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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.


Phase 2
20 Years
N/A
Not Enrolling
Both
Pain, Intractable

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Trial Information

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 DurotepĀ® 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 DurotepĀ® 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.


Inclusion Criteria:



- Patients with cancer pain receiving any of the following treatments constantly for at
least 3days before the treatment period :(1)Morphine preparations equivalent to less
than 45 mg/day of oral morphine (or less than 30 mg/day of suppositories, or less
than 15 mg/day of injectable preparations), (2)oral oxycodone preparations equivalent
to less than 30 mg/day, (3)Fentanyl citrate injectable solution equivalent to less
than 0.3 mg/day

- Patients with a pain intensity of less than or equal to 34 mm on the 100 mm Visual
Analogue Scale (VAS)

- Patients with an established diagnosis of cancer of any type who have been notified
of the disease

- Patients may be hospitalized during application of the initial transdermal dose of
fentanyl transdermal matrix patch (patients may be ambulatory after the initial patch
has been replaced with the second dose)

Exclusion Criteria:

- Patients with respiratory dysfunction such as chronic pulmonary disease

- Patients with asthma

- Patients with bradyarrhythmia

- Patients with concurrent liver and/or kidney dysfunction according to the latest
laboratory test values within 14 days before the start of the pre-treatment
observation period

- Patients with organic brain disorder such as elevated intracranial pressure,
disturbance of consciousness/coma, or brain tumor

- Patients with any psychoneurologic complication and judged incapable of self
assessment

- Patients with a history of drug dependency or narcotic abuse

- Patients with a history of hypersensitivity to fentanyl or any other opioid analgesic

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Patient's global assessments of pain

Principal Investigator

Janssen Pharmaceutical K.K. Clinical Trial

Investigator Role:

Study Director

Investigator Affiliation:

Janssen Pharmaceutical K.K.

Authority:

Japan: Japan Pharmaceuticals And Medical Devices Evaluation Center

Study ID:

CR004876

NCT ID:

NCT00216658

Start Date:

December 2004

Completion Date:

September 2005

Related Keywords:

  • Pain, Intractable
  • Fentanyl
  • Cancer pain
  • Japanese patients
  • Pain, Intractable

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