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Phase 3
18 Years
70 Years
Not Enrolling
Pain, Palliative Care

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Trial Information

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.

Type of Study:


Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

4 weeks folow-up

Safety Issue:



Brazil: Ethics Committee

Study ID:




Start Date:

November 2009

Completion Date:

Related Keywords:

  • Pain
  • Palliative Care
  • Fentanyl Transdermal
  • Pain
  • Cancer