Clinical trial • Phase III • Other

BENZYDAMINE HYDROCHLORIDE; 2,4 DICHLOROBENZYL ALCOHOL for Acute pharyngitis

Phase III trial of BENZYDAMINE HYDROCHLORIDE; 2,4 DICHLOROBENZYL ALCOHOL for Acute pharyngitis.

Overview

Trial Therapeutic Area
Other
Trial Disease
Acute pharyngitis
Trial Stage
Phase III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
11-07-2025

Trial design

Randomised, arms: test product doriduo (lozenge containing benzydamine hydrochloride and 2,4 dichlorobenzyl alcohol); active comparator mebocaína anti-inflam, 1.2 mg + 3 mg, comprimidos para chupar (compressed lozenge containing benzydamine hydrochloride and 2,4 dichlorobenzyl alcohol; marketing authorisation number 5407382 in pt indicated); placebo to test and comparator.-controlled Phase III trial in Germany.

Randomised
Yes
Comparator
Arms: Test product DoriDuo (lozenge containing benzydamine hydrochloride and 2,4 dichlorobenzyl alcohol); Active comparator Mebocaína Anti-Inflam, 1.2 mg + 3 mg, comprimidos para chupar (compressed lozenge containing benzydamine hydrochloride and 2,4 dichlorobenzyl alcohol; marketing authorisation number 5407382 in PT indicated); Placebo to Test and Comparator.
Target Sample Size
810
Trial Duration For Participant
4

Eligibility

Recruits 810 Vulnerable population not selected. Trial includes adults only (Age ≥ 18 years) and requires signed informed consent. Exclusion criteria explicitly exclude subjects with legal incapacity or other circumstances rendering the subject unable to understand the nature, scope and possible impact of the trial. No assent process described..

Pregnancy Exclusion
Pregnancy and lactation
Vulnerable Population
Vulnerable population not selected. Trial includes adults only (Age ≥ 18 years) and requires signed informed consent. Exclusion criteria explicitly exclude subjects with legal incapacity or other circumstances rendering the subject unable to understand the nature, scope and possible impact of the trial. No assent process described.

Inclusion criteria

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

Exclusion criteria

  • {"criterion_text":"- Patients with strong suspicion of streptococcus A infection (McIsaac Score ≥3 points)\n- 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\n- Known phenylketonuria\n- Immunodeficiency disorders (e.g. organ transplantation, HIV infection)\n- Severe neurologic and/or psychiatric disorders (including acute depressive mood / acute episode of depression)\n- Malignant ENT disorders within the previous 5 years\n- Known hypersensitivity to any of the ingredients of the trial medication\n- Known hypersensitivity to salicylic acid or other NSAIDs (e.g. ibuprofen, diclofenac)\n- Women of child-bearing potential who do not use a highly effective method of contraception (i.e. Pearl Index ≤ 1)\n- Pregnancy and lactation\n- Participation in another clinical trial during the trial and within the previous 30 days prior to screening\n- Positive rapid streptococcus A test (rapid antigen detection test) to exclude the major bacterial pathogen responsible for sore throat\n- Persons who are institutionalised by court order or regulatory action\n- 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\n- Legal incapacity and/or other circumstances rendering the subject unable to understand the nature, scope and possible impact of the trial\n- Patients, who take part in the clinical trial at the same time and live in the same household.\n- Purulent tonsillitis\n- 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\n- The use of systemic antibiotics / local antibiotics in the throat area within the previous 7 days prior to screening\n- 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\n- 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\n- The use of local anaesthetics for treatment of sore throat within the previous 6 hours prior to screening\n- The use of any systemic or local (i.e. in the throat area) antihistamines started within 2 weeks prior to screening"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- 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","definition_or_measurement_approach":"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"}

Recruitment

Planned Sample Size
810
Recruitment Window Months
8
Consent Approach
Signed informed consent is required from participants (Age ≥ 18 years). Subject information and informed consent form documents are listed (e.g. L1_SIS and ICF_Final V2_clean_redacted). No assent process for minors described; consent provided by the adult participant.

Geography

Total Number Of Sites
20
Total Number Of Participants
810

Germany

Earliest CTIS Part Ii Submission Date
21-08-2025
Latest Decision Or Authorization Date
19-09-2025
Processing Time Days
29
Number Of Sites
20
Number Of Participants
810

