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Completed

NCT Number: NCT00104403

Study Of Prevention of Chemo-Induced Nausea and Vomiting Caused By Moderately Emetogenic Chemotherapy

This study was designed to assess the safety and efficacy of different dosages and administration schedules of an investigational agent administered over 3 days when added to standard therapy used in the prevention of chemotherapy-induced nausea and vomiting in cancer patients. Subjects will be asked to complete daily diaries while on study medication. In addition subjects will be required to return to the investigational site several times during the course of the study for follow up safety assessments which may include blood samples for hematology and chemistry evaluations as well as physical exams. A final assessment will be preformed on study Day 20-30 at which time the subject will complete the study.

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Key information

Conditions

Nausea and Vomiting, Chemotherapy-Induced Chemotherapy-induced Nausea and Vomiting Nausea Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

GSK Investigational Site, Capital Federal, Buenos Aires, Argentina

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About this study

A Phase II Multicenter, Randomized, Double-blind, Placebo-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 Moderately Emetogenic Chemotherapy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Willing to provide a written informed consent prior to receiving any study-specific procedures or assessments.
  • Diagnosed with a solid malignant tumor 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 enrollment 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.

Treatment and study plan

GW679769

Drug

Dexamethasone

Drug

Ondansetron Hydrochloride

Drug

Other names: GW679769, Dexamethasone

Primary outcomes

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

Secondary outcomes

  1. Based on routine physical exam findings, vital signs, routine clinical laboratory tests, clinical monitoring and/or observation, and adverse events reporting performed during scheduled visits.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

A Phase II Multicenter, Randomized, Double-blind, Placebo-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

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Mar 1, 2005
Registry last updated
Apr 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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