A Study To Evaluate An NK-1 Antiemetic For The Prevention Of Post Operative Nausea And Vomiting

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

GlaxoSmithKline

ClinicalTrials.gov Identifier:

NCT00108095

First received: April 13, 2005

Last updated: November 21, 2012

Last verified: November 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

April 13, 2005

Last Updated Date

November 21, 2012

Start Date ^ICMJE

October 2004

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Number of subjects who achieve a complete response (defined as no vomiting, no retching, no rescue therapy, and no premature discontinuation from the study) during the first 24 hour evaluation period following emergence from anesthesia

Original Primary Outcome Measures ^ICMJE

To assess the number of subjects who achieve a complete response (defined as no vomiting, no retching, no rescue therapy, and no premature discontinutation from the study) during the first 24 hour evaluation period following emergence from anesthesia.

Change History

Complete list of historical versions of study NCT00108095 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Number of subjects who achieve a complete response during each subsequent 24 hour evaluation period (up to 120 hours)following the emergence from anesthesia
The extent of nausea experienced by subjects.

Original Secondary Outcome Measures ^ICMJE

1)To assess the number of subjects who achieve a complete response during each subsequent 24 hour evaluation period (up to 120 hours) following the emergence from anesthesia.
2)The extent of nausea experienced by subjects during the 2,6, and 24 evaluation periods, by Likert scale.
3)The extent of nausea experienced by subjects daily at each subsequent 24 hour evaluation period (up to 120 hours) by Likert scale.
4)Safety assessments, incl routine physical exam, vital signs, ECG, labs, AE reporting.
5)Quality of life assessment.
6)Subject satisfaction with treatment.
7)Assessment of post op pain.
8)PK and PD parameters.

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

A Study To Evaluate An NK-1 Antiemetic For The Prevention Of Post Operative Nausea And Vomiting

Official Title ^ICMJE

See Detailed Description

Brief Summary

This study is looking at a range of doses of this NK-1 receptor antagonist drug, for both safety and effectiveness in prevention PONV

Detailed Description

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Parallel Group Phase II Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of the Oral Neurokinin-1 Receptor Antagonist, GW67969, When Administered With Intravenous Ondansetron Hydrochloride for the Prevention of Post-Operative Nausea and Vomiting (PONV) and Post-Discharge Nausea and Vomiting (PDNV) in Female Subjects With Known Risk Factors for PONV Who Are Undergoing Surgical Procedures Associated With an Increased Emetogenic Risk

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Condition ^ICMJE

Postoperative Nausea and Vomiting
Nausea and Vomiting, Postoperative

Intervention ^ICMJE

Drug: intravenous ondansetron

Other Name: intravenous ondansetron

Study Arm (s)

Not Provided

Publications *

Singla NK, Singla SK, Chung F, Kutsogiannis DJ, Blackburn L, Lane SR, Levin J, Johnson B, Pergolizzi JV Jr. Phase II study to evaluate the safety and efficacy of the oral neurokinin-1 receptor antagonist casopitant (GW679769) administered with ondansetron for the prevention of postoperative and postdischarge nausea and vomiting in high-risk patients. Anesthesiology. 2010 Jul;113(1):74-82.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

665

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion criteria:

Females age 18-55
Laparoscopic/laparotomic gynecological procedure of laparoscopic gallbladder removal

Exclusion criteria:

Pregnant or breastfeeding
Post-menopausal
Not undergoing general anesthesia

Gender

Female

Ages

18 Years to 55 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Belgium, Canada, Germany, Hungary, Spain

Administrative Information

NCT Number ^ICMJE

NCT00108095

Other Study ID Numbers ^ICMJE

NKT102260

Has Data Monitoring Committee

Not Provided

Responsible Party

GlaxoSmithKline

Study Sponsor ^ICMJE

GlaxoSmithKline

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

GSK Clinical Trials

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

November 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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