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

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 Overview

• Status: Completed
• Conditions: Chemotherapy-induced Nausea and Vomiting
• Intervention / Treatment: Drug: SP-01 (Granisetron Transdermal Delivery System); Drug: Granisetron Hydrochloride Tablet

• Study Type: Interventional
• Enrollment (Actual): 313
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210002
      • The 81st Hospital of P.L.A.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SP-01	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.
Active Comparator: Granisetron Hydrochloride Tablet	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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Solasia Pharma K.K.
• Collaborators: Proswell Medical Corporation
• Investigators: Principal Investigator: Shukui Qin, MD, The 81st Hospital of P.L.A.

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): February 1, 2014

Study Registration Dates

• First Submitted: September 3, 2013
• First Submitted That Met QC Criteria: September 3, 2013
• First Posted (Estimate): September 9, 2013

Study Record Updates

• Last Update Posted (Actual): April 12, 2023
• Last Update Submitted That Met QC Criteria: April 10, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Nausea; Vomiting; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Serotonin Agents; Serotonin Antagonists; Granisetron
• Other Study ID Numbers: SP-0103