Trial | NCT01937156  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    granisetron ...

  • Study Participants

    313
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.
Study Started
Aug 31
2013
Primary Completion
Jan 31
2014
Study Completion
Feb 28
2014
Last Update
Apr 12
2023

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.

SP-01 Experimental

Granisetron Hydrochloride Tablet Active Comparator

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
No Results Posted