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

NCT01937156 | Completed Phase 3

• 1 other identifier: SP-0103
• Study Type: interventional
• Target: 313
• Locations: 1 country
• Sites: 1

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.

Conditions

Chemotherapy-induced Nausea and Vomiting

Outcome Measures

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

  7 days

Study Arms (2)

SP-01

EXPERIMENTAL

Drug: SP-01 (Granisetron Transdermal Delivery System)

Granisetron Hydrochloride Tablet

ACTIVE COMPARATOR

Drug: Granisetron Hydrochloride Tablet

Interventions

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.

SP-01

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.

Granisetron Hydrochloride Tablet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Solasia Pharma K.K.: lead
• Proswell Medical Corporation: collaborator

Study Sites (1)

The 81st Hospital of P.L.A.

Nanjing, Jiangsu, 210002, China

Location

MeSH Terms

Conditions

Vomiting

Interventions

Granisetron

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Indazoles; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Shukui Qin, MD

  The 81st hospital of P.L.A.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2013
• First Posted: September 9, 2013
• Study Start: August 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: February 1, 2014
• Last Updated: April 12, 2023

Record last verified: 2023-04

Locations

CN (1)