Efficacy and Safety Study of Fentanyl Transdermal (Fentanest®)

NCT ID: NCT00959400

Last Updated: 2015-07-16

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-30

Brief Summary

Eligible patients who agree to participate will migrate from oral opioids to transdermal patches and be followed for four weeks. Oral morphine will be provided as pain rescue medication. The patients will inform the adverse events and rescue medication consumption. The number of Fentanest® patches will be adjusted every visit aiming to reduce the rescue medication consumption and adverse events to a minimum. The WHO-QOL- bref (quality of life questionary) will be filled before and after the use of Fentanest®. Patients showing benefit are eligible to a 3 weeks compassionate study.

Conditions

Pain; Palliative Care

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Fentanyl Transdermal

Group Type: EXPERIMENTAL

Fentanyl Transdermal

Intervention Type: DRUG

Fentanest® 25 mcg/h. Each patch delivers 25 mcg of fentanyl per hour continuously for 72 hours. Therefore paches must be changed every 3 days.

Interventions

Fentanyl Transdermal

Fentanest® 25 mcg/h. Each patch delivers 25 mcg of fentanyl per hour continuously for 72 hours. Therefore paches must be changed every 3 days.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Male or female outpatients aged from 18 to 70 years with cancer chronic pain who received in the last 4 weeks at least 40 mg of oral morphine or equianalgesic dose of other opioids. If using adjuvant analgesics, these must be in stable doses in the last 4 weeks.

Exclusion Criteria

• Life expectancy bellow 4 months;
• Karnofsky score < 60;
• Hypersensitivity to opioids or patches;
• Acute pain;
• Non cancer pain;
• Increased intracranial pressure;
• Conditions that prevent the patient to understand the study directions and/or give his consent;
• Neuromuscular disorders with increased risk of respiratory depression;
• Impossibility to receive rescue oral morphine; active infections;
• Fever;
• Pregnancy and nursing;
• Uncontrolled diabetes mellitus or arterial hypertension;
• Need of anticoagulation;
• Need to operate machines or vehicles;
• Important skin disorders;
• History of severe allergic reactions;
• BMI ≥ 35;
• Safety exams outrange;
• Participation in another clinical trial within the last 2 months;
• Investigator´s opinion.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cristália Produtos Químicos Farmacêuticos Ltda.

INDUSTRY

Sponsor Role: lead

Responsible Party

CRISTÁLIA PRODUTOS QUÍMICOS FARMACÊUTICOS LTDA

Locations

Hospital Universitario da Universidade Federal do Maranhao

São Luís, Maranhão, Brazil

Instituto Nacional de Cancer - Hospital do Cancer I

Rio de Janeiro, Rio de Janeiro, Brazil

Hospital das Clinicas da Faculdade de Medicina da Universidade Estadual Paulista "Julio de Mesquita Filho" - Campus de Botucatu - Unesp

Botucatu, São Paulo, Brazil

Hospital A. C. Camargo

São Paulo, São Paulo, Brazil

Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo - HCFMUSP

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

CRT059

Identifier Type: -

Identifier Source: org_study_id