Efficacy and Safety Study of Fentanyl Transdermal (Fentanest®)

NCT00959400 | Withdrawn Phase 3

• 1 other identifier: CRT059
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 5

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

Keywords

Fentanyl Transdermal; Pain; Cancer

Outcome Measures

Primary Outcomes (1)

• Primary: formulation tolerability (assessed by adverse events incidence). Co primary: formulation analgesic efficacy (assessed by rescue medication demand).

  4 weeks folow-up

Secondary Outcomes (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).

  3 months

Study Arms (1)

Fentanyl Transdermal

EXPERIMENTAL

Drug: Fentanyl Transdermal

Interventions

Fentanyl Transdermal 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.

Fentanyl Transdermal

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Cristália Produtos Químicos Farmacêuticos Ltda.: lead

Study Sites (5)

Hospital Universitario da Universidade Federal do Maranhao

São Luís, Maranhão, 65020-070, Brazil

Location

Instituto Nacional de Cancer - Hospital do Cancer I

Rio de Janeiro, Rio de Janeiro, 20230-130, Brazil

Location

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

Botucatu, São Paulo, 18618-970, Brazil

Location

Hospital A. C. Camargo

São Paulo, São Paulo, 01509-010, Brazil

Location

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

São Paulo, São Paulo, 05403-000, Brazil

Location

MeSH Terms

Conditions

Pain; Neoplasms

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 13, 2009
• First Posted: August 14, 2009
• Study Start: November 1, 2009
• Primary Completion: June 1, 2011
• Last Updated: July 16, 2015

Record last verified: 2015-07

Locations

BR (5)