Trials / Completed
CompletedNCT04508400
Fosaprepitant for the Prevention of Chemotherapy-induced Nausea and Vomiting in Pediatric Patients
Efficacy, Safety and Feasibility of Fosaprepitant for the Prevention of Chemotherapy-induced Nausea and Vomiting in Pediatric Patients With Solid Tumors Receiving Moderately and Highly Emetogenic Chemotherapy
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 108 (actual)
- Sponsor
- Sun Yat-sen University · Academic / Other
- Sex
- All
- Age
- 6 Months – 17 Years
- Healthy volunteers
- Not accepted
Summary
The purpose is to evaluate the effectiveness and safety of fosaprepitant plus ondansetron with dexamethasone or placebo plus ondansetron with dexamethasone in preventing chemotherapy-induced nausea and vomiting (CINV) with MEC/HE multi-day chemotherapy in children with solid tumors.
Detailed description
Participants will randomly assigned 1:1 to receive double-blind study drug ( fosaprepitant plus ondansetron with dexamethasone OR placebo to fosaprepitant plus ondansetron with dexamethasone). Fosaprepitant or placebo to fosaprepitant were supplied and administered in a blinded manner. Experimental: Participants received a single dose of fosaprepitant (age-based adjustment) administered intravenously (IV) on Day 1 prior to chemotherapy plus ondansetron (weight based) IV with dexamethasone (weight based) iv/po prior to chemotherapy and up to 72 hours after chemotherapy. Placebo Comparator: Participants received a single dose of matched placebo for fosaprepitant administered intravenously (IV) on Day 1 prior to chemotherapy plus ondansetron (weight based) IV with dexamethasone (weight based) iv/po prior to chemotherapy and up to 72 hours after chemotherapy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Fosaprepitant,ondansetron, dexamethasone | Participants will randomly assigned 1:1 to receive double-blind study drug ( fosaprepitant plus ondansetron with dexamethasone OR placebo plus ondansetron with dexamethasone). Fosaprepitant or placebo to fosaprepitant were supplied and administered in a blinded manner. |
| DRUG | placebo ondansetron with dexamethasone | placebo plus ondansetron with dexamethasone |
Timeline
- Start date
- 2022-08-01
- Primary completion
- 2023-06-22
- Completion
- 2023-06-22
- First posted
- 2020-08-11
- Last updated
- 2024-01-09
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04508400. Inclusion in this directory is not an endorsement.