Fentanyl Matrix in Lung Cancer Pain

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

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).

Study Overview

• Status: Completed
• Conditions: Pain; Lung Cancer
• Intervention / Treatment: Drug: fentanyl matrix

Detailed 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

• Study Type: Interventional
• Enrollment (Actual): 268
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 001; fentanyl matrix Fentanyl transdermal patch 12 - 25mcg/hr can increase with 12 - 25mcg/h based on pain assessment	Drug: fentanyl matrix; Fentanyl transdermal patch 12 - 25mcg/hr

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Patient's satisfaction with pain treatment as measured by 5-point verbal scale	Day 1, 8 and 22

Secondary Outcome Measures

Outcome Measure	Time Frame
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)
Detailed reasons for patient's satisfaction with the pain treatment	Day 22 (visit 3)
Patient's and investigator's satisfaction measured by 5-point verbal scale with the study drug	Day 22 (visit 3)
Dose of fentanyl matrix	Day 1 (visit 1), 8 (visit 2) and 22 (visit 3)

Collaborators and Investigators

• Sponsor: Janssen Korea, Ltd., Korea

Study record dates

Study Major Dates

• Study Start: May 1, 2006
• Primary Completion (Actual): May 1, 2007
• Study Completion (Actual): May 1, 2007

Study Registration Dates

• First Submitted: January 29, 2010
• First Submitted That Met QC Criteria: January 29, 2010
• First Posted (Estimate): February 2, 2010

Study Record Updates

• Last Update Posted (Estimate): February 5, 2010
• Last Update Submitted That Met QC Criteria: February 4, 2010
• Last Verified: February 1, 2010

More Information

Terms related to this study

• Keywords: fentanyl matrix
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Fentanyl
• Other Study ID Numbers: CR012259