To Study the Safety and Effectiveness of a Granisetron Patch to Treat Chemotherapy-Induced Nausea and Vomiting (CINV)

Chemotherapy-induced Nausea and Vomiting Clinical Trial

Official title:

A Randomised, Active Control, Double-blind, Double-dummy, Parallel-group, Multi-national Study to Assess the Efficacy, Tolerability and Safety of the Granisetron Transdermal Delivery System in Chemotherapy-induced Nausea and Vomiting (CINV) Associated With the Administration of Moderately or Highly Emetogenic Multi-day Chemotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00273468
• Other study ID #: 392MD/15/C
• Status: Completed
• Phase: Phase 3
• Start date: January 2006
• Est. completion date: October 2006

Study information

• Verified date: June 2024
• Source: Kyowa Kirin Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To study the safety and effectiveness of a granisetron patch to treat Chemotherapy-Induced Nausea and Vomiting (CINV)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 630
• Est. completion date: October 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

Inclusion Criteria:

• Patients must be of non-childbearing potential and female patients must have a negative pregnancy test at the Screening Visit

• Histologically and/or cytologically confirmed cancer with ECOG =2

• Life expectancy of = 3 months

• Assigned to receive the first cycle of a new multi-day chemotherapy regimen including the daily administration of cytotoxic agent(s) with the emetogenic potential of level 3-5 (Hesketh Classification) on 3-5 days

Exclusion Criteria:

• Hypersensitivity to adhesive plasters

• Contraindications to 5-HT3 receptor antagonists

• Clinically relevant abnormal laboratory values or hepatic, renal, infectious, neurological or psychiatric disorders or any other major systemic illness at the discretion of the Investigator

• Any cause for nausea and vomiting other than CINV

• Clinically relevant abnormal ECG parameters

• Concomitant radiotherapy of total body, brain or upper abdomen within one week of study entry or planned during the study

• A patient taking a medication to control the symptoms of a brain tumour, brain metastasis or seizure disorder

Related Conditions & MeSH terms

• Chemotherapy-induced Nausea and Vomiting
• Nausea
• Vomiting

Intervention

Drug:
• Granisetron

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kyowa Kirin Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients achieving Complete Control of CINV from the first administration until 24 h after the last administration of the moderately or highly emetogenic chemotherapy
Secondary	Times from start of chemotherapy to treatment failure for complete control (CC) and complete response (CR)
Secondary	Time from start of chemotherapy to first administration of rescue medication
Secondary	Time from start of chemotherapy to first emetic episode (vomiting/retching)
Secondary	Percentage of patients achieving CC and CR of CINV during different time periods
Secondary	Adverse events collected until 14 days after patch removal
Secondary	Patch adhesion