A Study of Two Approved Drugs in the Treatment of Post-Bunionectomy Surgery Pain - Full Text View

Sponsor:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00092378

Purpose

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

Condition	Intervention	Phase
Postoperative Pain	Drug: MK0966, rofecoxib Drug: Comparator: diclofenac sodium, placebo	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
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

Resource links provided by NLM:

Drug Information available for: Diclofenac sodium Diclofenac potassium Diclofenac Rofecoxib

U.S. FDA Resources

Further study details as provided by Merck:

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.

Estimated Enrollment:	240
Study Start Date:	September 2003
Study Completion Date:	December 2003
Primary Completion Date:	December 2003 (Final data collection date for primary outcome measure)

Detailed Description:

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Bunion removal

Exclusion Criteria:

Any known allergies to the study design

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00092378

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Publications:

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.

Responsible Party:	Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT00092378 History of Changes
Other Study ID Numbers:	2004_072
Study First Received:	September 22, 2004
Last Updated:	January 21, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Merck:

Bunionectomy

Additional relevant MeSH terms:

Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Diclofenac
Rofecoxib
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents

Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents
Cyclooxygenase 2 Inhibitors

ClinicalTrials.gov processed this record on February 09, 2012