An Investigational Drug for the Prevention of Chemotherapy-Induced Nausea and Vomiting (MK-0869-071)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00092183
First received: September 21, 2004
Last updated: May 21, 2014
Last verified: May 2014
  Purpose

This protocol will study an investigational drug treatment plan against standard therapy in the prevention of chemotherapy-induced nausea and vomiting in patients diagnosed with breast cancer who are to be treated with up to 4 cycles of non-cisplatin moderately emetogenic chemotherapy.


Condition Intervention Phase
Nausea
Vomiting
Breast Neoplasms
Drug: MK0869, aprepitant / Duration of Treatment: 3 days
Drug: Comparator: ondansetron / Duration of Treatment: 3 days
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: 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:
  • Emesis and use of rescue medication
  • Safety and tolerability

Secondary Outcome Measures:
  • Quality of life

Enrollment: 866
Study Start Date: October 2002
Study Completion Date: February 2004
Primary Completion Date: December 2003 (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.

Exclusion Criteria:

  • Patient has a central nervous system malignancy.
  • Patient will receive radiation to the abdomen or pelvis.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00092183

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

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00092183     History of Changes
Other Study ID Numbers: 0869-071, MK0869-071, 2004_063
Study First Received: September 21, 2004
Last Updated: May 21, 2014
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Nausea
Vomiting
Breast Neoplasms
Signs and Symptoms, Digestive
Signs and Symptoms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Aprepitant
Fosaprepitant
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Neurokinin-1 Receptor Antagonists
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 22, 2014