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

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

Sponsors

Lead Sponsor: Solasia Pharma K.K.

Collaborator: Proswell Medical Corporation

Source Solasia Pharma K.K.
Brief 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.

Overall Status Completed
Start Date August 2013
Completion Date February 2014
Primary Completion Date January 2014
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
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
Enrollment 313
Condition
Intervention

Intervention Type: Drug

Intervention Name: SP-01 (Granisetron Transdermal Delivery System)

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

Arm Group Label: SP-01

Intervention Type: Drug

Intervention Name: Granisetron Hydrochloride Tablet

Description: 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.

Arm Group Label: Granisetron Hydrochloride Tablet

Eligibility

Criteria:

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Shukui Qin, MD Principal Investigator The 81st hospital of P.L.A.
Location
Facility: The 81st Hospital of P.L.A.
Location Countries

China

Verification Date

April 2014

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: SP-01

Type: Experimental

Label: Granisetron Hydrochloride Tablet

Type: Active Comparator

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Prevention

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov