See Detailed Description

CompletadoFase 2ClinicalTrials.gov

ID: NCT00169572Tipo: INTERVENTIONALInicio: 1 de feb de 2005

Traducción no disponible, mostrando original

Resumen

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.

Descripción detallada

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.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Willing to provide a written informed consent prior to receiving any study-specific procedures or assessments.
Diagnosed with a solid malignant tumour and has not previously received chemotherapy.
Scheduled to receive chemotherapy conducive to regimens outlined in the study protocol.

Criterios de exclusión

Not received any investigational product within 30 days of enrolment into the study.
Must not be pregnant.
Must not be of childbearing potential or is willing to use specific barrier methods outlined in the protocol.
Must not be scheduled to receive radiation therapy to the abdomen or to the pelvis within seven (7) days prior to starting study medication.
Must not be currently under treatment for a condition which may cause nausea or vomiting (i.e., active peptic ulcer disease, gastric obstruction).
Must not have a history of peptic ulcer disease.

Intervenciones

drug

Aprepitant

drug

Ondansetron

drug

GW679769

drug

Dexamethasone

Ubicaciones

GSK Investigational Site

Capital Federal, Buenos Aires, Argentina

GSK Investigational Site

Buenos Aires, Argentina

Patrocinadores

PrincipalGlaxoSmithKline

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See Detailed Description | EligiMed