NCT03583658 (DELICIOUS) is a Phase 3 clinical trial of ambroxol BIH1526 in Pharyngitis, sponsored by Sanofi.

Who is sponsoring NCT03583658?

NCT03583658 is sponsored by Sanofi.

What drugs are being tested in NCT03583658?

Interventions in NCT03583658: ambroxol BIH1526, placebo.

What condition does NCT03583658 study?

NCT03583658 studies Pharyngitis.

Is NCT03583658 still recruiting?

NCT03583658 is currently completed. Last updated 25 April 2022.

Last reviewed 2022-04-25 · How we verify

NCT03583658: DELICIOUS

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

Efficacy and Safety Study of New Ambroxol Hardboiled Lozenges in Acute Pharyngitis

Completed Phase 3 Last updated 25 April 2022

What this trial tests

Phase 3 trial testing ambroxol BIH1526 in Pharyngitis in 390 participants. Completed in 2 September 2018.

Timeline

30 June 2018

Primary endpoint
2 September 2018

2 September 2018

Quick facts

Lead sponsor	Sanofi
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	390
Start date	30 June 2018
Primary completion	2 September 2018
Estimated completion	2 September 2018
Sites	1 location across South Africa

Drugs / interventions tested

ambroxol BIH1526 — full drug profile →
placebo

Conditions studied

Pharyngitis — all drugs for Pharyngitis →

Sponsor

Sanofi — full company profile →

Who can join

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

Sponsor's own description

Primary Objective: To assess the efficacy of the new hard boiled Ambroxol lozenges 20 mg for the relief of sore throat pain in patients with acute pharyngitis. Secondary Objective: To assess the safety of the new hard boiled Ambroxol lozenges 20 mg in patients with acute pharyngitis.

Publications & conference data

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

A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Ambroxol Hard-Boiled Lozenges in Patients with Acute Pharyngitis.
Sousa R, Lakha DR, Brette S, Hitier S. · · 2019 · cited 6× · PMID 32026411 · DOI 10.1007/s41030-019-00100-w

Verify or expand the search:

Other recruiting trials for Pharyngitis

Currently open trials in the same condition.

NCT06859281 — Safety, Tolerability, and Pharmacokinetic Profile of Grammidin, a Metered Dose Topical Spray in Healthy Volunteers · Phase 1 · recruiting
NCT06857890 — Safety, Tolerability, and Pharmacokinetic Profile of Grammidin With Anesthetic, a Metered Dose Topical Spray in Healthy · Phase 1 · recruiting
NCT06843018 — Study to Evaluate the Efficacy and Safety of Different Doses of Graminidin With Anesthetic, a Metered Dose Topical Spray · Phase 2 · recruiting
NCT06114706 — Best Assessment of Sore Throat and Antibiotic Prescribing · NA · recruiting
NCT04471493 — Pediatric and Ambulatory Research in Infectious Diseases · recruiting

Other Sanofi trials

Trials by the same sponsor.

NCT07282795 — Post-marketing Surveillance Study for the Safety of Efluelda® Pre-filled Syringe · not yet recruiting
NCT06694025 — Post-marketing Surveillance Study for the Safety of Efluelda Tetra Pre-filled Syringe. · not yet recruiting
NCT07222189 — A Study to Investigate the Long-term Safety, Tolerability and Efficacy of Balinatunfib in Participants With Crohn's Dise · Phase 2 · not yet recruiting
NCT07484230 — A Phase 3 Study to Assess the Efficacy, Safety, and Tolerability of Itepekimab (Anti-IL-33 mAb) in Adult Japanese Partic · Phase 3 · not yet recruiting
NCT07547436 — A Study to Access Activity and Safety With SAR445399 Compared With Placebo in Participants Aged 18 to 80 Years of Age Wi · Phase 2 · recruiting

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 NCT03583658 (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 Sanofi
Last refreshed: 25 April 2022

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/NCT03583658.

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