Overview

Fentanyl Matrix in Lung Cancer Pain

Status:
Completed
Trial end date:
2007-05-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to evaluate the usefulness of fentanyl matrix by assessing patients' satisfaction when administrating fentanyl matrix, a background pain treatment, and a breakthrough pain treatment to lung cancer patients who complain of pain. Fentanyl matrix is designed to deliver medication at a nearly constant amount per unit time into the body through the skin for 3 days (72 hours).
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Janssen Korea, Ltd., Korea
Treatments:
Fentanyl
Criteria
Inclusion Criteria:

- Patients with histologically confirmed lung cancer, who complain of cancer pain

- Patients who are taking Ultracet, Tramadol, or Codeine (or Codeine combination drug)
for cancer pain-relief purposes, but still complain of a pain level of 4 or above on
the Numeric Rating Scale (NRS) during the past 24 hours: Ultracet 3 tablets/day,
Tramadol 150 mg/day, Codeine 200 mg /day, or Codeine combination less than 3
capsules/day

- Patients who are able to communicate with the investigator about his/her pain

- Patients who use proper contraceptives during the study period if they are women of
childbearing potential

- Patients whose life expectancy is 3 months or longer

- Patients who have signed an informed consent form

Exclusion Criteria:

- Patients participating in other clinical trials

- Patients with a history of hypersensitivity to opioid analgesics

- Patients with a history of drug abuse

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

- Patient with a history of CO2 retention (e.g. chronic obstructive pulmonary disease)

- Patients who are receiving radiotherapy or chemotherapy when registering for the study
or who plan to receive it during the study

- Patient who are pregnant or are of childbearing potential and not using contraceptives