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

Janssen (J&J Innovative Medicine)

Status and phase

Completed

Phase 4

Conditions

Pain; Cancer

Treatments

Drug: Fentanyl D-trans

Study type

Interventional

Funder types

Industry

Identifiers

NCT01060124

CR012256

FEN-KOR-13

Details and patient eligibility

About

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 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.

Enrollment

103 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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