Efficacy and Safety Study of Fentanyl Transdermal (Fentanest®)

July 15, 2015 updated by: Cristália Produtos Químicos Farmacêuticos Ltda.
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
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
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cristália Produtos Químicos Farmacêuticos Ltda.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

August 13, 2009

First Submitted That Met QC Criteria

August 13, 2009

First Posted (Estimate)

August 14, 2009

Study Record Updates

Last Update Posted (Estimate)

July 16, 2015

Last Update Submitted That Met QC Criteria

July 15, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRT059

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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