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) | Biotech Hunter

Enrollment

389

Participants

Timeline

Start Date

August 31, 2011

Primary Completion Date

November 30, 2012

Study Completion Date

November 30, 2012

Conditions

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

Interventions

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."

Trial Locations (1)

Unknown

Seoul St. Mary's Hospital, Seoul