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Fentanyl Matrix in Lung Cancer Pain

This study has been completed.
Sponsor:
Information provided by:
Janssen Korea, Ltd., Korea
ClinicalTrials.gov Identifier:
NCT01060137
First received: January 29, 2010
Last updated: February 4, 2010
Last verified: February 2010
History of Changes
  Purpose

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).


Condition Intervention Phase
Lung Cancer
Pain
 Drug: fentanyl matrix
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of the Usefulness of DurogesicD-TRANS for Pain Treatment in Lung Cancer Patients

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

Further study details as provided by Janssen Korea, Ltd., Korea:

Primary Outcome Measures:
  • Patient's satisfaction with pain treatment as measured by 5-point verbal scale [ Time Frame: Day 1, 8 and 22 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Difference in pain intensity measured by Numeric Rating Scale before and after treatment of the study drug measured [ Time Frame: Day 1 (visit 1) and 22 (visit 3) ] [ Designated as safety issue: No ]
  • Detailed reasons for patient's satisfaction with the pain treatment [ Time Frame: Day 22 (visit 3) ] [ Designated as safety issue: No ]
  • Patient's and investigator's satisfaction measured by 5-point verbal scale with the study drug [ Time Frame: Day 22 (visit 3) ] [ Designated as safety issue: No ]
  • Dose of fentanyl matrix [ Time Frame: Day 1 (visit 1), 8 (visit 2) and 22 (visit 3) ] [ Designated as safety issue: No ]

Enrollment: 268
Study Start Date: May 2006
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01060137

Sponsors and Collaborators
Janssen Korea, Ltd., Korea
Investigators
Study Director: Janssen Korea, Ltd. Clinical Trial Janssen Korea, Ltd.
  More Information

No publications provided

Responsible Party: R&D Director, Janssen Korea, Ltd., Korea
ClinicalTrials.gov Identifier: NCT01060137     History of Changes
Other Study ID Numbers: CR012259
Study First Received: January 29, 2010
Last Updated: February 4, 2010
Health Authority: Korea: Food and Drug Administration

Keywords provided by Janssen Korea, Ltd., Korea:
fentanyl matrix

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Fentanyl
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
 Pharmacologic Actions
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Opioid

ClinicalTrials.gov processed this record on May 16, 2013