Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ITP FIRTECH · 1 trial · 1 indication
NRS is used to assess pain intensity, it is a 11-point scale (0-10) where '0' representing 'no pain' and '10' representing 'worst pain imaginable'. Responder is defined as participant with ≥30% decrease from baseline in pain NRS and who did not take rescue medication (defined as receiving paracetamol (authorized), any other analgesics and anti-inflammatory drugs as well as any non-pharmaceutical therapy (prohibited) for treating pain starting from randomization to Day 5 or starting before the study and still ongoing at randomization).
| Arm | Type | Description |
|---|---|---|
| ITP FIRTECH | EXPERIMENTAL | The ITP FIRTECH patch was applied on the lower back region of the body on Day 1 and intended to be worn for 5 Days (Day 5). |
| No Patch Control Arm | NO_INTERVENTION | No patch application. |
| Name | Type | Description |
|---|---|---|
| ITP FIRTECH | DEVICE | Infrared Therapy Patch |
Inclusion Criteria: * Participants suffering from mild to moderate acute low back pain * Low back pain (lumbar back pain) is defined as pain in the back from the level of the lowest rib down to the gluteal fold * Acute episode is defined as acute pain with less than 1 month duration * With intensit...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Hinge Health, Inc. Class A | HNGE | 1 | N/A | Undisclosed |
| Stryker Corporation | SYK | 1 | - | Undisclosed |
| Boston Scientific Corporation | BSX | 1 | N/A | Undisclosed |
| Aclarion, Inc. | ACON | 1 | - | Undisclosed |
| United Therapeutics Corporation | UTHR | 1 | N/A | Undisclosed |
| eHealth, Inc. | EHTH | 1 | N/A | Undisclosed |
ITP FIRTECH is an investigational drug being studied for the treatment of mild to moderate acute low back pain. It is currently in Phase 3 clinical development and has not been approved by regulatory authorities.
ITP FIRTECH is being developed by Sanofi, a multinational pharmaceutical company listed on the stock exchange under the ticker symbol SNY.
ITP FIRTECH is in Phase 3 clinical development. It is an investigational drug and has not yet been approved for use. A Phase 3 trial has been completed to evaluate its efficacy and safety in patients with low back pain.
ITP FIRTECH has one completed Phase 3 clinical trial registered as NCT05137041, titled 'Efficacy and Safety of FIRTECH in Patients With Mild to Moderate Acute Low Back Pain.' The trial enrolled 221 participants in Germany and Italy and was not double-blinded.
Yes, ITP FIRTECH is also known as FIRTECH. The clinical trial NCT05137041 refers to the drug as FIRTECH, and both names refer to the same investigational product being developed by Sanofi for low back pain.