Post-Operative Nausea And Vomiting Study In Female Patients

Phase 2

Completed

• Conditions: Nausea and Vomiting, Postoperative; Postoperative Nausea and Vomiting

• Registration Number: NCT00274690
• Lead Sponsor: GlaxoSmithKline

Brief Summary

The primary purpose of this study is to determine an effective dose of this NK-1 anti-emetic medication to prevent nausea and vomiting in females after surgery.

Detailed Description

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase II Study to Evaluate the Safety and Efficacy of Oral Dosing with GW679769 (50 mg or 150 mg) for Three Consecutive Days When Administered with a Single Intravenous Dose of 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 Post-operative Nausea and Vomiting Who are Undergoing Laparoscopic/Laparotomic Surgical Procedures Associated with an Increased Emetogenic Risk

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2005-02
• Primary Completion: 2005-08
• Study Completion: 2005-08
• Study First Submitted: 2006-01-09
• Study First Submitted QC: 2006-01-09
• Study First Posted: 2006-01-11
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-19
• Last Update Posted: 2017-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 435

Inclusion Criteria

• Known, specified risk factors for PONV (post operative nausea and vomiting)
• Undergoing gynecologic or gallbladder surgery.

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Exclusion Criteria

• pregnant or breastfeeding
• post-menopausal

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The proportion of subjects who achieve a complete response (defined as no vomiting, no retching, no rescue therapy, & no premature discontinuation from the study) during the first 72 hr evaluation period following the emergence from anesthesia.	72 Hours

Secondary Outcome Measures

Name	Time	Method
The proportion of subjects who achieve a complete response during each subsequent 24-hr eval period (up to 120 hrs) following the emergence from anesthesia.	120 Hours

Trial Locations

Locations (1)

GSK Investigational Site; 🇬🇧 Hull, United Kingdom