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Clinical Trials/NCT00169572
NCT00169572
Completed
Phase 2

See Detailed Description

GlaxoSmithKline1 site in 1 country492 target enrollmentFebruary 2005
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ConditionsNausea and VomitingChemotherapy-Induced
DrugsAprepitantOndansetronGW679769Dexamethasone

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Nausea and Vomiting
Sponsor
GlaxoSmithKline
Enrollment
492
Locations
1
Primary Endpoint
The number of subjects who do not experience vomiting, retching or nausea over a 5 day period following the initiation of chemotherapy.
Status
Completed
Last Updated
15 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

This study was designed to assess the safety and efficacy of an investigational agent administered in addition to a standard anti-emetic regimen for the treatment of chemotherapy induced nausea and vomiting.

Detailed Description

Phase II Multicentre, Randomised, Double-Blind, Placebo and Active-Controlled, Dose-Ranging, Parallel Group Study of the Safety and Efficacy of The Oral Neurokinin-1 Receptor Antagonist, GW679769 in Combination with Ondansetron Hydrochloride and Dexamethasone for the Prevention of Chemotherapy-Induced Nausea and Vomiting in Cancer Subjects Receiving Highly Emetogenic Cisplatin-based Chemotherapy.

Registry
clinicaltrials.gov
Start Date
February 2005
End Date
TBD
Last Updated
15 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

The number of subjects who do not experience vomiting, retching or nausea over a 5 day period following the initiation of chemotherapy.

Secondary Outcomes

  • Routine physical exam findings, vital signs, routine clinical laboratory tests, clinical monitoring and/or observation, and adverse events reporting.

Study Sites (1)

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