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

Last updated: April 10, 2023
Sponsor: Solasia Pharma K.K.
Overall Status: Completed

Phase

3

Condition

Effects Of Chemotherapy

Colic

Lactose Intolerance

Treatment

N/A

Clinical Study ID

NCT01937156
SP-0103
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 Design

Total Participants: 313
Study Start date:
August 01, 2013
Estimated Completion Date:
February 28, 2014

Connect with a study center

  • The 81st Hospital of P.L.A.

    Nanjing, Jiangsu 210002
    China

    Site Not Available

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