Fentanyl Matrix in Lung Cancer Pain

NCT01060137 | Completed Phase 4

• 1 other identifier: CR012259
• Study Type: interventional
• Target: 268
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Lung Cancer; Pain

Keywords

fentanyl matrix

Outcome Measures

Primary Outcomes (1)

• Patient's satisfaction with pain treatment as measured by 5-point verbal scale

  Day 1, 8 and 22

Secondary Outcomes (4)

• 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)

Study Arms (1)

001

EXPERIMENTAL

fentanyl matrix Fentanyl transdermal patch 12 - 25mcg/hr can increase with 12 - 25mcg/h based on pain assessment

Drug: fentanyl matrix

Interventions

fentanyl matrix DRUG

Fentanyl transdermal patch 12 - 25mcg/hr

001

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Korea, Ltd., Korea: lead

MeSH Terms

Conditions

Lung Neoplasms; Pain

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Janssen Korea, Ltd. Clinical Trial

  Janssen Korea, Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 29, 2010
• First Posted: February 2, 2010
• Study Start: May 1, 2006
• Primary Completion: May 1, 2007
• Study Completion: May 1, 2007
• Last Updated: February 5, 2010

Record last verified: 2010-02