Efficacy and Safety Study of Fentanyl Transdermal (Fentanest®)

Cristalia

Status and phase

Withdrawn

Phase 3

Conditions

Pain

Palliative Care

Treatments

Drug: Fentanyl Transdermal

Study type

Interventional

Funder types

Industry

Identifiers

NCT00959400

CRT059

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.