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

Sponsored by:	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

MedlinePlus related topics: Nausea and Vomiting

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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety Study
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

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

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 indexed to this study:

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:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2004_099, Formerly-0304AHEC, MK0869-097
Study First Received:	March 31, 2004
Last Updated:	July 31, 2008
ClinicalTrials.gov Identifier:	NCT00080444
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Dexamethasone
Signs and Symptoms
Vomiting
Signs and Symptoms, Digestive
Nausea

Ondansetron
Serotonin
Dexamethasone acetate
Aprepitant

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Psychotropic Drugs
Antiemetics
Hormones
Serotonin Antagonists
Therapeutic Uses
Antipruritics
Dermatologic Agents

Tranquilizing Agents
Antineoplastic Agents, Hormonal
Gastrointestinal Agents
Central Nervous System Depressants
Antipsychotic Agents
Glucocorticoids
Pharmacologic Actions
Serotonin Agents
Autonomic Agents
Anti-Anxiety Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009