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A Study of Two Approved Drugs in the Treatment of Postoperative Dental Pain (0966-183)

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ClinicalTrials.gov Identifier: NCT00092326
Recruitment Status : Completed
First Posted : September 27, 2004
Last Update Posted : February 22, 2016
Sponsor:
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: oxycodone with acetaminophen, placebo Phase 3

Detailed Description:
The duration of treatment is 24 hours.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 269 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 Study to Evaluate the Efficacy of Rofecoxib and a Dosing Regimen of Oxycodone With Acetaminophen Over 24 Hours in Patients With Postoperative Dental Pain
Study Start Date : June 2002
Actual Primary Completion Date : September 2002
Actual Study Completion Date : September 2002

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Post-op dental pain over 6 hours as measured by pain intensity/relief scores, patient global assessment, and time to perceptible/meaningful pain relief.

Secondary Outcome Measures :
  1. Time to onset of analgesic effect, peak analgesic effect, and/or duration of analgesic effect over 24 hours.


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
Criteria

Inclusion Criteria:

  • Impaction of a molar tooth requiring removal

Exclusion Criteria:

  • Any known allergy to the study drugs

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 ClinicalTrials.gov identifier (NCT number): NCT00092326


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

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00092326     History of Changes
Other Study ID Numbers: 0966-183
2004_068
First Posted: September 27, 2004    Key Record Dates
Last Update Posted: February 22, 2016
Last Verified: February 2016

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

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