Back to resultsAn Efficacy and Safety Study of Low-dose Transdermal Therapeutic System (TTS)-Fentanyl D-Trans in Taiwan Participants With Cancer Pain
Primary Purpose
Cancer, Pain
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Transdermal Therapeutic System (TTS)-Fentanyl
Sponsored by
About this trial
This is an interventional treatment trial for Cancer, Pain focused on measuring Cancer pain, Pain, Fentanyl, Durogesic, Cancer, Transdermal
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Transdermal Therapeutic System (TTS)-Fentanyl
Arm Description
Outcomes
Primary Outcome Measures
Percentage of Participants Dropped From Study due to Adverse Events
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.
Secondary Outcome Measures
Brief Pain Inventory (BPI) Score (Question 6)
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)
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
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
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
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.
Full Information
NCT ID
NCT00771199
First Posted
October 10, 2008
Last Updated
September 16, 2014
Sponsor
Janssen-Cilag Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT00771199
Brief Title
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
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
November 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen-Cilag Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Pain
Keywords
Cancer pain, Pain, Fentanyl, Durogesic, Cancer, Transdermal
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Transdermal Therapeutic System (TTS)-Fentanyl
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Transdermal Therapeutic System (TTS)-Fentanyl
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of Participants Dropped From Study due to Adverse Events
Description
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.
Time Frame
Day 0 up to Day 28
Secondary Outcome Measure Information:
Title
Brief Pain Inventory (BPI) Score (Question 6)
Description
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.
Time Frame
Day 0, Day 7, Day 14 and Day 28
Title
BPI Score (Question 9) - Quality of Life (QOL)
Description
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.
Time Frame
Day 0, Day 7, Day 14 and Day 28
Title
Average Daily Dose and Final Dose of Transdermal Therapeutic System (TTS)-fentanyl
Description
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.
Time Frame
Day 0 up to Day 28
Title
Investigator's Global Assessment Scale Score
Description
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.
Time Frame
Day 0 and Day 28
Title
Percentage of Participants With Treatment Satisfaction
Description
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.
Time Frame
Day 0 and Day 28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen-Cilag Ltd Clinical Trial
Organizational Affiliation
Janssen-Cilag Ltd.
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
An Efficacy and Safety Study of Low-dose Transdermal Therapeutic System (TTS)-Fentanyl D-Trans in Taiwan Participants With Cancer Pain
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