Study to Evaluate Anti-emetic Effect of Aprepitant Versus Placebo in Children and Adolescent Receiving Chemotherapy

PHASE3CompletedINTERVENTIONAL
Enrollment

96

Participants

Timeline

Start Date

August 31, 2011

Primary Completion Date

June 30, 2013

Study Completion Date

June 30, 2013

Conditions
Chemotherapy Induced Nausea and Vomiting
Interventions
DRUG

Aprepitant

"The patient on study group with weight category of 15-40 kg will receive:~D1- Dexamethasone 0.15 mg/kg, ondansetron (0.15 mg/kg, single dose), Aprepitant 80 mg; D2- Dexamethasone 0.15 mg/kg, ondansetron (0.15 mg/kg, single dose), Aprepitant 80 mg; D3- Dexamethasone 0.15 mg/kg, ondansetron (0.15 mg/kg, single dose), Aprepitant 80 mg and~The patient with weight category of 41-65 kg in study group will receive:~D1- Dexamethasone 0.15 mg/kg, ondansetron (0.15 mg/kg, single dose), Aprepitant 125 mg; D2- Dexamethasone 0.15 mg/kg, ondansetron (0.15 mg/kg, single dose), Aprepitant 80 mg; D3- Dexamethasone 0.15 mg/kg, ondansetron (0.15 mg/kg, single dose), Aprepitant 80 mg"

DRUG

Placebo

"Patient on control group with weight category of 15-40 kg will receive:~D1- Dexamethasone 0.15 mg/kg, ondansetron (0.15 mg/kg, single dose), Aprepitant placebo 80 mg; D2- Dexamethasone 0.15 mg/kg, ondansetron (0.15 mg/kg, single dose), Aprepitant placebo 80 mg; D3- Dexamethasone 0.15 mg/kg, ondansetron (0.15 mg/kg, single dose), Aprepitant placebo 80 mg; and~The patient on control group with weight category of 41-65 kg will receive:~D1- Dexamethasone 0.15 mg/kg, ondansetron (0.15 mg/kg, single dose), Aprepitant placebo 125 mg; D2- Dexamethasone 0.15 mg/kg, ondansetron (0.15 mg/kg, single dose), Aprepitant placebo 80 mg; D3- Dexamethasone 0.15 mg/kg, ondansetron (0.15 mg/kg, single dose), Aprepitant placebo 80 mg (all are injectable except Aprepitant oral capsule)."

Trial Locations (1)

110029

Dr. BRA IRCH, AIIMS, New Delhi

Sponsors
All Listed Sponsors
collaborator

Dr. Reddy's Laboratories Limited

INDUSTRY

lead

All India Institute of Medical Sciences

OTHER