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

Use of Durogesic D-TRANS in Cancer Pain Patients With Inadequately Controlled Pain Relief From Weak Opioids

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.

Study Overview

• Status: Completed
• Conditions: Pain; Cancer
• Intervention / Treatment: Drug: Fentanyl D-trans

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.

• Study Type: Interventional
• Enrollment (Actual): 103
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Transdermal Therapeutic System (TTS)-Fentanyl D-trans	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.; Other Names: Durogesic D-Trans

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in Pain Intensity Before and After Administration of (TTS)-Fentanyl D-trans	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.	Day 1 and Day 29

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Detailed Reason for Satisfaction With the Pain Treatment	Participants were assessed for satisfaction for pain treatment after the administration of the TTS-fentanyl D-trans in detail with satisfied reasons, which are excellent pain relieving effect, convenient administration, minor adverse event, generally satisfied and other.	Day 29
Initial and End Point Dose of TTS-Fentanyl D-trans	Dose of TTS-fentanyl D-trans were monitored at start and end of the trial.	Day 1 and Day 29
Number of Participants With Investigator's Overall Evaluation on the Pain Treatment	Investigator assessed the participants for satisfaction on pain treatment after the administration of the TTS-fentanyl D-trans as very satisfied, satisfied, average, dissatisfied or very dissatisfied.	Day 29

Collaborators and Investigators

• Sponsor: Janssen Korea, Ltd., Korea

Study record dates

Study Major Dates

• Study Start: April 1, 2007
• Primary Completion (ACTUAL): February 1, 2009
• Study Completion (ACTUAL): February 1, 2009

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): April 29, 2014
• Last Update Submitted That Met QC Criteria: April 10, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: Pain; Cancer; TTS-Fentanyl D-trans; Durogesic D-trans
• Additional Relevant MeSH Terms: 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: CR012256; FEN-KOR-13