At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 45 enrolled
Drug / intervention
TTS-fentanyldrug
Likely dose
TTS-fentanyl 12.5 microgramfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Evaluation Study of Efficacy and Safety of TTS-Fentanyl in Severe Chronic Low Back Pain
In Brief
A Phase 4 clinical trial evaluating TTS-fentanyl for Low Back Pain. Completed, enrolled 45 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLow Back Pain
CountriesThailand
Collaborators--
Timeline
Phase 4CompletedFinished
2009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartAug 2008
Primary CompletionJun 2009
First PostedJan 2013
TodayJul 2026
First PostedJan 24, 2013
Enrollment StartAug 1, 2008
Primary CompletionJun 1, 2009
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 13.4 years ago
Interventions
TTS-fentanyldrug
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.