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

Phase 4

Completed

• Conditions: Pain; Cancer
• Interventions: Drug: Fentanyl D-trans

• Registration Number: NCT01060124
• Lead Sponsor: Janssen Korea, Ltd., Korea

Brief Summary

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.

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 Timeline

• Study Start: 2007-04
• Primary Completion: 2009-02
• Study Completion: 2009-02
• Study First Submitted: 2010-01-29
• Study First Submitted QC: 2010-01-29
• Study First Posted: 2010-02-02
• Results First Submitted: 2013-03-14
• Results First Submitted QC: 2013-03-14
• Results First Posted: 2013-04-26
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-10
• Last Update Posted: 2014-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 103

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Transdermal Therapeutic System (TTS)-Fentanyl D-trans	Fentanyl D-trans	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Difference in Pain Intensity Before and After Administration of (TTS)-Fentanyl D-trans	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.