A Study to Evaluate the Efficacy of MK0719 in the Prevent... | NCT00424424

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

NCT00424424

Sponsor

Merck Sharp & Dohme LLC

Status

Terminated

Last Update Posted

Nov 2, 2015Estimated

Enrollment

81Actual

Phase

Phase 2

Conditions

Pain, Postoperative

Interventions

MK0719

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2007_505

Status Module

Record Verification Date

Oct 2015

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Aug 2006

Primary Completion Date

Jan 2007Actual

Completion Date

Jan 2007Actual

First Submitted Date

Jan 18, 2007

First Submission Date that Met QC Criteria

Jan 18, 2007

First Posted Date

Jan 19, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 30, 2015

Last Update Posted Date

Nov 2, 2015Estimated

Description Module

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).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

81Actual

Name	Type	Description	Arm Group Labels	Other Names
MK0719	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Proprietary Information - Exploratory (Non-Confirmatory) Trial

Secondary Outcomes

Measure	Description	Time Frame
Proprietary Information - Exploratory (Non-Confirmatory) Trial

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Medical Monitor	Merck Sharp & Dohme LLC	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D010149	Pain, Postoperative

Ancestor Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010146	Pain

Browse Leaves

Not provided

Browse Branches

Not provided