Study of MK0869 for Chemotherapy-Induced Nausea and Vomiting in Adolescent Patients - Full Text View

Sponsor:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00080444

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 III

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:

MedlinePlus related topics: Nausea and Vomiting

Drug Information available for: Dexamethasone Dexamethasone acetate Doxiproct plus Ondansetron hydrochloride Ondansetron Aprepitant Dexamethasone Sodium Phosphate

U.S. FDA Resources

Further study details as provided by Merck:

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:

Other Name: MK0869

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

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

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Publications:

Gore L, Chawla S, Petrilli A, Hemenway M, Schissel D, Chua V, Carides AD, Taylor A, Devandry S, Valentine J, Evans JK, Oxenius B; Adolescent Aprepitant in Cancer Study Group. Aprepitant in adolescent patients for prevention of chemotherapy-induced nausea and vomiting: a randomized, double-blind, placebo-controlled study of efficacy and tolerability. Pediatr Blood Cancer. 2009 Feb;52(2):242-7.

Responsible Party:	Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT00080444 History of Changes
Other Study ID Numbers:	2004_099, Formerly-0304AHEC, MK0869-097
Study First Received:	March 31, 2004
Last Updated:	January 21, 2010
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 February 09, 2012