Chemotherapy-induced Acute or Delayed Nausea and Vomiting (CINV) Clinical Trial
Official title:
Randomized Study of the Efficacy and Safety of Transdermal Granisetron Compared With Intravenous and Oral Agent in the Control of Nausea and Vomiting Induced by Moderately Emetogenic Chemotherapy
Multicenter, randomized, open-label, paralled-group, active-controlled study. The study is
to demonstrate non-inferiority of the Granisetron Transdermal Delivery System (GTDS)
compared with the intravenous and oral Granisetron in the prevention of CINV associated with
moderately emetogenic Chemotherapy.
Patients scheduled to receive the one cycle of a ME chemotherapy regimen administered for
1-4 days will attend a Screening Visit 2 to 28 days before start of ME chemotherapy.
Eligible patients will be randomized to 1 of 2 treatment groups at the Randomization Visit
(1 to 2 days prior to ME chemotherapy).
- Sancuso patch
- Kytril inj.+Kytril tab.
The patch will be applied 2days (48-24h) prior to first daily dose of the moderately
emetogenic chemotherapy regimen and remain in place for 6 days. The patient will be assessed
daily until 4days after first chemotherapy administration. Adverse Events (AEs) will be
collected until 14 days after the final dose of IP. Non-serious AEs will be followed-up
until 14 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 | |
|---|---|---|---|
| Completed |
NCT01659775 -
Phase 4 Trial to Evaluate the Efficacy and Safety of Sancuso Patch in Chemotherapy-induced Nausea and Vomiting Associated With the Administration of Highly Emetogenic Chemotherapy (HEC)
|
Phase 4 |