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A Study of Two Approved Drugs in the Treatment of Postoperative Dental Pain (0966-182)

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: NCT00092313
Recruitment Status : Completed
First Posted : September 27, 2004
Last Update Posted : November 25, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme LLC

Tracking Information
First Submitted Date  ICMJE September 22, 2004
First Posted Date  ICMJE September 27, 2004
Last Update Posted Date November 25, 2015
Study Start Date  ICMJE June 2002
Actual Primary Completion Date September 2002   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 28, 2006)
Post-op dental pain over 6 hours as measured by pain intensity/relief scores, patient global assessment, and time to perceptible/meaningful pain relief.
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 28, 2006)
Time to onset of analgesic effect, peak analgesic effect, and/or duration of analgesic effect over 24 hours.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Two Approved Drugs in the Treatment of Postoperative Dental Pain (0966-182)
Official Title  ICMJE 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
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.
Detailed Description The duration of treatment is 24 hours.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Postoperative Pain
Intervention  ICMJE
  • Drug: MK0966, rofecoxib
  • Drug: Comparator: oxycodone and acetaminophen
Study Arms  ICMJE Not Provided
Publications * Chang DJ, Desjardins PJ, Bird SR, Black P, Chen E, Petruschke RA, Geba GP. Comparison of rofecoxib and a multidose oxycodone/ acetaminophen regimen for the treatment of acute pain following oral surgery: a randomized controlled trial. Curr Med Res Opin. 2004 Jun;20(6):939-49.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 21, 2014)
271
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE September 2002
Actual Primary Completion Date September 2002   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Impaction of a molar tooth requiring removal

Exclusion Criteria:

  • Known allergy to the study drugs
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00092313
Other Study ID Numbers  ICMJE 0966-182
MK0966-182
2004_067
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Merck Sharp & Dohme LLC
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE Merck Sharp & Dohme LLC
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Monitor Merck Sharp & Dohme LLC
PRS Account Merck Sharp & Dohme LLC
Verification Date November 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP