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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

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ClinicalTrials.gov Identifier: NCT00771199
Recruitment Status : Completed
First Posted : October 13, 2008
Last Update Posted : September 17, 2014
Sponsor:
Information provided by (Responsible Party):
Janssen-Cilag Ltd.

Tracking Information
First Submitted Date  ICMJE October 10, 2008
First Posted Date  ICMJE October 13, 2008
Last Update Posted Date September 17, 2014
Study Start Date  ICMJE October 2008
Actual Primary Completion Date November 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 26, 2014)
Percentage of Participants Dropped From Study due to Adverse Events [ Time Frame: Day 0 up to Day 28 ]
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 Percentage of participants who will be prematurely withdrawn from the study due to any adverse events will be reported.
Original Primary Outcome Measures  ICMJE
 (submitted: October 10, 2008)
Dropout rate due to adverse events (AEs) at day 0, 7, 14 and 28.
Change History Complete list of historical versions of study NCT00771199 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 26, 2014)
  • Brief Pain Inventory (BPI) Score (Question 6) [ Time Frame: Day 0, Day 7, Day 14 and Day 28 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 10, 2008)
Clincial Utility and Safety at day 0, 7, 14 and 28.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Efficacy and Safety Study of Low-dose Transdermal Therapeutic System (TTS)-Fentanyl D-Trans in Taiwan Participants With Cancer Pain
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cancer, Pain
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: Transdermal Therapeutic System (TTS)-Fentanyl
Intervention: Drug: Transdermal Therapeutic System (TTS)-Fentanyl
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 13, 2009)
14
Original Estimated Enrollment  ICMJE
 (submitted: October 10, 2008)
600
Actual Study Completion Date  ICMJE November 2008
Actual Primary Completion Date November 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00771199
Other Study ID Numbers  ICMJE CR014602
FENPAI4054 ( Other Identifier: Janssen-Cilag Ltd )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Janssen-Cilag Ltd.
Study Sponsor  ICMJE Janssen-Cilag Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Janssen-Cilag Ltd Clinical Trial Janssen-Cilag Ltd.
PRS Account Janssen-Cilag Ltd.
Verification Date September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP