MedTrace Logo

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

NCT01937156 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 313

Last updated 2023-04-12

No results posted yet for this study

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

Interventions

DRUG

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.

DRUG

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.

Sponsors & Collaborators

  • Proswell Medical Corporation

    collaborator INDUSTRY

  • Solasia Pharma K.K.

    lead INDUSTRY

Principal Investigators

  • Shukui Qin, MD · The 81st hospital of P.L.A.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2014-01-31
Completion
2014-02-28

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01937156 on ClinicalTrials.gov