Chemotherapy-induced Acute or Delayed Nausea and Vomiting (CINV) Clinical Trial
Official title:
A Multicenter, Randomized, Open-label, Paralleled-group, Active-controlled, Phase IV Study to Evaluate the Efficacy and Safety of Sancuso Patch (Granisetron) in Chemotherapy-induced Nausea and Vomiting (CINV) Associated With the Administration of Highly Emetogenic (HE) Chemotherapy
This is a multicenter, randomized, open-label, paralleled-group, active-controlled study.
The study is to demonstrate non-inferiority of the Granisetron Transdermal Delivery System
(GTDS) efficacy compared with the ondansetron efficacy with regard to Complete Response (CR)
of Chemotherapy Induced Nausea and Vomiting (CINV).
Patients scheduled to receive the one cycle of a HE chemotherapy regimen administered for
1-5 days will attend a Screening Visit 2 to 14 days before start of HE chemotherapy.
Eligible patients will be randomized to 1 of 2 treatment groups at the Randomization Visit
(1 to 2 days prior to HE chemotherapy).
- Sancuso patch
- Zofran inj. + Zofran tab.
The patch will be applied 2days (48-24h) prior to first daily dose of the highly emetogenic
chemotherapy regimen and remain in place for 5 days after start of chemotherapy. The patient
will be assessed daily until 5days after first chemotherapy administration. Adverse Events
(AEs) will be collected until 2 days after the final dose of IP. Non-serious AEs will be
followed-up until 2 days after the final dose of IP. Serious adverse events will be
followed-up until they are resolved, stable or until the patient is lost to follow-up.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT01662687 -
Phase 4 Trial to Evaluate the Efficacy and Safety of Sancuso Patch in CINV (Chemotherapy-induced Nausea and Vomiting) Associated With the Administration of MEC (Moderately Emetogenic Chemotherapy)
|
Phase 4 |