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A Study of Two Approved Drugs in the Treatment of Postoperative Dental Pain (0966-190)(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.
ClinicalTrials.gov Identifier: NCT00092339
Recruitment Status : Completed
First Posted : September 27, 2004
Last Update Posted : May 9, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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, placebo Phase 3

Detailed Description:
The duration of treatment is 1 day.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 125 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Actual Study Start Date : August 1, 2002
Primary Completion Date : September 15, 2002
Study Completion Date : September 15, 2002

Resource links provided by the National Library of Medicine

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

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Overall analgesic effect as measured by total pain relief over 12 hours.

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
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
Contacts and Locations

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): NCT00092339


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

Publications:
Study Data/Documents: CSR Synopsis  This link exits the ClinicalTrials.gov site

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00092339     History of Changes
Other Study ID Numbers: 0966-190
2004_069
First Posted: September 27, 2004    Key Record Dates
Last Update Posted: May 9, 2017
Last Verified: May 2017

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
Valdecoxib
Rofecoxib
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents