NCT00424424

Brief 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).

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Aug 2006

Shorter than P25 for phase_2

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

January 18, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 19, 2007

Completed
Last Updated

November 2, 2015

Status Verified

October 1, 2015

Enrollment Period

5 months

First QC Date

January 18, 2007

Last Update Submit

October 30, 2015

Conditions

Pain, Postoperative

Keywords

Postoperative Dental Pain

Outcome Measures

Primary Outcomes (1)

  • Proprietary Information - Exploratory (Non-Confirmatory) Trial

Secondary Outcomes (1)

  • Proprietary Information - Exploratory (Non-Confirmatory) Trial

Interventions

MK0719DRUG

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2007

First Posted

January 19, 2007

Study Start

August 1, 2006

Primary Completion

January 1, 2007

Study Completion

January 1, 2007

Last Updated

November 2, 2015

Record last verified: 2015-10