An Efficacy & Safety Study of Transdermal Therapeutic System

Status Completed

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and safety of Transdermal Therapeutic System (TTS)-fentanyl patch (transdermal patch containing a drug that is put on the skin so the drug will enter the body through the skin) in Thai participants with chronic (lasting a long time) non-malignant (non-cancerous) pain.

Clinical Trial Description

This is an open label (all people know the identity of the intervention), single arm study to assess the efficacy and safety of TTS-fentanyl in Thai participants with chronic non-malignant pain (except for headaches or central spinal cord mediated pain). The study will consist of 2 phases: stabilization phase (up to 7 days before starting the treatment) and treatment phase (30 days). The first patch will be applied by Investigator then by participants themselves until 30 days. All participants will start the treatment with patch releasing 25 micrograms per hour (mcg/h) of fentanyl . The patches will be replaced every 3 days. On Day 3, and every 3 days thereafter, the TTS-fentanyl dose can be titrated (slow increase in drug dosage, guided by participant's responses) as per participant's need. The duration of the treatment will be 30 days after first patch application. The dose of TTS-fentanyl can be slowly increased if needed, by 25 mcg/h to achieve adequate pain control. No increase in TTS-fentanyl dose will be performed within the 72-hour dosing interval. Participants will be allowed the use of oral morphine syrup for the duration of TTS-fentanyl treatment to enable appropriate TTS-fentanyl dose titration. Primary efficacy assessment will be pain control rated by participants. Assessment time points will be Day 0 (Baseline), Day 15 and Day 30 (trial end). At the end of study, global preference on efficacy, side effects and overall satisfaction will also be rated by Investigator and participants. Participants' safety will be monitored throughout the study. ;

Study Design

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

Related Conditions & MeSH terms

Chronic Pain

Clinical Trial Details

NCT number	NCT01816243
Study type	Interventional
Source	Janssen-Cilag Ltd.,Thailand
Contact
Status	Completed
Phase	Phase 4
Start date	April 2004
Completion date	March 2008

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

An Efficacy and Safety Study of Transdermal Therapeutic System (TTS)-Fentanyl in Thai Participants With Chronic Non-Malignant Pain

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms