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

Phase 3

Completed

• Conditions: Chemotherapy-induced Nausea and Vomiting
• Interventions: Drug: SP-01 (Granisetron Transdermal Delivery System); Drug: Granisetron Hydrochloride Tablet

• Registration Number: NCT01937156
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2013-09-03
• Study First Submitted QC: 2013-09-03
• Study First Posted: 2013-09-09
• Primary Completion: 2014-01
• Study Completion: 2014-02
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-10
• Last Update Posted: 2023-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 313

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SP-01	SP-01 (Granisetron Transdermal Delivery System)	-
Granisetron Hydrochloride Tablet	Granisetron Hydrochloride Tablet	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

The 81st Hospital of P.L.A.; 🇨🇳 Nanjing, Jiangsu, China