Status:
WITHDRAWN
Efficacy and Safety Study of Fentanyl Transdermal (Fentanest®)
Lead Sponsor:
Cristália Produtos Químicos Farmacêuticos Ltda.
Conditions:
Pain
Palliative Care
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00959400
Start Date
November 1 2009
Last Update
July 16 2015
Active Locations (5)
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1
Hospital Universitario da Universidade Federal do Maranhao
São Luís, Maranhão, Brazil, 65020-070
2
Instituto Nacional de Cancer - Hospital do Cancer I
Rio de Janeiro, Rio de Janeiro, Brazil, 20230-130
3
Hospital das Clinicas da Faculdade de Medicina da Universidade Estadual Paulista "Julio de Mesquita Filho" - Campus de Botucatu - Unesp
Botucatu, São Paulo, Brazil, 18618-970
4
Hospital A. C. Camargo
São Paulo, São Paulo, Brazil, 01509-010