A Study of Two Approved Drugs in the Treatment of Postoperative Dental Pain - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00092300

Purpose

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

Condition	Intervention	Phase
Postoperative Pain	Drug: MK0966, rofecoxib Drug: Comparator: valdecoxib	Phase III

Drug Information available for: Rofecoxib Valdecoxib

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Double-Blind, Placebo- and Active-Comparator-Controlled, Single Dose Study of the Effect of Rofecoxib 50 mg and Valdecoxib 20 mg in Patients With Postoperative Dental Pain

Further study details as provided by Merck:

Primary Outcome Measures:

Overall analgesic effect over 12 hours.

Secondary Outcome Measures:

Overall analgesic effect over 8 hours.
Time to onset of analgesic, peak analgesic and duration of analgesic effects.
Overall analgesic, time to onset of analgesic, peak analgesic, and duration analgesic effects
Safety and tolerability.

Estimated Enrollment:	450
Study Start Date:	May 2002

Detailed Description:

The duration of treatment is 1 day.

Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Impaction of a molar tooth requiring removal

Exclusion Criteria:

Known allergies to the study drug

Contacts and Locations

No Contacts or Locations Provided

More Information

Publications:

Daniels SE, Desjardins PJ, Bird SR, Smugar SS, Tershakovec AM. Rofecoxib 50 mg and valdecoxib 20 or 40 mg in adults and adolescents with postoperative pain after third molar extraction: results of two randomized, double-blind, placebo-controlled, single-dose studies. Clin Ther. 2006 Jul;28(7):1022-34.

Study ID Numbers:	2004_066
Study First Received:	September 22, 2004
Last Updated:	November 21, 2006
ClinicalTrials.gov Identifier:	NCT00092300
Health Authority:	United States: Food and Drug Administration

Keywords provided by Merck:

dental surgery
molar removal

Study placed in the following topic categories:

Signs and Symptoms
Postoperative Complications
Toothache
Rofecoxib

Pain
Valdecoxib
Pain, Postoperative

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase Inhibitors
Physiological Effects of Drugs
Enzyme Inhibitors
Cyclooxygenase 2 Inhibitors
Pharmacologic Actions
Pathologic Processes

Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 14, 2009