An Efficacy and Safety Study of Low-dose Transdermal Therapeutic System (TTS)-Fentanyl D-Trans in Taiwan Participants With Cancer Pain
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.
Drug: Transdermal Therapeutic System (TTS)-Fentanyl
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Percentage of Participants Dropped From Study due to Adverse Events [ Time Frame: Day 0 up to Day 28 ] [ Designated as safety issue: Yes ]An adverse event is any untoward medical occurrence in a clinical study participant administered a pharmaceutical product. An adverse event does not necessarily have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. Percentage of participants who will be prematurely withdrawn from the study due to any adverse events will be reported.
- Brief Pain Inventory (BPI) Score (Question 6) [ Time Frame: Day 0, Day 7, Day 14 and Day 28 ] [ Designated as safety issue: No ]The BPI question number 6 describes pain severity, will be measured by the daily pain diary on numeric rating scale (NRS), ranging from 1 to 10; where 0 signifies no pain and 10 signifies extreme pain.
- BPI Score (Question 9) - Quality of Life (QOL) [ Time Frame: Day 0, Day 7, Day 14 and Day 28 ] [ Designated as safety issue: No ]Participant's quality of life (QOL) will be assessed by BPI question number 9 (items 9a to 9g), which describes "how during the past 24 hours pain has interfered with participants general activity, mood, walking ability, normal work, relation with other people, sleep, enjoyment of life". Each item will be measured on NRS, ranges from 1 to 10 where 0 signifies does not interfere and 10 signifies completely interferes. Total score is the average of scores of all items and ranges from 0 to 10, where higher scores signifies higher pain/interference.
- Average Daily Dose and Final Dose of Transdermal Therapeutic System (TTS)-fentanyl [ Time Frame: Day 0 up to Day 28 ] [ Designated as safety issue: No ]The TTS-fentanyl dosage is only increased in consultation with the treating physician and according to the participant's analgesic requirements, with the intention of maintaining his/ her pain score at 2 or less on the BPI question 6.
- Investigator's Global Assessment Scale Score [ Time Frame: Day 0 and Day 28 ] [ Designated as safety issue: No ]Investigator will complete a global assessment of the participants treatment with respect to pain control using 4-point scale, where 1 signifies poor, 2 signifies fair, 3 signifies good, 4 signifies very good.
- Percentage of Participants With Treatment Satisfaction [ Time Frame: Day 0 and Day 28 ] [ Designated as safety issue: No ]Participants will rate their assessment of treatment satisfaction, using 4-point scale where 1 signifies poor, 2 signifies fair, 3 signifies good and 4 signifies very good.
|Study Start Date:||October 2008|
|Study Completion Date:||November 2008|
|Primary Completion Date:||November 2008 (Final data collection date for primary outcome measure)|
|Experimental: Transdermal Therapeutic System (TTS)-Fentanyl||
Drug: Transdermal Therapeutic System (TTS)-Fentanyl
Participants will receive 1 transdermal patch of TTS-fentanyl containing 12 micrograms per hour (mcg/h) for 28 days. Dose can be increased or decreased as per Investigator's discretion up to 100 mcg/h.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00771199
|Study Director:||Janssen-Cilag Ltd Clinical Trial||Janssen-Cilag Ltd.|