A Study to Evaluate the Safety and Efficacy of an Investigational Drug in the Treatment of Postoperative Dental Pain (MK-2295-005)

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.

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Key information

Conditions

Pain, Postoperative Facial Pain Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Stomatognathic Diseases Tooth Diseases Tooth Extraction Toothache

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

MK2295

Drug

Primary outcomes

Peak analgesic response, safety, and tolerability

Time frame: Over 24 Hours

Secondary outcomes

Onset of analgesia, duration of analgesia

Time frame: Over 24 Hours

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Randomized Double-blind, Placebo-and Active Comparator-Controlled 2-Part Study to Evaluate the Efficacy of MK2295 in Patients With Postoperative Dental Pain

Important dates

Study start: 2006
Primary completion: 2007
Study completion: 2007
First posted: Oct 12, 2006
Registry last updated: Nov 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed