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A Study of Two Approved Drugs in the Treatment of Postoperative Dental Pain

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00092339
First received: September 22, 2004
Last updated: January 21, 2010
Last verified: January 2010
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, placebo
 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-Controlled, Single-Dose Study to Evaluate the Effects of Rofecoxib 50 mg and Valdecoxib 40 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 as measured by total pain relief over 12 hours.

Secondary Outcome Measures:
  • Overall analgesic effect over 8 hrs.
  • Time to onset of analgesic, peak analgesic and duration of analgesic effects.
  • Percent of patients using and amount used of supplemental analgesia within 8, 12, and 24 hrs.
  • Overall safety and tolerability.

Estimated Enrollment: 125
Study Start Date: August 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:

  • Any known allergy to the study drugs
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00092339

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: NCT00092339     History of Changes
Other Study ID Numbers: 2004_069
Study First Received: September 22, 2004
Last Updated: January 21, 2010
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 16, 2013