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

Phase 3

Completed

• Conditions: Chemotherapy-induced Nausea and Vomiting

• Registration Number: NCT00273468
• Lead Sponsor: Kyowa Kirin Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01
• Study First Submitted: 2006-01-06
• Study First Submitted QC: 2006-01-06
• Study First Posted: 2006-01-09
• Study Completion: 2006-10
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-14
• Last Update Posted: 2024-06-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 630

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Times from start of chemotherapy to treatment failure for complete control (CC) and complete response (CR)
Time from start of chemotherapy to first administration of rescue medication
Adverse events collected until 14 days after patch removal
Time from start of chemotherapy to first emetic episode (vomiting/retching)
Percentage of patients achieving CC and CR of CINV during different time periods
Patch adhesion