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History of Changes for Study: NCT00092313
A Study of Two Approved Drugs in the Treatment of Postoperative Dental Pain
Latest version (submitted November 24, 2015) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 June 23, 2005 None (earliest Version on record)
2 September 21, 2005 Study Status and Arms and Interventions
3 October 7, 2005 Recruitment Status and Study Status
4 February 28, 2006 Study Design, Outcome Measures, Arms and Interventions, Study Status and Study Identification
5 March 3, 2006 Arms and Interventions, Study Description and Study Status
6 May 17, 2006 Study Status
7 January 21, 2010 Study Status, Contacts/Locations, Study Design, Sponsor/Collaborators and Study Identification
8 October 30, 2013 Sponsor/Collaborators, Study Identification and Study Status
9 October 21, 2014 Study Design, Study Status and Study Identification
10 November 3, 2014 Study Status
11 November 24, 2015 Study Status
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Study NCT00092313
Submitted Date:  June 23, 2005 (v1)

Open or close this module Study Identification
Unique Protocol ID: 2004_067
Brief Title: A Study of Two Approved Drugs in the Treatment of Postoperative Dental Pain
Official Title:
Secondary IDs:
Open or close this module Study Status
Record Verification: November 2004
Overall Status: Active, not recruiting
Study Start:
Primary Completion:
Study Completion:
First Submitted: September 22, 2004
First Submitted that
Met QC Criteria:
September 24, 2004
First Posted: September 27, 2004 [Estimate]
Last Update Submitted that
Met QC Criteria:
June 23, 2005
Last Update Posted: June 24, 2005 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Merck Sharp & Dohme LLC
Responsible Party:
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:
Open or close this module 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.
Detailed Description:
Open or close this module Conditions
Conditions: Postoperative Pain
Keywords: dental surgery
molar removal
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2/Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms:
Masking: Double (masked roles unspecified)
Allocation: Randomized
Enrollment:
Open or close this module Arms and Interventions
Intervention Details:
Drug: Investigational Drug
Open or close this module Outcome Measures
Open or close this module Eligibility
Minimum Age: 16 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • Impaction of a molar tooth requiring removal

Exclusion Criteria:

  • Known allergy to the study drugs
Open or close this module Contacts/Locations
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations: 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. PubMed 15200753
Links:
Available IPD/Information:

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