A prospective, randomised, multi-centre, double-blind, placebo-controlled Phase III trial to investigate the efficacy and safety of lozenges with benzydamine hydrochloride and dichlorobenzyl alcohol in the symptomatic treatment of patients suffering from acute pharyngitis

Overview

Sponsor-declared trial summary

Key facts

Sponsor

MEDICE Arzneimittel Puetter GmbH & Co. KG

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Otorhinolaryngologic Diseases [C09]

Trial duration

27 Jan 2026 → ongoing

Decision date (initial)

2025-12-11

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

MEDICE Arzneimittel Pütter GmbH Co. KG

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Therapy, Safety

To investigate the efficacy of lozenges with benzydamine hydrochloride and dichlorobenzyl alcohol in the symptomatic treatment of patients suffering from acute pharyngitis in terms of non-inferiority compared to an active comparator and superiority compared to placebo.

Secondary objectives 1

1. To investigate the safety and tolerability of lozenges with benzydamine hydrochloride and dichlorobenzyl alcohol compared to placebo and an active comparator in the symptomatic treatment of patients suffering from acute pharyngitis

Conditions and MedDRA coding

acute pharyngitis

Regulatory references

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Age ≥ 18 years
2. Signed informed consent
3. Clinically diagnosed acute pharyngitis (defined as TPA value ≥5 points)
4. Recent onset of symptoms (≤ 30 hours)
5. Throat soreness scale ≥7 score points (TSS)
6. Patients having a private internet-enabled electronic device (e.g. mobile phone, smartphone, tablet, PC) at that can be used for the entire duration of the clinical trial

Exclusion criteria 23

1. Patients with strong suspicion of streptococcus A infection (McIsaac Score ≥3 points)
2. Positive rapid streptococcus A test (rapid antigen detection test) to exclude the major bacterial pathogen responsible for sore throat
3. Purulent tonsillitis
4. Severe inflammations of the throat or throat pain that are accompanied by either high fever (≥ 38,5°C, oral (sublingual)), and / or nausea and/or vomiting
5. The use of systemic antibiotics / local antibiotics in the throat area within the previous 7 days prior to screening
6. The use of any systemic analgesics / local analgesics in the throat area (e.g. non-steroidal drugs, acetylsalicylic acid (> 100 mg), paracetamol) within the previous 6 hours prior to screening
7. The use of any systemic anti-inflammatory drug / local anti-inflammatory drug in the throat area (e.g. glucocorticoids) within the previous 2 weeks prior to screening
8. The use of local anaesthetics for treatment of sore throat within the previous 6 hours prior to screening
9. The use of any systemic or local (i.e. in the throat area) antihistamines started within 2 weeks prior to screening
10. Patients with any regular consumption of the use of cannabis. and / or any other drugs illegal in Germany (e.g. heroin) and / or alcohol abuse
11. Known phenylketonuria
12. Immunodeficiency disorders (e.g. organ transplantation, HIV infection)
13. Severe neurologic and/or psychiatric disorders (including acute depressive mood / acute episode of depression)
14. Malignant ENT disorders within the previous 5 years
15. Known hypersensitivity to any of the ingredients of the trial medication
16. Known hypersensitivity to salicylic acid or other NSAIDs (e.g. ibuprofen, diclofenac)
17. Women of child-bearing potential who do not use a highly effective method of contraception (i.e. Pearl Index ≤ 1)
18. Pregnancy and lactation
19. Participation in another clinical trial during the trial and within the previous 30 days prior to screening
20. Persons who are institutionalised by court order or regulatory action
21. Patients, who are members of the staff of the clinical trial site, staff of the sponsor or involved Clinical Research Organisation (CRO), the investigator him- / herself or close relatives of the investigator
22. Legal incapacity and/or other circumstances rendering the subject unable to understand the nature, scope and possible impact of the trial
23. Patients, who take part in the clinical trial at the same time and live in the same household.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Superiority of IMP 1 in comparison to IMP 3 (Placebo) and for non-inferiority of IMP 1 in comparison to IMP 2 (reference) and is defined as area Under Curve (AUC) of changes from Baseline in Throat Soreness Intensity Scale (TSS) over the time course of 2 hours after first application on Day 0

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

MEDICE Arzneimittel Puetter GmbH & Co. KG

Sponsor organisation

MEDICE Arzneimittel Puetter GmbH & Co. KG

Address

Kuhloweg 37, Kuhlo Kuhlo

City

Iserlohn

Postcode

58638

Country

Germany

Scientific contact point

Organisation

MEDICE Arzneimittel Puetter GmbH & Co. KG

Contact name

Dr. Anne Schumacher-Stimpfl

Public contact point

Organisation

MEDICE Arzneimittel Puetter GmbH & Co. KG

Contact name

Dr. Anne Schumacher-Stimpfl

Third parties 4

Locations

1 EU/EEA country · 29 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Oversight and notifications

Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77

Temporary halts 1 · Art. 38 CTR

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 32 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

6 submissions — initial application plus substantial / non-substantial modifications