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

NCT00771199 | Completed Phase 4

• 2 other identifiers: CR014602FENPAI4054
• Study Type: interventional
• Target: 14
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cancer, Pain

Keywords

Cancer pain; Pain; Fentanyl; Durogesic; Cancer; Transdermal

Outcome Measures

Primary Outcomes (1)

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 Percentage of participants who will be prematurely withdrawn from the study due to any adverse events will be reported.

  Day 0 up to Day 28

Secondary Outcomes (5)

• Brief Pain Inventory (BPI) Score (Question 6)

  Day 0, Day 7, Day 14 and Day 28

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

  Day 0, Day 7, Day 14 and Day 28

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

  Day 0 up to Day 28

• Investigator's Global Assessment Scale Score

  Day 0 and Day 28

• Percentage of Participants With Treatment Satisfaction

  Day 0 and Day 28

Study Arms (1)

Transdermal Therapeutic System (TTS)-Fentanyl

EXPERIMENTAL

Drug: Transdermal Therapeutic System (TTS)-Fentanyl

Interventions

Transdermal Therapeutic System (TTS)-Fentanyl DRUG

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.

Transdermal Therapeutic System (TTS)-Fentanyl

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen-Cilag Ltd.: lead

MeSH Terms

Conditions

Cancer Pain; Pain; Neoplasms

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Janssen-Cilag Ltd Clinical Trial

  Janssen-Cilag Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2008
• First Posted: October 13, 2008
• Study Start: October 1, 2008
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: September 17, 2014

Record last verified: 2014-09