NCT02385097 is a Phase 3 clinical trial of Chloroprocaine HCl 2% in Axillary Nerve Block, sponsored by Sintetica SA.

Who is sponsoring NCT02385097?

NCT02385097 is sponsored by Sintetica SA.

What drugs are being tested in NCT02385097?

Interventions in NCT02385097: Chloroprocaine HCl 2%, Ropivacaine 0.75%.

What condition does NCT02385097 study?

NCT02385097 studies Axillary Nerve Block.

Is NCT02385097 still recruiting?

NCT02385097 is currently completed. Last updated 24 June 2021.

Are results published for NCT02385097?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2021-06-24 · How we verify

NCT02385097

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Prospective, Randomised, Non-inferiority Study of Chloroprocaine 2% and the Active Control Ropivacaine 0.75% (AstraZeneca) in Ultrasound-guided Axillary Nerve Block for Short-duration Distal Upper Limb Surgery

Completed Phase 3 Results posted Last updated 24 June 2021

What this trial tests

Phase 3 trial testing Chloroprocaine HCl 2% in Axillary Nerve Block in 211 participants. Completed in 1 May 2017.

Timeline

1 April 2015

Primary endpoint
1 May 2017

1 May 2017

Quick facts

Lead sponsor	Sintetica SA
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	other
Enrollment	211
Start date	1 April 2015
Primary completion	1 May 2017
Estimated completion	1 May 2017
Sites	1 location across Switzerland

Drugs / interventions tested

Chloroprocaine HCl 2% — full drug profile →
Ropivacaine 0.75%

Conditions studied

Axillary Nerve Block — all drugs for Axillary Nerve Block →

Sponsor

Sintetica SA — full company profile →

Who can join

18 and older, any sex, with Axillary Nerve Block. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Percentage of Participants With Successful Block for Distal Upper Limb Surgeries
Time frame: 45 min from the time of readiness of surgery
Percentage of patients with a successful block for distal upper limb surgeries, without any supplementation in the first 45 min, calculated from the time of readiness for surgery (complete sensory block).

Sponsor's own description

The Study evaluate the non-inferiority of Test product (Chloroprocaine 2%) versus Reference product (Ropivacaine 0.75%) in terms of proportion of subjects with a successful block for distal upper limb surgeries Successful block: anaesthesia adequate for the surgery without any supplementation in the first 45 min.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

A randomised, non-inferiority study of chloroprocaine 2% and ropivacaine 0.75% in ultrasound-guided axillary block.
Sulyok I, Camponovo C, Zotti O, Haslik W, et al · · 2021 · cited 2× · PMID 33976374 · DOI 10.1038/s41598-021-89483-y

Verify or expand the search:

Other Sintetica SA trials

Trials by the same sponsor.

NCT05926258 — Efficacy and Safety of Chloroprocaine 3% Gel and Oxybuprocaine 0.4% Eye Drops Anesthesia in Pediatric Population · Phase 3 · completed
NCT04685538 — Chloroprocaine 3% Gel Eye Drop as Topical Anestheticsin Phacoemulsification. · Phase 3 · completed
NCT04753710 — Efficacy, Safety and Tolerability Study of Chloroprocaine 3% Gel Eye Drops in Healthy Volunteers · Phase 2, PHASE3 · completed
NCT04779606 — Efficacy, Safety and Local Tolerability Study of Chloroprocaine 3% Gel Eye Drops in Healthy Volunteers · Phase 1, PHASE2 · completed
NCT03918798 — The Efficacy and Safety of Chloroprocaine 1% and 2% in Pediatric Population · Phase 2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02385097 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Sintetica SA
Last refreshed: 24 June 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02385097.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing