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

Chemotherapy-induced Nausea and Vomiting Clinical Trial

Official title:

A Randomized, Active-control, Double-blind, Double-dummy, Parallel-group, Multi-center Study to Assess the Efficacy and Safety of SP-01 (Granisetron Transdermal Delivery System) in Chemotherapy-induced Nausea and Vomiting Associated With the Administration of Moderately or Highly Emetogenic (ME or HE) Multi-day Chemotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01937156
• Other study ID #: SP-0103
• Status: Completed
• Phase: Phase 3
• Start date: August 2013
• Est. completion date: February 2014

Study information

• Verified date: April 2023
• Source: Solasia Pharma K.K.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the efficacy and safety of SP-01 in chemotherapy-induced nausea and vomiting (CINV) associated with the administration of moderately or highly emetogenic (ME or HE) multi-day chemotherapy，which will provide scientific and reliable clinical data in the drug registration in China.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 313
• Est. completion date: February 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male or female aged = 18years

• Histologically and/or cytologically confirmed cancer

• The physical status score ECOG = 2

• Life expectancy of =3 months

• Will receive multi-day ME/HE chemotherapy (=2 days) with the emetogenic potential of level 3-5

• In accordance with the indication of chemotherapy and basic requirements;

• Peripheral Haematology: Hb = 9.0 g/dL, absolute neutrophil count = 1.5×10e9/L, platelet count = 80×10e9/L

• Blood biochemistry: Total bilirubin < 1.25×ULN, ALT and AST = 2.5×ULN; if liver metastasis, ALT and AST < 5×ULN, Creatinine = 1×ULN, basic normal serum electrolyte (Na, Ka, Cl, Ca)

• Other important organs function normally

• Subjects voluntarily participate and signed the informed consent form

Related Conditions & MeSH terms

• Chemotherapy-induced Nausea and Vomiting
• Nausea
• Vomiting

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	The 81st Hospital of P.L.A.	Nanjing	Jiangsu

Sponsors (2)

Lead Sponsor	Collaborator
Solasia Pharma K.K.	Proswell Medical Corporation

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of subjects achieving Complete Control (CC) of CINV from the first administration until 24 hour after the last administration of ME or HE multi-day chemotherapy		7 days