- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00092326
A Study of Two Approved Drugs in the Treatment of Postoperative Dental Pain (0966-183)
February 19, 2016 updated by: Merck Sharp & Dohme LLC
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
The purpose of this study is to compare the safety and effectiveness of two approved drugs in the treatment of pain following dental surgery.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The duration of treatment is 24 hours.
Study Type
Interventional
Enrollment (Actual)
269
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Impaction of a molar tooth requiring removal
Exclusion Criteria:
- Any known allergy to the study drugs
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
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
Outcome Measure |
---|
Time to onset of analgesic effect, peak analgesic effect, and/or duration of analgesic effect over 24 hours.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2002
Primary Completion (Actual)
September 1, 2002
Study Completion (Actual)
September 1, 2002
Study Registration Dates
First Submitted
September 22, 2004
First Submitted That Met QC Criteria
September 24, 2004
First Posted (Estimate)
September 27, 2004
Study Record Updates
Last Update Posted (Estimate)
February 22, 2016
Last Update Submitted That Met QC Criteria
February 19, 2016
Last Verified
February 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Postoperative Complications
- Pain
- Neurologic Manifestations
- Stomatognathic Diseases
- Tooth Diseases
- Facial Pain
- Pain, Postoperative
- Toothache
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Antipyretics
- Analgesics, Opioid
- Narcotics
- Cyclooxygenase 2 Inhibitors
- Acetaminophen
- Oxycodone
- Rofecoxib
Other Study ID Numbers
- 0966-183
- 2004_068
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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