Efficacy and Safety of FITpatch Compared to Standard Opioid Treatment in Cancer Pain (FT-015-IN)

Inclusion criteria

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.

• Subject informed consent given.
• Aged between 18 and 75 years, and for female subjects a proven negative pregnancy test and adequate contraception.
• No significant skin lesions on relevant surfaces on the body or diffuse skin diseases.
• No impaired respiratory function nor neurological or psychiatric impairment.
• No known abuse of drug, narcotic or alcohol.
• Not pregnant or nursing.
• Not hypersensitive/allergic to fentanyl or morphine.
• No head injury, primary brain tumor, increased intracranial pressure or impaired consciousness.
• Not participating in other clinical trials.

Exclusion criteria

All exclusion criteria must be answered No for a patient to participate in the trial.

• 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?
• Does the patient have a known abuse of drug, narcotic or alcohol?
• Is the patient pregnant or nursing?
• Has the patient neurological or mental impairment that may compromise data collection?
• Is the patient hypersensitive/allergic to fentanyl or morphine or any of the ingredients in the trial medication?
• Has the patient any major head injury, primary brain tumour, increased intracranial pressure or impaired consciousness?
• 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?