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An Efficacy and Safety Study of Low-dose Transdermal Therapeutic System (TTS)-Fentanyl D-Trans in Taiwan Participants With Cancer Pain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen-Cilag Ltd.
ClinicalTrials.gov Identifier:
NCT00771199
First received: October 10, 2008
Last updated: September 16, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Cancer, Pain
Drug: Transdermal Therapeutic System (TTS)-Fentanyl
Phase 4

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Janssen-Cilag Ltd.:

Primary Outcome Measures:
  • 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 Percentage of participants who will be prematurely withdrawn from the study due to any adverse events will be reported.


Secondary Outcome Measures:
  • 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.


Enrollment: 14
Study Start Date: October 2008
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00771199

Sponsors and Collaborators
Janssen-Cilag Ltd.
Investigators
Study Director: Janssen-Cilag Ltd Clinical Trial Janssen-Cilag Ltd.
  More Information

No publications provided

Responsible Party: Janssen-Cilag Ltd.
ClinicalTrials.gov Identifier: NCT00771199     History of Changes
Other Study ID Numbers: CR014602, FENPAI4054
Study First Received: October 10, 2008
Last Updated: September 16, 2014
Health Authority: Taiwan: Department of Health

Keywords provided by Janssen-Cilag Ltd.:
Cancer pain
Pain
Fentanyl
Durogesic
Cancer
Transdermal

Additional relevant MeSH terms:
Fentanyl
Adjuvants, Anesthesia
Analgesics
Analgesics, Opioid
Anesthetics
Anesthetics, General
Anesthetics, Intravenous
Central Nervous System Agents
Central Nervous System Depressants
Narcotics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014