A Randomized Controlled Trial of SP-01 (Granisetron Transdermal Delivery System) in Chemotherapy-induced Nausea and Vomiting
NCT ID: NCT01937156
Last Updated: 2023-04-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
313 participants
INTERVENTIONAL
2013-08-31
2014-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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SP-01
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.
Granisetron Hydrochloride Tablet
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Proswell Medical Corporation
INDUSTRY
Solasia Pharma K.K.
INDUSTRY
Responsible Party
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Principal Investigators
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Shukui Qin, MD
Role: PRINCIPAL_INVESTIGATOR
The 81st hospital of P.L.A.
Locations
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The 81st Hospital of P.L.A.
Nanjing, Jiangsu, China
Countries
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Other Identifiers
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SP-0103
Identifier Type: -
Identifier Source: org_study_id
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