Phase II Study of SyB D-0701 for Radiotherapy-Induced Nausea and Vomiting (RINV)

PHASE2CompletedINTERVENTIONAL
Enrollment

189

Participants

Timeline

Start Date

May 31, 2011

Primary Completion Date

October 31, 2012

Study Completion Date

October 31, 2012

Conditions
Radiotherapy-induced Nausea and Vomiting (RINV)
Interventions
DRUG

SyB D-0701

Study drug patches \[Low dose group (18.75 mg): SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 patch, High dose group (30.00 mg): SyB D-0701 15 cm2 patch + SyB D-0701 25 cm2 patch\] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.

DRUG

Placebo

Study drug patches (Placebo group: SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 placebo patch) assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.

Trial Locations (21)

Unknown

Research site, Nagoya

Research site, Kashiwa

Research site, Matsuyama

Research site, Kurume

Research site, Maebashi

Research site, Ōta

Research site, Hiroshima

Research site, Sapporo

Research site, Sagamihara

Research site, Yokohama

Research, Kyoto

Research site, Kashihara

Research site, Niigata

Research site, Nakagami

Research site, Sayama

Research site, Hidaka

Research site, Kitaadachi

Research Site, Koshigaya

Reseach site, Tokyo

Research site, Tokyo

Research site, Yamagata

Sponsors
All Listed Sponsors
lead

SymBio Pharmaceuticals

INDUSTRY