Back to resultsA Randomized Controlled Trial of SP-01 (Granisetron Transdermal Delivery System) in Chemotherapy-induced Nausea and Vomiting
Primary Purpose
Chemotherapy-induced Nausea and Vomiting
Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
SP-01 (Granisetron Transdermal Delivery System)
Granisetron Hydrochloride Tablet
Sponsored by
About this trial
This is an interventional prevention trial for Chemotherapy-induced Nausea and Vomiting
Eligibility 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
Sites / Locations
- The 81st Hospital of P.L.A.
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
SP-01
Granisetron Hydrochloride Tablet
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT01937156
First Posted
September 3, 2013
Last Updated
April 10, 2023
Sponsor
Solasia Pharma K.K.
Collaborators
Proswell Medical Corporation
1. Study Identification
Unique Protocol Identification Number
NCT01937156
Brief Title
A Randomized Controlled Trial of SP-01 (Granisetron Transdermal Delivery System) in Chemotherapy-induced Nausea and Vomiting
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
February 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Solasia Pharma K.K.
Collaborators
Proswell Medical Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chemotherapy-induced Nausea and Vomiting
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
313 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SP-01
Arm Type
Experimental
Arm Title
Granisetron Hydrochloride Tablet
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
SP-01 (Granisetron Transdermal Delivery System)
Intervention Description
SP-01 will be applied to the upper arm 24-48 hours before the start of chemotherapy, and left in place for 7 days.
Intervention Type
Drug
Intervention Name(s)
Granisetron Hydrochloride Tablet
Intervention Description
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 Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shukui Qin, MD
Organizational Affiliation
The 81st hospital of P.L.A.
Official's Role
Principal Investigator
Facility Information:
Facility Name
The 81st Hospital of P.L.A.
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210002
Country
China
12. IPD Sharing Statement
Learn more about this trial
A Randomized Controlled Trial of SP-01 (Granisetron Transdermal Delivery System) in Chemotherapy-induced Nausea and Vomiting
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