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

Information source: Janssen Korea, Ltd., Korea
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pain; Cancer

Intervention: Fentanyl D-trans (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Janssen Korea, Ltd., Korea

Official(s) and/or principal investigator(s):
Janssen Korea, Ltd., Korea Clinical Trial, Study Director, Affiliation: Janssen Korea, Ltd., Korea


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.

Clinical Details

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

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Percentage of Participants Satisfied With Pain Treatment

Secondary outcome: Difference in Pain Intensity Before and After Administration of (TTS)-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.


Minimum age: 20 Years. Maximum age: N/A. Gender(s): Both.


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


- 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

Locations and Contacts

Additional Information

Starting date: April 2007
Last updated: April 10, 2014

Page last updated: August 23, 2015

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