A Study of Two Approved Drugs in the Treatment of Postope... | NCT00092313

Studies
A Study of Two Approved Drugs in the Treatment of Postoperative Dental Pain (0966-182)

NCT00092313

Sponsor

Merck Sharp & Dohme LLC

Status

Completed

Last Update Posted

Nov 25, 2015Estimated

Enrollment

271Actual

Phase

Phase 3

Conditions

Postoperative Pain

Interventions

MK0966, rofecoxib
Comparator: oxycodone and acetaminophen

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

Nov 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

Jun 2002

Primary Completion Date

Sep 2002Actual

Completion Date

Sep 2002Actual

First Submitted Date

Sep 22, 2004

First Submission Date that Met QC Criteria

Sep 24, 2004

First Posted Date

Sep 27, 2004Estimated

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

Nov 24, 2015

Last Update Posted Date

Nov 25, 2015Estimated

Description Module

Brief Summary

The purpose of this study is to compare the safety and effectiveness of two approved drugs in the treatment of pain following dental surgery.

Detailed Description

The duration of treatment is 24 hours.

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 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

271Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Post-op dental pain over 6 hours as measured by pain intensity/relief scores, patient global assessment, and time to perceptible/meaningful pain relief.

Secondary Outcomes

Measure	Description	Time Frame
Time to onset of analgesic effect, peak analgesic effect, and/or duration of analgesic effect over 24 hours.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Impaction of a molar tooth requiring removal

Exclusion Criteria:

Known allergy to the study drugs

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

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

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
15200753	Background	Chang DJ, Desjardins PJ, Bird SR, Black P, Chen E, Petruschke RA, Geba GP. Comparison of rofecoxib and a multidose oxycodone/ acetaminophen regimen for the treatment of acute pain following oral surgery: a randomized controlled trial. Curr Med Res Opin. 2004 Jun;20(6):939-49. doi: 10.1185/030079904125003863.

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

ID	Term
C116926	rofecoxib
D000082	Acetaminophen

ID	Term
D000083	Acetanilides
D000813	Anilides
D000577	Amides
D009930	Organic Chemicals
D000814

Name	Type	Description	Arm Group Labels	Other Names
MK0966, rofecoxib	Drug
Comparator: oxycodone and acetaminophen	Drug

ID	Type	Description	Link
MK0966-182
2004_067