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Completed

NCT Number: NCT00273468

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

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

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Key information

Conditions

Chemotherapy-induced Nausea and Vomiting Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

15 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Granisetron

Drug

Primary outcomes

  1. 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 outcomes

  1. Times from start of chemotherapy to treatment failure for complete control (CC) and complete response (CR)

  2. Time from start of chemotherapy to first administration of rescue medication

  3. Time from start of chemotherapy to first emetic episode (vomiting/retching)

  4. Percentage of patients achieving CC and CR of CINV during different time periods

  5. Adverse events collected until 14 days after patch removal

  6. Patch adhesion

Sponsors and collaborators

Lead sponsor

Kyowa Kirin Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2006
Study completion
2006
First posted
Jan 9, 2006
Registry last updated
Jun 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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