Dental Pain (Following Third Molar Tooth Extraction) Study | NCT00114049

Studies
Dental Pain (Following Third Molar Tooth Extraction) Study

NCT00114049

Sponsor

GlaxoSmithKline

Status

Completed

Last Update Posted

Jan 19, 2017Estimated

Enrollment

300

Phase

Phase 3

Conditions

Dental Pain
Surgery, Dental

Interventions

GW406381

Countries

United States

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

Official Title

A Pivotal Phase III, Single Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Dose-Ranging Study to Investigate the Efficacy and Safety of Single Oral Doses of 10mg, 25mg, 50mg and 70mg GW406381 and 550mg Naproxen Sodium in Subjects With Pain Following Third Molar Tooth Extraction

Status Module

Record Verification Date

Jan 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Dec 2004

Primary Completion Date

Apr 2005Actual

Completion Date

Apr 2005Actual

First Submitted Date

Jun 13, 2005

First Submission Date that Met QC Criteria

Jun 13, 2005

First Posted Date

Jun 14, 2005Estimated

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

Jan 18, 2017

Last Update Posted Date

Jan 19, 2017Estimated

Description Module

Brief Summary

The purpose of this study is to evaluate the effectiveness of GW406381 (a COX-2 inhibitor) in treating the signs and symptoms of dental pain following third molar tooth extraction.

Detailed Description

A Pivotal Phase III, Single Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Dose-Ranging Study to Investigate the Efficacy and Safety of Single Oral Doses of 10mg, 25mg, 50mg, and 70mg GW406381 and 550mg Naproxen Sodium in Subjects With Pain Following Third Molar Tooth Extraction

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

300

Name	Type	Description	Arm Group Labels	Other Names
GW406381	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Difference between treatments over time based on pain intensity and pain relief scores.

Secondary Outcomes

Measure	Description	Time Frame
Difference between treatments based on changes in onset, duration of activity, overall effectiveness, and patient based assessments.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Scheduled for outpatient surgical removal of at least two third molar teeth.

Exclusion criteria:

Subjects who do not achieve moderate to severe pain.
Subjects who do not use acceptable contraception.
Additional medical criteria will be assessed by the investigator.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
GSK Clinical Trials, MD	GlaxoSmithKline	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Austin	Texas	78703	United States

Condition Browse Module

MeSH Terms

ID	Term
D014098	Toothache

Ancestor Terms

ID	Term
D014076	Tooth Diseases
D009057	Stomatognathic Diseases
D005157	Facial Pain
D010146	Pain

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C469818	GW406381X

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided