Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Not authorised
Participants planned
810
Countries
1
Sites
20
acute pharyngitis
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.
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]
- Decision date (initial)
- 2025-09-19
- 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, Safety, Therapy
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
- 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
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.1 | LLT | 10001002 | Acute pharyngitis | 10021881 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- Age ≥ 18 years
- Signed informed consent
- Clinically diagnosed acute pharyngitis (defined as TPA value ≥5 points)
- Recent onset of symptoms (≤ 30 hours)
- Throat soreness scale ≥7 score points (TSS)
- 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
- Patients with strong suspicion of streptococcus A infection (McIsaac Score ≥3 points)
- Positive rapid streptococcus A test (rapid antigen detection test) to exclude the major bacterial pathogen responsible for sore throat
- Purulent tonsillitis
- 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
- The use of systemic antibiotics / local antibiotics in the throat area within the previous 7 days prior to screening
- 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
- 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
- The use of local anaesthetics for treatment of sore throat within the previous 6 hours prior to screening
- The use of any systemic or local (i.e. in the throat area) antihistamines started within 2 weeks prior to screening
- 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
- Known phenylketonuria
- Immunodeficiency disorders (e.g. organ transplantation, HIV infection)
- Severe neurologic and/or psychiatric disorders (including acute depressive mood / acute episode of depression)
- Malignant ENT disorders within the previous 5 years
- Known hypersensitivity to any of the ingredients of the trial medication
- Known hypersensitivity to salicylic acid or other NSAIDs (e.g. ibuprofen, diclofenac)
- Women of child-bearing potential who do not use a highly effective method of contraception (i.e. Pearl Index ≤ 1)
- Pregnancy and lactation
- Participation in another clinical trial during the trial and within the previous 30 days prior to screening
- Persons who are institutionalised by court order or regulatory action
- 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
- Legal incapacity and/or other circumstances rendering the subject unable to understand the nature, scope and possible impact of the trial
- 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
- 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
PRD12494753 · Product
- Active substance
- Benzydamine Hydrochloride
- Substance synonyms
- BENZINDAMINE HYDROCHLORIDE
- Pharmaceutical form
- LOZENGE
- Route of administration
- OROPHARYNGEAL USE
- Max daily dose
- 25.2 mg milligram(s)
- Max total dose
- 84 mg milligram(s)
- Max treatment duration
- 4 Week(s)
- Authorisation status
- Not Authorised
- ATC code
- R02AX — -
- MA holder
- MEDICE ARZNEIMITTEL PÜTTER GMBH & CO KG
- Paediatric formulation
- No
- Orphan designation
- No
Comparator 1
Mebocaína Anti-Inflam, 1.2 mg + 3 mg, comprimidos para chupar
PRD9177224 · Product
- Active substance
- Benzydamine Hydrochloride
- Pharmaceutical form
- COMPRESSED LOZENGE
- Route of administration
- OROPHARYNGEAL USE
- Max daily dose
- 25.2 mg milligram(s)
- Max total dose
- 84 mg milligram(s)
- Max treatment duration
- 4 Week(s)
- Authorisation status
- Authorised
- ATC code
- A01AD11 — VARIOUS
- Marketing authorisation
- 5407382
- MA holder
- STADA LDA.
- MA country
- Portugal
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- new packaging for unblinding purpose
Placebo 1
Placebo to Test and Comparator
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- Route of administration
- OROPHARYNGEAL USE
- Max daily dose
- 25.2 mg milligram(s)
- Max total dose
- 84 mg milligram(s)
- Max treatment duration
- 4 Day(s)
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
MEDICE Arzneimittel Puetter GmbH & Co. KG
3
Total trials
Commercial
- 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
| Organisation | City, country | Duties |
|---|---|---|
| Lozy's Pharmaceuticals S.L. ORG-100020153
|
Lekaroz, Spain | Other |
| Astrum CRO Germany GmbH ORG-100027709
|
Ismaning, Germany | On site monitoring, Code 10, Code 11, Code 12, Code 2, Code 5, Data management |
| Staburo GmbH ORG-100042826
|
Munich, Germany | Other |
| EvidentlQ Germany GmbH ORG-100046039
|
Munich, Germany | E-data capture |
Locations
1 EU/EEA country · 20 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Not authorised | 810 | 20 |
| Rest of world | — | 0 | — |
Investigational sites
Gemeinschaftspraxis Drs. Grosskopf
General Physician, Ahornstrasse 2a, 94574, Wallerfing
Praxis Dr. Joachim Weimer
General Physician, Paul-von-Schoenaich-Straße 29, 23858, Reinfeld
Medizinisches Versorgungszentrum Jung GbR
General Physician, Ditzenbacher Strasse 33, 73326, Deggingen
Private Practice Dr. med. Christian Korte
General Physician, Zörbigerstrasse 9, 06188, Landsberg
Private Practice Prof. Dr. med. Frederik M. Mader
General Physician, Talstraße 5, 93512, Nittendorf
Hausarztzentrum Butendorf
General Physician, Horster Strasse 137, Butendorf, Gladbeck
Praxis Dr. med. Manuela Thinesse-Mallwitz
General Physician, Faeustlestrasse 8, 80339, Munich
Studienzentrum MOL, BAG Dres. E. Hippke & S. Runge
Otolaryngologist, Allergist, Rosa-Luxemburg-Damm 1, 15366, Neuenhagen
MVZ im Altstadt-Carree Fulda GmbH
General Physician, Dalbergstrasse 22, Innenstadt, Fulda
Studienpraxis Heimeranplatz
General Physician, Heimeranplatz 2, 80339, Munich
Private Practice Dr. med. Annette Biedermann
General Physician, Marktstraße 19, 99444, Blankenhain
Praxis Dr. Mürbeth
General Physician, Schillerstraße 51, 93333, Neustadt an der Donau
Ambenet GmbH Das Ambulante Behandlungsnetz
General Physician, Wilhelm-Leuschner-Platz 12, Zentrum-Süd, Leipzig
Zentrum für klinische Forschung
General Physician, Berliner Str. 895, 51069, Köln
Medizentrum Essen Borbeck
General Physician, Huelsmannstrasse 6, Borbeck, Essen
Studienzentrum Dresden, Praxisklinik am Altmarkt, HNO-Praxis
Specialist in Ear, Nose and Throat medicine, Altmarkt 10 A, 01067, Dresden
HNO Praxis Dr. Thieme
Specialist in Ear, Nose and Throat medicine, Mercatorstraße 10-12, 47051, Duisburg
Berufsausübungsgemeinschaft Dr.med. Jörg Schulze,Dr.med.michael Schwerdtfeger Und Dr. Andrei Lehmann
Specialist internal medicine, Johannes-Lange-Str. 20, 39319, Jerichow
HNO prax
Specialist in Ear, Nose and Throat medicine, Hofaue 95, 42103, Wuppertal
medicoKIT GmbH
General Physician, Brueckenstrasse 42, 47574, Goch
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 14 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2025-521764-35-00_redacted | 1 |
| Protocol (for publication) | D1_Protocol_2025-521764-35-00_V2_clean_redacted | 2 |
| Protocol (for publication) | D4_Patient facing documents_eDiary specifications | 1 |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire_V1 | 1 |
| Protocol (for publication) | D4_Patient facing documents_TP and McIsaac Score | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_Flyer | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_patient recruitment procedure | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_Poster | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Final V2_clean_redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_pregnant ICF_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Patient facing documents_Emergency Contact Card | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_IMP2_Eng_redacted | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2025-521764-35-00_redacted | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-07-11 | Germany | Not acceptable 2025-09-15
|
2025-09-19 |