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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

Information source: Janssen-Cilag Ltd.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cancer, Pain

Intervention: Transdermal Therapeutic System (TTS)-Fentanyl (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Janssen-Cilag Ltd.

Official(s) and/or principal investigator(s):
Janssen-Cilag Ltd Clinical Trial, Study Director, Affiliation: Janssen-Cilag Ltd.

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.

Clinical Details

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 design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Percentage of Participants Dropped From Study due to Adverse Events

Secondary outcome:

Brief Pain Inventory (BPI) Score (Question 6)

BPI Score (Question 9) - Quality of Life (QOL)

Average Daily Dose and Final Dose of Transdermal Therapeutic System (TTS)-fentanyl

Investigator's Global Assessment Scale Score

Percentage of Participants With Treatment Satisfaction

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Additional Information

Starting date: October 2008
Last updated: September 16, 2014

Page last updated: August 23, 2015

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