Study Of An NK-1 Anti-Emetic Medication For The Preventio... | NCT00600990

Studies
Study Of An NK-1 Anti-Emetic Medication For The Prevention Of Post-Operative Nausea And Vomiting In Female Patients

NCT00600990

Sponsor

GlaxoSmithKline

Status

Completed

Last Update Posted

Jan 20, 2017Estimated

Enrollment

624Actual

Phase

Phase 2

Conditions

Postoperative Nausea and Vomiting
Nausea and Vomiting, Postoperative

Interventions

GW597599

Countries

United States
Australia
Belgium
Canada
Chile
Czechia
Finland
Netherlands
Poland
South Africa
Turkey (Türkiye)
United Kingdom

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

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

Jul 2006Actual

Completion Date

Jul 2006Actual

First Submitted Date

Jan 15, 2008

First Submission Date that Met QC Criteria

Jan 15, 2008

First Posted Date

Jan 25, 2008Estimated

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 19, 2017

Last Update Posted Date

Jan 20, 2017Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to determine the effectiveness of this medication in preventing nausea and vomiting in female patients at risk for post-operative nausea and vomiting (PONV).

Detailed Description

A Multicenter, Randomized, Double-blind, Double-dummy, Placebo-controlled, Parallel Group, Phase II Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Oral (25 mg) and Intravenous (3 mg and 18 mg) Formulations of the Neurokinin-1 Receptor Antagonist, GW597599, When Administered with Intravenous Ondansetron Hydrochloride for the Prevention of Post-operative Nausea and Vomiting and Post-discharge Nausea and Vomiting in Female Subjects with Known Risk Factors for PONV Who are Undergoing Surgical Procedures Associated with an Increased Emetogenic Risk

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

624Actual

Name	Type	Description	Arm Group Labels	Other Names
GW597599	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The number of subjects who achieve a complete antiemetic response during the first 24 hour evaluation period following the emergence from anesthesia.

Secondary Outcomes

Measure	Description	Time Frame
The number of subjects who achieve a complete antiemetic response during each subsequent 24 hour evaluation period (up to 120 hours) following the emergence from anesthesia.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

known risk factors for PONV.
Undergoing gynecological or gallbladder surgery.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Little Rock	Arkansas	72205	United States
GSK Investigational Site

Type	Date	Date Unknown
Release	Jul 25, 2017
Reset	Feb 15, 2018
Release	Mar 7, 2018

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Jul 25, 2017			Feb 15, 2018
Mar 7, 2018	Aug 15, 2018

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D009325	Nausea
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms