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
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.
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.
Eligibility
Minimum age: 20 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Additional Information
Starting date: April 2007
Last updated: April 10, 2014
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