Efficacy and Safety Study of Fentanyl Transdermal (Fentanest®)
Information source: Cristália Produtos Químicos Farmacêuticos Ltda.
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain; Palliative Care
Intervention: Fentanyl Transdermal (Drug)
Phase: Phase 3
Status: Not yet recruiting
Sponsored by: Cristália Produtos Químicos Farmacêuticos Ltda. Overall contact:
Eduardo Pagani, MD PhD, Phone: +55 11 37236461, Email: pagani@cristalia.com.br
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.
Clinical Details
Study design: Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Primary outcome: Primary: formulation tolerability (assessed by adverse events incidence).
Co primary: formulation analgesic efficacy (assessed by rescue medication demand).
Secondary outcome: Establish the correspondence between the dose of oral opioids available in Brazil and number of patches required. Establish directions for secure and effective migration from oral opioids to this formulation. Quality of life improvement (WHO-QOL-bref).
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
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.
Locations and Contacts
Eduardo Pagani, MD PhD, Phone: +55 11 37236461, Email: pagani@cristalia.com.br
Instituto Nacional de Cancer - Hospital do Cancer I, Rio de Janeiro 20230-130, Brazil
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo - HCFMUSP, Sao Paulo 05403-000, Brazil
Hospital A. C. Camargo, Sao Paulo 01509-010, Brazil
Hospital Universitario da Universidade Federal do Maranhao, Sao Luis, Maranhao 65020-070, Brazil
Hospital das Clinicas da Faculdade de Medicina da Universidade Estadual Paulista "Julio de Mesquita Filho" - Campus de Botucatu - Unesp, Botucatu, Sao Paulo 18618-970, Brazil
Additional Information
Starting date: November 2009
Last updated: August 13, 2009
|
