search
Back to results

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

Primary Purpose

Nausea, Vomiting, Breast Neoplasms

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
MK0869, aprepitant / Duration of Treatment: 3 days
Comparator: ondansetron / Duration of Treatment: 3 days
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Nausea focused on measuring Chemotherapy-Induced Nausea and Vomiting

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Emesis and use of rescue medication
    Safety and tolerability

    Secondary Outcome Measures

    Quality of life

    Full Information

    First Posted
    September 21, 2004
    Last Updated
    May 2, 2017
    Sponsor
    Merck Sharp & Dohme LLC
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00092183
    Brief Title
    An Investigational Drug for the Prevention of Chemotherapy-Induced Nausea and Vomiting (MK-0869-071)
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    October 10, 2002 (Actual)
    Primary Completion Date
    December 1, 2003 (Actual)
    Study Completion Date
    February 11, 2004 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC

    4. Oversight

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Nausea, Vomiting, Breast Neoplasms
    Keywords
    Chemotherapy-Induced Nausea and Vomiting

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    866 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    MK0869, aprepitant / Duration of Treatment: 3 days
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: ondansetron / Duration of Treatment: 3 days
    Primary Outcome Measure Information:
    Title
    Emesis and use of rescue medication
    Title
    Safety and tolerability
    Secondary Outcome Measure Information:
    Title
    Quality of life

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Monitor
    Organizational Affiliation
    Merck Sharp & Dohme LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    15837996
    Citation
    Warr DG, Hesketh PJ, Gralla RJ, Muss HB, Herrstedt J, Eisenberg PD, Raftopoulos H, Grunberg SM, Gabriel M, Rodgers A, Bohidar N, Klinger G, Hustad CM, Horgan KJ, Skobieranda F. Efficacy and tolerability of aprepitant for the prevention of chemotherapy-induced nausea and vomiting in patients with breast cancer after moderately emetogenic chemotherapy. J Clin Oncol. 2005 Apr 20;23(12):2822-30. doi: 10.1200/JCO.2005.09.050. Erratum In: J Clin Oncol. 2005 Aug 20;23(24):5851. Dosage error in published abstract; MEDLINE/PubMed abstract corrected.
    Results Reference
    background
    Available IPD and Supporting Information:
    Available IPD/Information Type
    CSR Snyopsis
    Available IPD/Information URL
    http://www.merck.com/clinical-trials/policies-perspectives.html

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs