Back to resultsA Study of Two Approved Drugs in the Treatment of Post-Bunionectomy Surgery Pain (0966-234)(COMPLETED)
Primary Purpose
Postoperative Pain
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
MK0966, rofecoxib
Comparator: diclofenac sodium, placebo
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain focused on measuring Bunionectomy
Eligibility Criteria
Inclusion Criteria: Bunion removal Exclusion Criteria: Any known allergies to the study design
Sites / Locations
Outcomes
Primary Outcome Measures
Overall analgesic effect over 8 hours
Secondary Outcome 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.
Full Information
NCT ID
NCT00092378
First Posted
September 22, 2004
Last Updated
May 5, 2017
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT00092378
Brief Title
A Study of Two Approved Drugs in the Treatment of Post-Bunionectomy Surgery Pain (0966-234)(COMPLETED)
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
September 1, 2003 (Actual)
Primary Completion Date
December 1, 2003 (Actual)
Study Completion Date
December 1, 2003 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
5. Study Description
Brief Summary
This purpose of this study is to compare the safety and effectiveness of two approved drugs in the treatment of pain following bunionectomy surgery.
Detailed Description
The duration of treatment is 5 days for rofecoxib and 1 day for diclofenac sodium.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
Bunionectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
251 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
MK0966, rofecoxib
Intervention Type
Drug
Intervention Name(s)
Comparator: diclofenac sodium, placebo
Primary Outcome Measure Information:
Title
Overall analgesic effect over 8 hours
Secondary Outcome Measure Information:
Title
Time to onset of analgesic effect.
Title
The use of supplemental analgesia on Days 2-3.
Title
Peak analgesic effect on Day 1.
Title
Overall safety and tolerability.
Title
The analgesic effect on Days 2-3.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Bunion removal
Exclusion Criteria:
Any known allergies to the study design
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
15462686
Citation
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.
Results Reference
background
Available IPD and Supporting Information:
Available IPD/Information Type
CSR Synopsis
Available IPD/Information URL
http://www.merck.com/clinical-trials/policies-perspectives.html
Learn more about this trial
A Study of Two Approved Drugs in the Treatment of Post-Bunionectomy Surgery Pain (0966-234)(COMPLETED)
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