Efficacy and Safety Study of Fentanyl Transdermal (Fentanest®)

This study is not yet open for participant recruitment.

Verified by Cristália Produtos Químicos Farmacêuticos Ltda., August 2009

First Received: August 13, 2009 No Changes Posted

Sponsor:	Cristália Produtos Químicos Farmacêuticos Ltda.
Information provided by:	Cristália Produtos Químicos Farmacêuticos Ltda.
ClinicalTrials.gov Identifier:	NCT00959400

Purpose

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.

Condition	Intervention	Phase
Pain Palliative Care	Drug: Fentanyl Transdermal	Phase III

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study

Resource links provided by NLM:

MedlinePlus related topics: Palliative Care

Drug Information available for: Fentanyl Fentanyl Citrate

U.S. FDA Resources

Further study details as provided by Cristália Produtos Químicos Farmacêuticos Ltda.:

Primary Outcome Measures:

Primary: formulation tolerability (assessed by adverse events incidence). Co primary: formulation analgesic efficacy (assessed by rescue medication demand). [ Time Frame: 4 weeks folow-up ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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). [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	120
Study Start Date:	November 2009
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Fentanyl Transdermal: Experimental	Drug: 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.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00959400

Contacts

Contact: Eduardo Pagani, MD PhD	+55 11 37236461	pagani@cristalia.com.br
Contact: Juliana Ferreira Goes, Pharmacist	+55 11 37236456	juliana.goes@cristalia.com.br

Locations

Brazil
Instituto Nacional de Cancer - Hospital do Cancer I
Rio de Janeiro, Brazil, 20230-130
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo - HCFMUSP
Sao Paulo, Brazil, 05403-000
Hospital A. C. Camargo
Sao Paulo, Brazil, 01509-010
Brazil, Maranhao
Hospital Universitario da Universidade Federal do Maranhao
Sao Luis, Maranhao, Brazil, 65020-070
Brazil, Sao Paulo
Hospital das Clinicas da Faculdade de Medicina da Universidade Estadual Paulista "Julio de Mesquita Filho" - Campus de Botucatu - Unesp
Botucatu, Sao Paulo, Brazil, 18618-970

Sponsors and Collaborators

Cristália Produtos Químicos Farmacêuticos Ltda.

More Information

No publications provided

Responsible Party:	CRISTÁLIA PRODUTOS QUÍMICOS FARMACÊUTICOS LTDA ( Eduardo Pagani )
Study ID Numbers:	CRT059
Study First Received:	August 13, 2009
Last Updated:	August 13, 2009
ClinicalTrials.gov Identifier:	NCT00959400 History of Changes
Health Authority:	Brazil: Ethics Committee; Brazil: National Health Surveillance Agency

Keywords provided by Cristália Produtos Químicos Farmacêuticos Ltda.:

Fentanyl Transdermal
Pain
Cancer

Additional relevant MeSH terms:

Anesthetics, Intravenous
Fentanyl
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Narcotics
Pharmacologic Actions
Adjuvants, Anesthesia

Sensory System Agents
Anesthetics, General
Therapeutic Uses
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on February 08, 2010