An Efficacy and Safety Study of Transdermal Therapeutic System (TTS)-Fentanyl in Cancer Participants With Inadequately Controlled Pain by Non-Narcotic Analgesics

Overview

The purpose of this study is to evaluate the efficacy and safety of Transdermal Therapeutic System (TTS)-fentanyl D-Trans (transdermal patch containing a drug that is put on the skin so the drug will enter the body through the skin) treatment in cancer participants of Korea with inadequately controlled pain by non-narcotic analgesics (drug used to control pain) and participant's satisfaction.

Full Title of Study: “Use of Durogesic D-TRANS in Cancer Pain Patients With Inadequately Controlled Pain Relief From Weak Opioids”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 2009

Detailed Description

This is an open-label (all people know the identity of the intervention), single-arm, multicenter (conducted in more than one hospital or medical school team work on a medical research study), prospective (study following participants forward in time) study conducted to assess the efficacy and safety of TTS-fentanyl D-trans in cancer participants of Korea with inadequately controlled pain by non-narcotic analgesics and for participant's satisfaction. The participants will receive the initial dose of TTS-fentanyl D-trans patch releasing 12 micrograms per hour (12 mcg/hr) of fentanyl and will be increased by 12 mcg/hr or 25 mcg/hr, every 3 days depending on the participant's pain control. Efficacy will primarily be evaluated by participant's satisfaction with pain treatment. Participant's safety will be monitored throughout the study.

Interventions

  • Drug: Fentanyl D-trans
    • Fentanyl D-trans will be applied as transdermal patch releasing drug at the rate of 12.5 microgram per hour (mcg/hr) for 3 days with a dose ranging from 12 mcg/hr to 50 mcg/hr.

Arms, Groups and Cohorts

  • Experimental: Transdermal Therapeutic System (TTS)-Fentanyl D-trans

Clinical Trial Outcome Measures

Primary Measures

  • Percentage of Participants Satisfied With Pain Treatment
    • Time Frame: Day 29
    • Participants were assessed for their satisfaction for pain treatment after the application of the Transdermal Therapeutic System (TTS)-fentanyl D-trans.

Secondary Measures

  • Difference in Pain Intensity Before and After Administration of (TTS)-Fentanyl D-trans
    • Time Frame: Day 1 and Day 29
    • Pain intensity difference was measured by Visual Analog Scale (VAS) score, which ranges from 0 to 10 centimeter (cm) where 0 cm=no pain and 10 cm= unimaginably severe pain.

Participating in This Clinical Trial

Inclusion Criteria

  • Participants who complains of cancer pain – Participants who have taken non-opioid analgesics for the past one month for cancer pain relief purpose, but still have average 4 or higher pain level on the Visual Analogue Scale (VAS) for the last 24 hours – Participants with an estimated life expectancy of at least 2 months – Participants who are able to communicate with the investigator – Participants who can avoid getting pregnant appropriately if there is a possibility of pregnancy during this study period Exclusion Criteria:

  • Participants participating in another clinical trial – Participants with a history of oversensitive reaction to a narcotic analgesic or with an existing history of drug abuse – Participants who have active skin disease, avoiding application of the transdermal system – Participants with a history of CO2 (carbon di-oxide) retention (i.e. chronic obstructive pulmonary disease) – Participants undergoing chemotherapy/radiotherapy right now or is going to get chemotherapy/radiotherapy within the study period

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Janssen Korea, Ltd., Korea
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Janssen Korea, Ltd., Korea Clinical Trial, Study Director, Janssen Korea, Ltd., Korea

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