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Completed

NCT Number: NCT00092378

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

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

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Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Bunion removal

Exclusion criteria

  • Any known allergies to the study design

Treatment and study plan

MK0966, rofecoxib

Drug

Comparator: diclofenac sodium, placebo

Drug

Primary outcomes

  1. Overall analgesic effect over 8 hours

Secondary outcomes

  1. Time to onset of analgesic effect.

  2. The use of supplemental analgesia on Days 2-3.

  3. Peak analgesic effect on Day 1.

  4. Overall safety and tolerability.

  5. The analgesic effect on Days 2-3.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2003
Study completion
2003
First posted
Sep 27, 2004
Registry last updated
May 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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