Fentanyl Matrix in Lung Cancer Pain

Pain Clinical Trial

Official title:

Evaluation of the Usefulness of DurogesicD-TRANS for Pain Treatment in Lung Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01060137
• Other study ID #: CR012259
• Status: Completed
• Phase: Phase 4
• First received: January 29, 2010
• Last updated: February 4, 2010
• Start date: May 2006
• Est. completion date: May 2007

Study information

• Verified date: February 2010
• Source: Janssen Korea, Ltd., Korea
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Description:

This study is open-label, single-arm, multicenter, prospective study to evaluate the usefulness of fentanyl matrix (fentanyl transdermal patch-type system) by assessing patient satisfaction when administrating fentanyl matrix (a background pain treatment, and a breakthrough pain treatment) for patients with lung cancer for 21 days. Fentanyl transdermal patch-type system is designed to deliver medication at a nearly constant amount per unit time into the body through the skin for 3 days (72 hours). Studies about transdermal fentanyl have found that it had analgesic effects on malignant pain, and most patients receiving the medication preferred fentanyl because they experienced less constipation. Safety assessments will include adverse event monitoring, vital signs, laboratory work. starting with 12.5g/h or 25g/h of fentanyl matrix transdermally at the investigator's discretion and flexible dose depending the patient's pain relief for 3 weeks

Recruitment information / eligibility

• Status: Completed
• Enrollment: 268
• Est. completion date: May 2007
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms
• Pain

Intervention

Drug:
• fentanyl matrix
Fentanyl transdermal patch 12 - 25mcg/hr

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Korea, Ltd., Korea

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient's satisfaction with pain treatment as measured by 5-point verbal scale		Day 1, 8 and 22	No
Secondary	Difference in pain intensity measured by Numeric Rating Scale before and after treatment of the study drug measured		Day 1 (visit 1) and 22 (visit 3)	No
Secondary	Detailed reasons for patient's satisfaction with the pain treatment		Day 22 (visit 3)	No
Secondary	Patient's and investigator's satisfaction measured by 5-point verbal scale with the study drug		Day 22 (visit 3)	No
Secondary	Dose of fentanyl matrix		Day 1 (visit 1), 8 (visit 2) and 22 (visit 3)	No