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)

PHASE4UnknownINTERVENTIONAL
Enrollment

276

Participants

Timeline

Start Date

February 29, 2012

Primary Completion Date

October 31, 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 Kytril groups and received the assigned treatment for 4days.~Experimental arm: Sancuso patch (34.3mg) applied to upper, outer arm 2days (48-24 hours) prior to start of chemotherapy."

DRUG

Kytril inj.+Kytril tab.

"Eligible patients were randomized to Sancuso patch or Kytril groups and received the assigned treatment for 4days.~Active Comparator arm:~* Kytril inj. 3mg: administered by intravenous infusion at least 5 minutes, just before the first chemotherapy (Day 1).~* Kytril tab. 1mg: administered twice a day by orally at Day 2\~4."

Trial Locations (1)

Unknown

RECRUITING

Samsung Medical Center, Seoul

Sponsors

Lead Sponsor

All Listed Sponsors
lead

LG Life Sciences

INDUSTRY

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) | Biotech Hunter | Biotech Hunter