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

This study has been completed.

First Received: January 6, 2006 Last Updated: May 2, 2008 History of Changes

Sponsored by:	Prostrakan Pharmaceuticals
Information provided by:	Prostrakan Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00273468

Purpose

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

Condition	Intervention	Phase
Chemotherapy-Induced Nausea and Vomiting	Drug: Granisetron	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Nausea and Vomiting

Drug Information available for: Granisetron hydrochloride Granisetron

U.S. FDA Resources

Further study details as provided by Prostrakan Pharmaceuticals:

Primary Outcome Measures:

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:

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
Time from start of chemotherapy to first emetic episode (vomiting/retching)
Percentage of patients achieving CC and CR of CINV during different time periods
Adverse events collected until 14 days after patch removal
Patch adhesion

Estimated Enrollment:	630
Study Start Date:	January 2006
Study Completion Date:	October 2006

Eligibility

Ages Eligible for Study:	15 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Study ID Numbers:	392MD/15/C
Study First Received:	January 6, 2006
Last Updated:	May 2, 2008
ClinicalTrials.gov Identifier:	NCT00273468 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Signs and Symptoms
Neurotransmitter Agents
Vomiting
Signs and Symptoms, Digestive
Antiemetics

Nausea
Peripheral Nervous System Agents
Granisetron
Serotonin

Additional relevant MeSH terms:

Neurotransmitter Agents
Vomiting
Molecular Mechanisms of Pharmacological Action
Signs and Symptoms, Digestive
Physiological Effects of Drugs
Gastrointestinal Agents
Antiemetics
Pharmacologic Actions
Signs and Symptoms

Serotonin Antagonists
Serotonin Agents
Autonomic Agents
Therapeutic Uses
Nausea
Granisetron
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 01, 2009