Status:
COMPLETED
An Efficacy and Safety Study of Low-dose Transdermal Therapeutic System (TTS)-Fentanyl D-Trans in Taiwan Participants With Cancer Pain
Lead Sponsor:
Janssen-Cilag Ltd.
Conditions:
Cancer, Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to evaluate safety/tolerability and clinical utility of low-dose transdermal therapeutic system (TTS \[medicated adhesive pad that is placed on the skin to deliver a timed...
Detailed Description
This is an open-label (all people know the identity of the intervention), multi-center (when more than one hospital or medical school team work on a medical research study), single-arm, non-randomized...
Eligibility Criteria
Inclusion
- Participants diagnosed with cancer; histologically (examination of tissue specimens under a microscope) confirmed malignancy (term for diseases in which abnormal cells divide without control and can invade nearby tissues)
- Participants who are able to communicate effectively with study personnel
- Participants who have intolerable cancer pain (pain score greater than or equal to \[\>=\] 4)
- Participants who have an estimated life expectancy of at least 30 days
- Participants who have given written dated informed consent to participate in the study
Exclusion
- Participants who have already received regular treatment with an strong opioid (morphine-like synthetic narcotic that produces the same effects as drugs derived from the opium poppy \[opiates\]), for their pain before entering the study
- Participants who have already received tramadol (a narcotic-like pain reliever used to treat moderate to severe pain) treatment over 200 milligram (mg) for their pain before entering the study
- Participants with significant abnormalities in hepatic or renal function which would, in the opinion of the Investigator, prevent the participants involvement in the study
- Participants with significant clinical abnormalities in central nervous system (CNS), respiratory or cardiovascular function, which in the investigators judgment prevents participation in the study
- Pregnant or lactating females or females of child bearing potential not currently practicing documented, adequate contraception
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00771199
Start Date
October 1 2008
End Date
November 1 2008
Last Update
September 17 2014
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.