Clinical trial NCT00959400: Efficacy and Safety Study of Fentanyl Transdermal (Fentanest®)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Pain
Palliative Care
Keywords: Fentanyl Transdermal
Pain
Cancer
Lead sponsor: Cristália Produtos Químicos Farmacêuticos Ltda.
Sponsor class: INDUSTRY
First posted: 2009-08-14
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Primary: formulation tolerability (assessed by adverse events incidence). Co primary: formulation analgesic efficacy (assessed by rescue medication demand).
timeFrame: 4 weeks folow-up
Secondary outcomes:
measure: 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).
timeFrame: 3 months
Other outcomes:
Locations:
city: Sao Luis
country: Brazil
facility: Hospital Universitario da Universidade Federal do Maranhao
state: Maranhao
city: Botucatu
country: Brazil
facility: Hospital das Clinicas da Faculdade de Medicina da Universidade Estadual Paulista "Julio de Mesquita Filho" - Campus de Botucatu - Unesp
state: Sao Paulo
city: Rio de Janeiro
country: Brazil
facility: Instituto Nacional de Cancer - Hospital do Cancer I
city: Sao Paulo
country: Brazil
facility: Hospital A. C. Camargo
city: Sao Paulo
country: Brazil
facility: Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo - HCFMUSP
Study officials:
References: