10 completed, 1 terminated. 6 Phase 2, 5 Phase 3, 2 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 6 | Completed 6 |
| Phase 3 | 5 | Completed 4, Terminated 1 |
| Phase 1 | 2 | Completed 2 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Efficacy and Safety of Chloroprocaine 3% Gel and Oxybuprocaine 0.4% Eye Drops Anesthesia in Pediatric Population Chloroprocaine 3% eye gel, Oxybuprocaine Hydrochloride 4 Mg/mL Eye Drops - Local Anesthetic | Phase 3 | Completed | Sintetica SA | 74 | 2024-05-23 | 2026-03-09 |
| Chloroprocaine 3% Gel Eye Drop as Topical Anestheticsin Phacoemulsification. Chloroprocaine 3%, Tetracaine 0.5% - Cataract | Phase 3 | Completed | Sintetica SA | 338 | 2020-09-09 | 2023-01-18 |
| Efficacy, Safety and Tolerability Study of Chloroprocaine 3% Gel Eye Drops in Healthy Volunteers Ocular gel - Healthy Volunteers | Phase 2 / Phase 3 | Completed | Sintetica SA | 96 | 2020-06-29 | 2022-03-17 |
| Efficacy, Safety and Local Tolerability Study of Chloroprocaine 3% Gel Eye Drops in Healthy Volunteers Ocular gel - Healthy Subjects | Phase 1 / Phase 2 | Completed | Sintetica SA | 105 | 2020-06-16 | 2021-09-16 |
| The Efficacy and Safety of Chloroprocaine 1% and 2% in Pediatric Population Chloroprocaine 1% Injectable Solution, Chloroprocaine 2% Injectable Solution - Hernia, Inguinal, Flat Foot | Phase 2 | Completed | Sintetica SA | 164 | 2019-02-14 | 2026-03-23 |
| Intrathecal Paracetamol Before Spinal Anaesthesia With Chloroprocaine HCl 1% for Short Knee Procedures 30 mg Paracetamol 3% (1 mL), 60 mg Paracetamol 3% (2 mL), 90 mg Paracetamol 3% (3 mL) - Pain, Postoperative | Phase 2 | Completed | Sintetica SA | 60 | 2018-08-06 | 2021-06-24 |
| Dose-finding Study of Intrathecal Paracetamol Administered Immediately Before Spinal Anaesthesia Paracetamol 3%, Placebo injection containing Saline solution 0.9%, Hyperbaric Bupivacaine HCl 0.5% - Phase 1: Pain Management, Phase 2: Pain Management | Phase 1 / Phase 2 | Completed | Sintetica SA | 69 | 2016-11-01 | 2021-10-27 |
| Chloroprocaine 3% - Epidural Anesthesia in Unplanned Caesarean Section Chloroprocaine, Ropivacaine - Unplanned Caesarean Section | Phase 3 | Terminated | Sintetica SA | 16 | 2016-10-01 | 2023-11-21 |
| Spinal Anaesthesia With Chloroprocaine HCl 1% for Elective Lower Limb Procedures of Short Duration. Chloroprocaine HCl 1% - Short Duration Lower Limb Surgery Via Spinal Anaesthesia | Phase 2 | Completed | Sintetica SA | 45 | 2015-06-01 | 2021-05-18 |
| Chloroprocaine 2% vs Ropivacaine 0.75% in Ultrasound-guided Axillary Nerve Block Chloroprocaine HCl 2%, Ropivacaine 0.75% - Axillary Nerve Block | Phase 3 | Completed | Sintetica SA | 211 | 2015-04-01 | 2021-07-15 |
| Observational Study on 2-chloroprocaine Hydrochloride 1% 2-chloroprocaine hydrochloride, 1% - Neurological Complication, in Particular TNS or CES | Completed | Sintetica SA | 394 | 2013-11-01 | 2021-06-29 |
Cataract (1) · Flatfoot (1) · Hernia, Inguinal (1) · Pain, Postoperative (1) · Schmid-Fraccaro syndrome (1)
chloroprocaine (3) · Ropivacaine (2) · 3-(cystein-S-yl)paracetamol (1) · Acetaminophen (1) · DMAC2L protein, human (1) · Injections (1) · Ophthalmic Solutions (1) · Saline Solution (1) · Solutions (1) · benoxinate (1)
Italy (4) · Switzerland (4) · Belgium (2) · Spain (2) · Austria (1) · Slovakia (1)
Claudio Camponovo, MD (3) · Andrea Saporito, MD (1) · Capdevila Xavier, MD (1) · Gerhard Garhoefer (1) · Guido Fanelli, MD (1) · Holger Sauer, MD (1) · John Van Delft, MD (1) · Jorge Alio, MD (1) · Laurent Delaunay, MD (1) · Marc Van de Velde, MD (1) · Martin Bauer, MD (1) · Milko Radicioni (1) · Oliver Kimberger, Prof (1) · Stefano Bonarelli, MD (1) · Stefano MD Bonarelli (1)
PMID 33610175, PMID 33976374, PMID 38489057
2014 (1)