A Study of the Safety and Efficacy of Aprepitant for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) in Pediatric Participants (MK-0869-208)

Chemotherapy Induced Nausea and Vomiting Clinical Trial

Official title:
A Phase III, Randomized, Double-Blind, Active Comparator-Controlled Clinical Trial, Conducted Under In-House Blinding Conditions, to Examine the Efficacy and Safety of Aprepitant for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) in Pediatric Patients

Status Completed

Clinical Trial Summary

This study will compare the safety and efficacy of a three-day oral aprepitant regimen (aprepitant plus ondansetron) to ondansetron alone in the prevention of chemotherapy-induced nausea and vomiting (CINV) in the 120 hours following the initiation of chemotherapy in pediatric participants. Those who complete this first cycle of treatment and meet certain eligibility criteria will have the option of continuing for 5 additional cycles of open-label aprepitant.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01362530
Study type	Interventional
Source	Merck Sharp & Dohme Corp.
Contact
Status	Completed
Phase	Phase 3
Start date	September 13, 2011
Completion date	August 16, 2013

View Details

See also
Status	Clinical Trial	Phase
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Completed	`NCT01596400` - Safety and Pharmacokinetics of Sancuso and IV Granisetron in Patients Aged 13 to 17 Years	Phase 1
Not yet recruiting	`NCT04873284` - Comparative Study of Fosaprepitant and Aprepitant for the Prevention of Chemotherapy-induced Nausea and Vomiting in Pediatric Caner Patients	N/A
Completed	`NCT00642512` - Dronabinol Versus Standard Ondansetron Antiemetic Therapy in Preventing Delayed-Onset Chemotherapy-Induced Nausea and Vomiting	Phase 3
Recruiting	`NCT02097823` - Pilot Study of Olanzapine and Aprepitant to Prevent Nausea and Vomiting in Children Receiving Chemotherapy	Phase 2
Completed	`NCT01402024` - Study to Evaluate Anti-emetic Effect of Aprepitant Versus Placebo in Children and Adolescent Receiving Chemotherapy	Phase 3
Completed	`NCT00211601` - Study of Chemotherapy and Patient Health Outcomes for Nausea and Emesis (0000-041)	N/A
Completed	`NCT05792228` - A Standardized Intervention to Improve the Management of Chemotherapy-induced Nausea and Vomiting	N/A
Withdrawn	`NCT01596413` - Pharmacokinetics and Safety of Sancuso and IV Granisetron in Pediatrics Aged 6 to 12 Years	Phase 1
Withdrawn	`NCT01596426` - Safety and Pharmacokinetics of Sancuso and IV Granisetron in Patients Aged 2 to 5 Years	Phase 1