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Aprepitant · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Aprepitant | EXPERIMENTAL | It is an double blind randomized placebo controlled trial with age group of 5-18 years and weight between 15-65 kg, who will receive highly emetogenic chemotherapy. Patient who will meet the inclusion criteria will be randomly enrolled in either of the two arm-aprepitant arm and control arm. The patient on aprepitant arm will receive the study drug (aprepitant)along with standard anti-emetic therapy (as per the dosages mentioned in the protocol). |
| Control | PLACEBO_COMPARATOR | It is an double blind randomized placebo controlled trial with age group of 5-18 years and weight between 15-65 kg, who will receive highly emetogenic chemotherapy. Patient who will meet the inclusion criteria will be randomly enrolled in either of the two arm-aprepitant arm and control arm. The patient on the control arm will receive the placebo along with standard anti-emetic therapy (as per the dosages mentioned in the protocol). |
| Name | Type | Description |
|---|---|---|
| Aprepitant | DRUG | 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 |
| Placebo | DRUG | 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). |
Inclusion Criteria: * All subjects must have a confirmed diagnosis of malignancy and receiving highly emetogenic chemotherapy first time (VAC, ABVD and CDDP/Doxorubicin) * Age group 5-18 years with weight between 15-65 kg * Children/adolescents and their caregiver who can understand Hindi or Englis...
Aprepitant is used for chemotherapy induced nausea and vomiting. It is being studied in children and adolescents receiving chemotherapy. The drug is a small molecule in the gastrointestinal therapeutic area and is currently in Phase 3 clinical development.
Aprepitant is being developed by Dr. Reddy's Laboratories Ltd, a pharmaceutical company listed on the stock exchange under the ticker symbol RDY. The company is conducting clinical trials to evaluate the drug's anti-emetic effects.
Aprepitant is in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The Phase 3 trial has been completed, and the drug is being evaluated for its efficacy in treating chemotherapy induced nausea and vomiting.
Aprepitant has one completed Phase 3 clinical trial with the identifier NCT01402024. The trial was a randomized, double-blind, placebo-controlled study that enrolled 96 participants in India. The study evaluated the anti-emetic effect of Aprepitant versus placebo in children and adolescents receiving chemotherapy.
Aprepitant is the generic name of the drug, and Emend is a brand name for the same active ingredient. However, the clinical trial data provided does not specify whether the drug being studied is marketed under the Emend brand. The drug is being developed by Dr. Reddy's Laboratories Ltd.