Sites

Site Name
Praxis Dr. med. Manuela Thinesse-Mallwitz
Department Name
General Physician
Contact Person Name
Manuela Thinesse-Mallwitz
Site Name
Praxis Dr. Mürbeth
Department Name
General Physician
Contact Person Name
Raymund Mürbeth
Contact Person Email
info@muerbeth.de
Site Name
HNO prax
Department Name
Specialist in Ear, Nose and Throat medicine
Contact Person Name
Christiane Müller- Agbonlahor
Contact Person Email
hofaue@hnoprax.de
Site Name
Medizinisches Versorgungszentrum Jung GbR
Department Name
General Physician
Contact Person Name
Thomas Jung
Contact Person Email
info@drs-jung.de
Site Name
medicoKIT GmbH
Department Name
General Physician
Contact Person Name
Thorsten Krause
Contact Person Email
buero@medicokit-goch.de
Site Name
Studienpraxis Heimeranplatz
Department Name
General Physician
Contact Person Name
Tamara Eckermann
Contact Person Email
info@hausarzt-heimeranplatz.de
Site Name
Ambenet GmbH Das Ambulante Behandlungsnetz
Department Name
General Physician
Contact Person Name
Hans-Detlev Stahl
Contact Person Email
studien@ambenet.de
Site Name
Praxis Dr. Joachim Weimer
Department Name
General Physician
Contact Person Name
Joachim Weimer
Contact Person Email
dr.joachimweimer@t-online.de
Site Name
Medizentrum Essen Borbeck
Department Name
General Physician
Contact Person Name
Axel Schäfer
Contact Person Email
axel.schaefer@mzeb.de
Site Name
Private Practice Dr. med. Christian Korte
Department Name
General Physician
Contact Person Name
Christian Korte
Contact Person Email
info@hno-landsberg.com
Site Name
Studienzentrum MOL, BAG Dres. E. Hippke & S. Runge
Department Name
Otolaryngologist, Allergist
Contact Person Name
Sonia Runge
Contact Person Email
mail@studienzentrum-mol.de
Site Name
Zentrum für klinische Forschung
Department Name
General Physician
Contact Person Name
Bastian Kirsch
Site Name
Studienzentrum Dresden, Praxisklinik am Altmarkt, HNO-Praxis
Department Name
Specialist in Ear, Nose and Throat medicine
Contact Person Name
Udo Schäfer
Contact Person Email
kontakt@hno-praxis-dresden.de
Site Name
HNO Praxis Dr. Thieme
Department Name
Specialist in Ear, Nose and Throat medicine
Contact Person Name
Uta Thieme
Contact Person Email
praxis@hno-thieme.de
Site Name
MVZ im Altstadt-Carree Fulda GmbH
Department Name
General Physician
Contact Person Name
Jörg Simon
Contact Person Email
simon.fulda@t-online.de
Site Name
Hausarztzentrum Butendorf
Department Name
General Physician
Contact Person Name
Stefan Schaub
Contact Person Email
info@hausarztzentrum.de
Site Name
BERUFSAUSÜBUNGSGEMEINSCHAFT DR.MED. JÖRG SCHULZE,DR.MED.MICHAEL SCHWERDTFEGER UND DR. ANDREI LEHMANN
Department Name
Specialist internal medicine
Contact Person Name
Jörg Schulze
Site Name
Private Practice Dr. med. Annette Biedermann
Department Name
General Physician
Contact Person Name
Annette Biedermann
Contact Person Email
info@praxis-biedermann.de
Site Name
Gemeinschaftspraxis Drs. Grosskopf
Department Name
General Physician
Contact Person Name
Josef Grosskopf
Contact Person Email
info@drs-grosskopf.de
Site Name
Private Practice Prof. Dr. med. Frederik M. Mader
Department Name
General Physician
Contact Person Name
Frederik M. Mader
Contact Person Email
mailbox@gpnd.de

Sponsor

Primary sponsor

Full Name
MEDICE Arzneimittel Puetter GmbH & Co. KG
Organisation Type
Pharmaceutical company
Country Of Registered Address
Germany

Contract research organisations

Name
Astrum CRO Germany GmbH
Responsibilities
codes: 1,10,11,12,2,5,6

Third parties

  • {"country":"Spain","full_name":"Lozy's Pharmaceuticals S.L.","duties_or_roles":"IMP Manufacturer","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"Astrum CRO Germany GmbH","duties_or_roles":"codes: 1,10,11,12,2,5,6","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"Staburo GmbH","duties_or_roles":"Randomization","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Germany","full_name":"EvidentlQ Germany GmbH","duties_or_roles":"code: 7","organisation_type":"Non-Pharmaceutical company"}

Investigational products

Investigational Product Name
DoriDuo
Active Substance
BENZYDAMINE HYDROCHLORIDE; 2,4 DICHLOROBENZYL ALCOHOL
Modality
Small molecule
Routes Of Administration
OROPHARYNGEAL USE
Route
OROPHARYNGEAL USE
Maximum Dose
Max daily dose 25.2 mg; max total dose 84 mg
Investigational Product Name
Mebocaína Anti-Inflam, 1.2 mg + 3 mg, comprimidos para chupar
Active Substance
BENZYDAMINE HYDROCHLORIDE; 2,4 DICHLOROBENZYL ALCOHOL
Modality
Small molecule
Routes Of Administration
OROPHARYNGEAL USE
Route
OROPHARYNGEAL USE
Authorisation Status
Marketing authorisation indicated (marketingAuthNumber: 5407382) with authorisationCountryCode PT
Maximum Dose
Max daily dose 25.2 mg; max total dose 84 mg
Investigational Product Name
Placebo to Test and Comparator
Modality
Other
Routes Of Administration
OROPHARYNGEAL USE
Route
OROPHARYNGEAL USE
Maximum Dose
Max daily dose 25.2 mg; max total dose 84 mg
Combination Treatment
Yes

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