Study of MK0869 for Chemotherapy-Induced Nausea and Vomiting in Adolescent Patients (0869-097)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00080444
First received: March 31, 2004
Last updated: May 21, 2014
Last verified: May 2014
  Purpose

To demonstrate that MK0869 prevents nausea and vomiting caused by emetogenic cancer chemotherapy in adolescent patients.


Condition Intervention Phase
Vomiting
Drug: aprepitant
Drug: Comparator: ondansetron and dexamethasone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study, Conducted Under In-House Blinding Conditions, to Examine the Safety, Tolerability, and Efficacy of Aprepitant for the Prevention of Chemotherapy-Induced Nausea and Vomiting Associated With Emetogenic Chemotherapy in Adolescent Patients

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Drug-related adverse experiences

Secondary Outcome Measures:
  • Serious adverse experiences including drug related and discontinuation of the study due to drug related adverse experiences
  • Efficacy against nausea and vomiting during 4 days of treatment

Enrollment: 50
Study Start Date: April 2004
Study Completion Date: March 2007
Intervention Details:
    Drug: aprepitant
    Other Name: MK0869
    Drug: Comparator: ondansetron and dexamethasone
Detailed Description:

The duration of treatment is 4 days, up to 10 cycles.

  Eligibility

Ages Eligible for Study:   12 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Patient is to be treated with an emetogenic chemotherapy regimen that includes either cisplatin, cyclophosphamide, or carboplatin, for a documented solid malignancy, for either 1 day or 2 consecutive days OR Patient did not tolerate a previously administered chemotherapy regimen, for a documented solid malignancy, secondary to nausea and/or vomiting that is planned to be repeated.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00080444

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: NCT00080444     History of Changes
Other Study ID Numbers: 0869-097, Formerly-0304AHEC, MK0869-097, 2004_099
Study First Received: March 31, 2004
Last Updated: May 21, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Dexamethasone acetate
Dexamethasone
Ondansetron
Aprepitant
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antipruritics
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents

ClinicalTrials.gov processed this record on July 29, 2014