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High-dose Fentanyl Matrix Application for Cancer Pain: Multicenter, Prospective, Observational Study


Phase 4
20 Years
N/A
Not Enrolling
Both
Pain

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Trial Information

High-dose Fentanyl Matrix Application for Cancer Pain: Multicenter, Prospective, Observational Study


This is a multi-center, open-label (all people know the identity of the intervention),
prospective (the patients are identified and then followed forward in time for the outcome
of the study) observational study. The study population comprises patients who are admitted
to a study center during the study period and are receiving a strong oral long-acting opioid
analgesic but deemed to control pain insufficiently. Since this study is an observational
study conducted in real practice, a dose of fentanyl matrix should be adjusted depending on
an individual patient's response at the investigator's discretion. However, for the patients
whose pain is not sufficiently controlled despite administration of strong long-acting
opioid analgesics, the minimum initial dose will be fentanyl matrix 75 micrograms/h and the
investigator can adjust dosage according to the degree of the patients' pain control during
the 9 days of the study period.


Inclusion Criteria:



- Patients complaining of cancer pain which requires administration of long-acting
opioid analgesics

- Patients whose pain is not sufficiently controlled despite administration of strong
long-acting opioid analgesics

- Patients who are deemed to need an initial minimum dose of fentanyl matrix 75
micrograms/h

- Patients who signed the informed consent form

Exclusion Criteria:

- Patients with a history of or current drug or alcohol abuse

- Childbearing women who are pregnant or likely to be pregnant during the study period
and men who are neither infertile nor willing to refrain from sexual relations but
whose partner does not conduct an effective contraception

- Patients who are unable to use a transdermal system due to skin disease

- Patients with history of hypersensitivity to opioid analgesics

- Patients who are not eligible for the study participation based on warnings,
precautions and contraindications in the package insert of the study drug at the
investigator's discretion

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

The percentage of patients who are very satisfied or satisfied with the pain treatment after the study drug administration

Outcome Description:

The overall satisfaction is measured by a 5-point scale. Patients' answers are rated as: "very satisfied", "satisfied", "fair", "dissatisfied", or "very dissatisfied".

Outcome Time Frame:

Day 10

Safety Issue:

No

Principal Investigator

Janssen Korea, Ltd., Korea Clinical Trial

Investigator Role:

Study Director

Investigator Affiliation:

Janssen Korea, Ltd., Korea

Authority:

Korea: Food and Drug Administration

Study ID:

CR015778

NCT ID:

NCT01816503

Start Date:

December 2008

Completion Date:

July 2009

Related Keywords:

  • Pain
  • Pain
  • Cancer pain
  • Fentanyl
  • Fentanyl matrix
  • Opioid analgesic

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