A Randomised, Open, Parallel-group, Multi-centre Trial to Investigate Analgesic Efficacy and Safety of Transdermal Fentanyl (FITpatch) Compared to Standard Opioid Treatment in Cancer Pain.
Subjects that have insufficiently treated, cancer-related chronic pain that requires
long-term treatment with an opioid at Step 3 on the WHO Ladder, and with Karnofsky
performance status above 50.
1. Subject informed consent given.
2. Aged between 18 and 75 years, and for female subjects a proven negative pregnancy
test and adequate contraception.
3. No significant skin lesions on relevant surfaces on the body or diffuse skin
4. No impaired respiratory function nor neurological or psychiatric impairment.
5. No known abuse of drug, narcotic or alcohol.
6. Not pregnant or nursing.
7. Not hypersensitive/allergic to fentanyl or morphine.
8. No head injury, primary brain tumor, increased intracranial pressure or impaired
9. Not participating in other clinical trials.
All exclusion criteria must be answered No for a patient to participate in the trial.
1. Does the patient have significant skin lesions on the upper arms/flat surface of the
upper torso or diffuse skin disease (psoriasis or eczema) that preclude application
of fentanyl patches?
2. Does the patient have a known abuse of drug, narcotic or alcohol?
3. Is the patient pregnant or nursing?
4. Has the patient neurological or mental impairment that may compromise data
5. Is the patient hypersensitive/allergic to fentanyl or morphine or any of the
ingredients in the trial medication?
6. Has the patient any major head injury, primary brain tumour, increased intracranial
pressure or impaired consciousness?
7. Does the patient participate in other clinical with other investigational drugs or
investigation al medical devices or has been participating in such a trial for the
past 30 days?