We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00092378
First Posted: September 27, 2004
Last Update Posted: May 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
September 22, 2004
September 27, 2004
May 9, 2017
September 1, 2003
December 1, 2003   (Final data collection date for primary outcome measure)
Overall analgesic effect over 8 hours
Not Provided
Complete list of historical versions of study NCT00092378 on ClinicalTrials.gov Archive Site
  • 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.
Not Provided
Not Provided
Not Provided
 
A Study of Two Approved Drugs in the Treatment of Post-Bunionectomy Surgery Pain (0966-234)(COMPLETED)
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
This purpose of this study is to compare the safety and effectiveness of two approved drugs in the treatment of pain following bunionectomy surgery.
The duration of treatment is 5 days for rofecoxib and 1 day for diclofenac sodium.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Postoperative Pain
  • Drug: MK0966, rofecoxib
  • Drug: Comparator: diclofenac sodium, placebo
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
251
December 1, 2003
December 1, 2003   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Bunion removal

Exclusion Criteria:

  • Any known allergies to the study design
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00092378
0966-234
2004_072
Not Provided
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP