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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
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
The 81st Hospital of P.L.A.
Nanjing, Jiangsu, China
Start Date
August 1, 2013
Primary Completion Date
January 1, 2014
Completion Date
February 1, 2014
Last Updated
April 12, 2023
313
ACTUAL participants
SP-01 (Granisetron Transdermal Delivery System)
DRUG
Granisetron Hydrochloride Tablet
DRUG
Lead Sponsor
Solasia Pharma K.K.
Collaborators
NCT02106494
NCT04472143
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT03245918