Clinical trial NCT00771199: An Efficacy and Safety Study of Low-dose Transdermal Therapeutic System (TTS)-Fentanyl D-Trans in Taiwan Participants With Cancer Pain
Official title: An Open-label, Multicenter Study to Evaluate the Safety/Tolerability and Clinical Utility of Low-dose TTS-Fentanyl D-TRANS in Taiwan Patients With Cancer Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cancer, Pain
Keywords: Cancer pain
Pain
Fentanyl
Durogesic
Cancer
Transdermal
Lead sponsor: Janssen-Cilag Ltd.
Sponsor class: INDUSTRY
First posted: 2008-10-13
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate safety/tolerability and clinical utility of low-dose transdermal therapeutic system (TTS \[medicated adhesive pad that is placed on the skin to deliver a timed-release dose of medication through the skin into the bloodstream\]) - fentanyl in Taiwan participants with cancer pain. Secondly, to demonstrate the dropout rate that will be decreased by initiating therapy with12 microgram per hour (mcg/hr) instead of with 25 mcg/h.

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 study to evaluate the efficacy and safety of low-dose TTS-fentanyl in Taiwan participants with cancer pain. Eligible participants will be enrolled and scheduled to return at Day 0, 7, 14 and 28. Participants will receive TTS-fentanyl for 28 days at a starting dose of 12 micrograms per hour (mcg/h) (one patch). Dose of fentanyl can increased or decreased as per Investigator's discretion to maintain participant's pain score at 2 or less on the Brief Pain Inventory (BPI) question 6 (that tells how much pain you have right now). Safety will primarily be evaluated by measuring participant's dropout rate due to adverse events. Participants' safety will be monitored throughout the study.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Percentage of Participants Dropped From Study due to Adverse Events
timeFrame: Day 0 up to Day 28
Secondary outcomes:
measure: Brief Pain Inventory (BPI) Score (Question 6)
timeFrame: Day 0, Day 7, Day 14 and Day 28
measure: BPI Score (Question 9) - Quality of Life (QOL)
timeFrame: Day 0, Day 7, Day 14 and Day 28
measure: Average Daily Dose and Final Dose of Transdermal Therapeutic System (TTS)-fentanyl
timeFrame: Day 0 up to Day 28
measure: Investigator's Global Assessment Scale Score
timeFrame: Day 0 and Day 28
measure: Percentage of Participants With Treatment Satisfaction
timeFrame: Day 0 and Day 28
Other outcomes:
Locations:
Study officials:
affiliation: Janssen-Cilag Ltd.
name: Janssen-Cilag Ltd Clinical Trial
role: STUDY_DIRECTOR
References: