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

Phase 4
20 Years
Not Enrolling
Pain; Cancer

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Trial Information

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

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.

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

Type of Study:


Study Design:

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

Outcome Measure:

Percentage of Participants Satisfied With Pain Treatment

Outcome Description:

Participants were assessed for their satisfaction for pain treatment after the application of the Transdermal Therapeutic System (TTS)-fentanyl D-trans.

Outcome Time Frame:

Day 29

Safety Issue:


Principal Investigator

Janssen Korea, Ltd., Korea Clinical Trial

Investigator Role:

Study Director

Investigator Affiliation:

Janssen Korea, Ltd., Korea


Korea: Food and Drug Administration

Study ID:




Start Date:

April 2007

Completion Date:

February 2009

Related Keywords:

  • Pain; Cancer
  • Pain; Cancer
  • TTS-Fentanyl D-trans
  • Durogesic D-trans