Study of MK0869 for the Prevention of Chemotherapy-Induced Nausea and Vomiting (0869-071)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00092196
First received: September 21, 2004
Last updated: May 21, 2013
Last verified: May 2013
  Purpose

The purpose of this study is to determine the efficacy and tolerability of an investigational drug for the prevention of chemotherapy-induced nausea and vomiting associated with moderately emetogenic chemotherapy.


Condition Intervention Phase
Nausea
Vomiting
Breast Neoplasms
Drug: MK0869, aprepitant / Duration of Treatment: 3 days
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Open-label Extension to: A Randomized, Double-Blind, Parallel-Group Study Conducted Under In-House Blinding Conditions to Determine the Efficacy and Tolerability of Aprepitant for the Prevention of Chemotherapy-Induced Nausea and Vomiting Associated With Moderately Emetogenic Chemotherapy

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Safety and tolerability

Secondary Outcome Measures:
  • Assessment of adverse experiences using the National Cancer Institute (NCI) criteria

Estimated Enrollment: 820
Study Start Date: December 2002
Primary Completion Date: February 2004 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient with a diagnosis of breast cancer requiring treatment with non-cisplatin moderately emetogenic chemotherapy.
  • Patient must have completed participation in the main study for this protocol.

Exclusion Criteria:

  • Patient has a central nervous system malignancy.
  • Patient will receive radiation to the abdomen or pelvis.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00092196

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00092196     History of Changes
Other Study ID Numbers: 2004_064, MK0869-071
Study First Received: September 21, 2004
Last Updated: May 21, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck Sharp & Dohme Corp.:
Chemotherapy-Induced Nausea and Vomiting

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Nausea
Vomiting
Neoplasms by Site
Breast Diseases
Skin Diseases
Signs and Symptoms, Digestive
Signs and Symptoms
Aprepitant
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents

ClinicalTrials.gov processed this record on April 17, 2014