Open Label Study to Confirm Effectiveness, Safety and Pharmacokinetics of Fentanyl Transdermal Matrix Patch, in Japanese Patients With Cancer Pain Who Have Had a Minimum Amount of Morphine Therapy, Such as Equal to Less Than 45 mg/Day of Oral Morphine or Oxycodone Equal to Less Than 30 mg/Day.
Fentanyl transdermal matrix patch is a narcotic analgesic agent. Compared with the existing
reservoir-type Durotep® Patch, it is not liable to leakage of drug solution and does not
contain alcohol, which becomes a cause of skin irritation. Also this new formulation becomes
available of smaller one of 12.5 mcg/hr while the smallest Durotep® Patch is 25 mcg/hr. This
clinical trial was planned to assess effectiveness, safety and pharmacokinetics of fentanyl
transdermal matrix patch at an initial transdermal dose of 12.5 mcg in Japanese cancer
patients with pain receiving morphine preparations equivalent to less than 45 mg/day of oral
morphine (less than 30 mg for suppository, less than 15 mg for injection), oral oxycodone
preparations equivalent to less than 30 mg/day, or fentanyl citrate injectable solution
equivalent to less than 0.3 mg/day. After pre-treatment period for one to three days for
evaluating the eligibility of the patients for the study, patients will use 3 patches for 10
days. Starting from the first day of treatment with 12.5 mcg/hr patch, fentanyl will be
applied to the chest, the upper arm or other appropriate site, which will be replaced with a
new patch every three days (ca. 72 hr). Total treatment duration is ten days, and dose
adjustment can be allowed.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Patient's global assessments of pain
Janssen Pharmaceutical K.K. Clinical Trial
Janssen Pharmaceutical K.K.
Japan: Japan Pharmaceuticals And Medical Devices Evaluation Center