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An Efficacy and Safety Study of Transdermal Therapeutic System (TTS)-Fentanyl in Severe Chronic Low Back Pain

NCT01774903 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2013-03-25

Study results available
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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 severe (very serious, life threatening) chronic (lasting a long time) low back pain in Thai participants.

Conditions

  • Low Back Pain

Interventions

DRUG

TTS-fentanyl

TTS-fentanyl patches releasing drug at the rate of 12.5 microgram (µg) per hour for 3 days. The patches will be replaced every 3 days until 30 days.

Sponsors & Collaborators

  • Janssen-Cilag Ltd.,Thailand

    lead INDUSTRY

Principal Investigators

  • Janssen-Cilag Ltd.,Thailand Clinical trial · Janssen-Cilag Ltd.,Thailand

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-08-31
Primary Completion
2009-06-30
Completion
2009-06-30

Countries

  • Thailand

Study Locations

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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 NCT01774903 on ClinicalTrials.gov