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)

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 389 (actual)
• Sponsor: LG Life Sciences · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Chemotherapy-induced Acute or Delayed Nausea and Vomiting (CINV)

Interventions

Type	Name	Description
DRUG	Sancuso patch	Eligible patients were randomized to Sancuso patch or Zofran groups and received the assigned treatment for 5days. Experimental arm: Sancuso patch (34.3mg) applied to upper, outer arm 2days (48-24hours) prior to start of chemotherapy.
DRUG	Zofran inj.+Zofran tab.	Eligible patients were randomized to Sancuso patch or Zofran groups and received the assigned treatment for 5days. Active Comparator arm: administered intravenously (24mg or 32mg) on Day 1 of chemotherapy and orally (8mg bid) on Day 2-5.

Timeline

• Start date: 2011-08-01
• Primary completion: 2012-11-01
• Completion: 2012-11-01
• First posted: 2012-08-08
• Last updated: 2013-07-25

Locations

1 site across 1 country: South Korea