Trials / Completed
CompletedNCT05137041
Efficacy and Safety of FIRTECH in Patients With Mild to Moderate Acute Low Back Pain
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 221 (actual)
- Sponsor
- Sanofi · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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
Detailed description
Duration of study participation is up to 6 days per participant.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | ITP FIRTECH | Infrared Therapy Patch |
Timeline
- Start date
- 2021-11-04
- Primary completion
- 2022-11-22
- Completion
- 2022-11-22
- First posted
- 2021-11-30
- Last updated
- 2025-09-09
- Results posted
- 2024-09-19
Locations
7 sites across 2 countries: Germany, Italy
Source: ClinicalTrials.gov record NCT05137041. Inclusion in this directory is not an endorsement.