A Study to Evaluate the Safety and Efficacy of an Investi... | NCT00387140

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

NCT00387140

Sponsor

Merck Sharp & Dohme LLC

Status

Completed

Last Update Posted

Nov 2, 2015Estimated

Enrollment

89Actual

Phase

Phase 2

Conditions

Pain, Postoperative
Tooth Extraction

Interventions

MK2295

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

Status Module

Record Verification Date

Oct 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2006

Primary Completion Date

May 2007Actual

Completion Date

May 2007Actual

First Submitted Date

Oct 9, 2006

First Submission Date that Met QC Criteria

Oct 9, 2006

First Posted Date

Oct 12, 2006Estimated

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 treatment of postoperative dental pain in male patients.

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

89Actual

Name	Type	Description	Arm Group Labels	Other Names
MK2295	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Peak analgesic response, safety, and tolerability		Over 24 Hours

Secondary Outcomes

Measure	Description	Time Frame
Onset of analgesia, duration of analgesia		Over 24 Hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

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
D014098	Toothache

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

Intervention Browse Module

MeSH Terms

ID	Term
C574563	MK-2295

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

ID	Type	Description	Link
MK2295-005
2006_518