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

• Status: Completed
• Trial end date: 2009-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Korea, Ltd., Korea
• Treatments: Fentanyl

Criteria

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