A Study to Evaluate the Efficacy of MK0719 in the Prevention of Postoperative Dental Pain (0719-002)

Pain, Postoperative Clinical Trial

Official title:

Proprietary Information - Exploratory (Non-Confirmatory) Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00424424
• Other study ID #: 0719-002
• Secondary ID: 2007_505
• Status: Terminated
• Phase: Phase 2
• First received: January 18, 2007
• Last updated: October 30, 2015
• Start date: August 2006
• Est. completion date: January 2007

Study information

• Verified date: October 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study is being conducted to evaluate the safety and tolerability of the drug and to evaluate its efficacy compared to placebo and to ibuprofen in the prevention of postoperative dental pain in male patients.

This is an early phase trial and some specific protocol information is proprietary and not publicly available at this time. (Full information is available to trial participants).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 81
• Est. completion date: January 2007
• Est. primary completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria :

• Patients in generally good health who are scheduled to have 2 or more third molars removed, at least 1 of which is partially or completely embedded in bone and is a mandibular impaction

Exclusion Criteria :

• Patient has a history of any illness or condition that, in the opinion of the investigator, might confound the results of the study or pose additional risk to the patient

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Drug:
• MK0719

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proprietary Information - Exploratory (Non-Confirmatory) Trial
Secondary	Proprietary Information - Exploratory (Non-Confirmatory) Trial