcome Measures

Primary Measures

  • Overall analgesic effect over 8 hours

Secondary Measures

  • Time to onset of analgesic effect.
  • The use of supplemental analgesia on Days 2-3.
  • Peak analgesic effect on Day 1.
  • Overall safety and tolerability.
  • The analgesic effect on Days 2-3.

Participating in This Clinical Trial

Inclusion Criteria

  • Bunion removal Exclusion Criteria:

  • Any known allergies to the study design

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Merck Sharp & Dohme LLC
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Medical Monitor, Study Director, Merck Sharp & Dohme LLC

References

Desjardins PJ, Black PM, Daniels S, Bird SR, Fitzgerald BJ, Petruschke RA, Tershakovec A, Chang DJ. A randomized controlled study comparing rofecoxib, diclofenac sodium, and placebo in post-bunionectomy pain. Curr Med Res Opin. 2004 Oct;20(10):1523-37. doi: 10.1185/030079904X3069.

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