A Study of Two Approved Drugs in the Treatment of Postoperative Dental Pain (0966-181)(COMPLETED)

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. Identifier: NCT00092300
Recruitment Status : Completed
First Posted : September 28, 2004
Last Update Posted : August 4, 2015
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
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 or disease Intervention/treatment Phase
Postoperative Pain Drug: MK0966, rofecoxib Drug: Comparator: valdecoxib Phase 3

Detailed Description:
The duration of treatment is 1 day.

Study Type : Interventional  (Clinical Trial)
Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Study Start Date : May 2002
Actual Primary Completion Date : September 2002

Resource links provided by the National Library of Medicine

Drug Information available for: Valdecoxib

Primary Outcome Measures :
  1. Overall analgesic effect over 12 hours.

Secondary Outcome Measures :
  1. Overall analgesic effect over 8 hours.
  2. Time to onset of analgesic, peak analgesic and duration of analgesic effects.
  3. Overall analgesic, time to onset of analgesic, peak analgesic, and duration analgesic effects
  4. Safety and tolerability.

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Impaction of a molar tooth requiring removal

Exclusion Criteria:

  • Known allergies to the study drug

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00092300

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Study Director: Medical Monitor Merck Sharp & Dohme Corp.

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00092300     History of Changes
Other Study ID Numbers: 0966-181
First Posted: September 28, 2004    Key Record Dates
Last Update Posted: August 4, 2015
Last Verified: July 2015

Keywords provided by Merck Sharp & Dohme Corp.:
dental surgery
molar removal

Additional relevant MeSH terms:
Pain, Postoperative
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Tooth Diseases
Stomatognathic Diseases
Facial Pain
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents