Efficacy and Safety Study of Fentanyl Transdermal (Fentanest®)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00959400
Recruitment Status : Withdrawn
First Posted : August 14, 2009
Last Update Posted : July 16, 2015
Information provided by:
Cristália Produtos Químicos Farmacêuticos Ltda.

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.

Condition or disease Intervention/treatment Phase
Pain Palliative Care Drug: Fentanyl Transdermal Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : November 2009
Actual Primary Completion Date : June 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Fentanyl Transdermal 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.

Primary Outcome Measures :
  1. Primary: formulation tolerability (assessed by adverse events incidence). Co primary: formulation analgesic efficacy (assessed by rescue medication demand). [ Time Frame: 4 weeks folow-up ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00959400

Hospital Universitario da Universidade Federal do Maranhao
Sao Luis, Maranhao, Brazil, 65020-070
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
Instituto Nacional de Cancer - Hospital do Cancer I
Rio de Janeiro, Brazil, 20230-130
Hospital A. C. Camargo
Sao Paulo, Brazil, 01509-010
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo - HCFMUSP
Sao Paulo, Brazil, 05403-000
Sponsors and Collaborators
Cristália Produtos Químicos Farmacêuticos Ltda.

Responsible Party: Eduardo Pagani, CRISTÁLIA PRODUTOS QUÍMICOS FARMACÊUTICOS LTDA Identifier: NCT00959400     History of Changes
Other Study ID Numbers: CRT059
First Posted: August 14, 2009    Key Record Dates
Last Update Posted: July 16, 2015
Last Verified: July 2015

Keywords provided by Cristália Produtos Químicos Farmacêuticos Ltda.:
Fentanyl Transdermal

Additional relevant MeSH terms:
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General