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Completed

NCT Number: NCT01937156

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

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.

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Key information

Conditions

Chemotherapy-induced Nausea and Vomiting Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

The 81st Hospital of P.L.A.

Nanjing, Jiangsu, 210002, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SP-01 (Granisetron Transdermal Delivery System)

Drug

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

Granisetron Hydrochloride Tablet

Drug

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.

Primary outcomes

  1. 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

    Time frame: 7 days

Sponsors and collaborators

Lead sponsor

Solasia Pharma K.K.

Industry

Collaborators

  • Proswell Medical Corporation

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Sep 9, 2013
Registry last updated
Apr 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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