Trials / Terminated
TerminatedNCT02519842
Efficacy and Safety Study of Fosaprepitant (MK-0517) Plus Ondansetron Versus Ondansetron Alone for the Prevention of Chemotherapy-Induced Nausea and Vomiting in Pediatric Participants (MK-0517-044)
A Phase III, Randomized, Placebo-Controlled Clinical Trial to Study the Efficacy and Safety of MK-0517/Fosaprepitant and Ondansetron Versus Ondansetron for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) in Pediatric Subjects Receiving Emetogenic Chemotherapy
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 75 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 17 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the efficacy and safety of fosaprepitant (MK-0517) plus ondansetron versus ondansetron alone for the prevention of chemotherapy-induced nausea and vomiting (CINV) in pediatric participants scheduled to receive chemotherapeutic agent(s) associated with moderate or high risk of causing emesis (vomiting), or chemotherapy agent(s) not previously tolerated due to vomiting. The primary hypothesis is that a single dose of fosaprepitant in combination with ondansetron provides superior control of CINV compared to ondansetron alone as measured by the percentage of participants with a Complete Response (no vomiting, no retching, and no use of rescue medications) in the delayed phase (\>24 to 120 hours) following initiation of emetogneic chemotherapy in Cycle 1.
Detailed description
In Cycle 1, participants will receive double-blind study drug (fosaprepitant plus ondansetron with or without dexamethasone OR placebo to fosaprepitant plus ondansetron with or without dexamethasone). Upon completion of Cycle 1, participants may have the option to continue for up to 5 additional open-label cycles, receiving fosaprepitant plus ondansetron with or without dexamethasone.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Fosaprepitant | |
| DRUG | Placebo for fosaprepitant | |
| DRUG | Ondansetron | |
| DRUG | Dexamethasone | |
| DRUG | 5-HT3 antagonist |
Timeline
- Start date
- 2015-09-14
- Primary completion
- 2017-02-24
- Completion
- 2017-02-24
- First posted
- 2015-08-11
- Last updated
- 2019-03-15
- Results posted
- 2018-03-08
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02519842. Inclusion in this directory is not an endorsement.