Study for The Prevention Of Nausea in Cancer Patients Receiving Highly Emetogenic Cisplatin Based Chemotherapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00169572
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : May 10, 2010
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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.

Condition or disease Intervention/treatment Phase
Nausea and Vomiting Chemotherapy-Induced Drug: Aprepitant Drug: Ondansetron Drug: GW679769 Drug: Dexamethasone Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 492 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: See Detailed Description
Study Start Date : February 2005

Resource links provided by the National Library of Medicine

Intervention Details:
  • Drug: Aprepitant
  • Drug: Ondansetron
  • Drug: GW679769
  • Drug: Dexamethasone
    Other Names:
    • Aprepitant
    • Ondansetron
    • GW679769

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

Secondary Outcome Measures :
  1. Routine physical exam findings, vital signs, routine clinical laboratory tests, clinical monitoring and/or observation, and adverse events reporting.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion criteria:

  • 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.

Exclusion criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00169572

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Sponsors and Collaborators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline

Responsible Party: Study Director, GSK Identifier: NCT00169572     History of Changes
Other Study ID Numbers: NKV20001
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: May 10, 2010
Last Verified: May 2010

Keywords provided by GlaxoSmithKline:
Chemotherapy-induced Nausea and Vomiting

Additional relevant MeSH terms:
Signs and Symptoms, Digestive
Signs and Symptoms
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs