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

Janssen Korea, Ltd., Korea103 enrolled

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.

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

103

Conditions

Pain; Cancer

Interventions

Fentanyl D-transDRUG

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.

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: Day 29

Secondary Outcomes

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.

Time frame: Day 1 and Day 29

Data from ClinicalTrials.gov

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