NCT00387140

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 treatment of postoperative dental pain in male patients.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
89

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2006

Shorter than P25 for phase_2

Status
completed

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

October 1, 2006

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

October 9, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 12, 2006

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
Last Updated

November 2, 2015

Status Verified

October 1, 2015

Enrollment Period

7 months

First QC Date

October 9, 2006

Last Update Submit

October 30, 2015

Conditions

Pain, PostoperativeTooth Extraction

Keywords

Dental Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

  • Peak analgesic response, safety, and tolerability

    Over 24 Hours

Secondary Outcomes (1)

  • Onset of analgesia, duration of analgesia

    Over 24 Hours

Interventions

MK2295DRUG

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • Patient has a temperature of 37.5C or greater prior to dosing
  • Patient has participated in another clinical study within the last 4 weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pain, PostoperativeToothache

Interventions

MK-2295

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsTooth DiseasesStomatognathic DiseasesFacial Pain

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 9, 2006

First Posted

October 12, 2006

Study Start

October 1, 2006

Primary Completion

May 1, 2007

Study Completion

May 1, 2007

Last Updated

November 2, 2015

Record last verified: 2015-10