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

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00092300
First received: September 22, 2004
Last updated: May 20, 2013
Last verified: May 2013
History of Changes
  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 3

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, Single Dose Study of the Effect of Rofecoxib 50 mg and Valdecoxib 20 mg in Patients With Postoperative Dental Pain

Resource links provided by NLM:

Drug Information available for: Valdecoxib
U.S. FDA Resources

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
Primary Completion Date: September 2002 (Final data collection date for primary outcome measure)
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00092300

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

Publications:

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00092300     History of Changes
Other Study ID Numbers: 2004_066, MK0966-181
Study First Received: September 22, 2004
Last Updated: May 20, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck:
dental surgery
molar removal

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

ClinicalTrials.gov processed this record on May 23, 2013