A Randomized Controlled Trial of SP-01 (Granisetron Transdermal Delivery System) in Chemotherapy-induced Nausea and Vomiting

PHASE3CompletedINTERVENTIONAL
Enrollment

313

Participants

Timeline

Start Date

August 31, 2013

Primary Completion Date

January 31, 2014

Study Completion Date

February 28, 2014

Conditions
Chemotherapy-induced Nausea and Vomiting
Interventions
DRUG

SP-01 (Granisetron Transdermal Delivery System)

SP-01 will be applied to the upper arm 24-48 hours before the start of chemotherapy, and left in place for 7 days.

DRUG

Granisetron Hydrochloride Tablet

Granisetron hydrochloride 1 mg tablets will be administered 1 hour before administration of chemotherapy at the first time, then taken 12 hours after the first dose later; 2 mg/day bid, for ≥ 2 days.

Trial Locations (1)

210002

The 81st Hospital of P.L.A., Nanjing

Sponsors
All Listed Sponsors
collaborator

Proswell Medical Corporation

INDUSTRY

lead

Solasia Pharma K.K.

INDUSTRY