Efficacy and Safety Study of Fentanyl Transdermal (Fentanest®)

Pain Clinical Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00959400
• Other study ID #: CRT059
• Status: Withdrawn
• Phase: Phase 3
• First received: August 13, 2009
• Last updated: July 15, 2015
• Start date: November 2009

Study information

• Verified date: July 2015
• Source: Cristália Produtos Químicos Farmacêuticos Ltda.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics CommitteeBrazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain
• Palliative Care

Intervention

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.

Locations

Country	Name	City	State
Brazil	Hospital das Clinicas da Faculdade de Medicina da Universidade Estadual Paulista "Julio de Mesquita Filho" - Campus de Botucatu - Unesp	Botucatu	Sao Paulo
Brazil	Instituto Nacional de Cancer - Hospital do Cancer I	Rio de Janeiro
Brazil	Hospital Universitario da Universidade Federal do Maranhao	Sao Luis	Maranhao
Brazil	Hospital A. C. Camargo	Sao Paulo
Brazil	Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo - HCFMUSP	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Cristália Produtos Químicos Farmacêuticos Ltda.

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary: formulation tolerability (assessed by adverse events incidence). Co primary: formulation analgesic efficacy (assessed by rescue medication demand).		4 weeks folow-up	Yes
Secondary	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	Yes