CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 221 enrolled
Drug / intervention
ITP FIRTECHdevice
Likely dose
Not stated in 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.

Search/NCT05137041
NCT05137041Phase 3Completed
CompareCT.gov

A Phase IIIB Randomized, Open Label, Two Arms and Parallel Group Clinical Trial to Assess the Efficacy and Safety of FIRTECH (Infrared Therapy Patch), for Treating Patients Suffering From Mild to Moderate Acute Low Back Pain

Sanofi·interventional·Posted Nov 30, 2021·Updated Sep 9, 2025

In Brief

A Phase 3 clinical trial evaluating ITP FIRTECH for Low Back Pain. Completed, enrolled 221 participants across 7 sites in 2 countries.

Detailed Summary

Primary Objective: To assess the efficacy of the infrared therapy patch (ITP) FIRTECH for treating participants suffering from mild to moderate acute low back pain. Secondary Objectives: * To assess the efficacy of ITP FIRTECH on participant disability * To assess the efficacy of ITP FIRTECH on the degree of participant mobility * To assess the safety of ITP FIRTECH

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLow Back Pain
CountriesGermany, Italy
Collaborators--

Timeline

Phase 3CompletedFinished
20222023202420252026
First PostedNov 30, 2021
Enrollment StartNov 4, 2021
Primary CompletionNov 22, 2022
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 4.6 years ago

Interventions

ITP FIRTECHdevice

Infrared Therapy Patch