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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

NCT00771199 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2014-09-17

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Janssen-Cilag Ltd.

    lead INDUSTRY

Principal Investigators

  • Janssen-Cilag Ltd Clinical Trial · Janssen-Cilag Ltd.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2008-11-30
Completion
2008-11-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00771199 on ClinicalTrials.gov