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
- 10-10-2025
- First CTIS Authorization Date
- 11-12-2025
Trial design
Randomised, active comparator: mebocaína anti-inflam, 1.2 mg + 3 mg, comprimidos para chupar (compressed lozenge, marketed product). placebo arm: "placebo to test and comparator" (placebo to test and comparator). test product: doriduo (lozenge, active substances: benzydamine hydrochloride and 2,4 dichlorobenzyl alcohol). specific dosing schedule not detailed in the ctis metadata.-controlled Phase III trial in Germany.
- Randomised
- Yes
- Comparator
- Active comparator: Mebocaína Anti-Inflam, 1.2 mg + 3 mg, comprimidos para chupar (compressed lozenge, marketed product). Placebo arm: "Placebo to Test and Comparator" (placebo to test and comparator). Test product: DoriDuo (lozenge, active substances: benzydamine hydrochloride and 2,4 dichlorobenzyl alcohol). Specific dosing schedule not detailed in the CTIS metadata.
- Target Sample Size
- 810
Eligibility
Recruits 810 isVulnerablePopulationSelected: false. Legal incapacity and other circumstances rendering a subject unable to understand the nature, scope and possible impact of the trial are exclusion criteria ("Legal incapacity and/or other circumstances rendering the subject unable to understand the nature, scope and possible impact of the trial"). Signed informed consent is required from participants (adults only, inclusion criterion: "Age ≥ 18 years" and "Signed informed consent"). No assent/parental consent procedures are described; minors are excluded by the age criterion..
- Pregnancy Exclusion
- Pregnancy and lactation
- Vulnerable Population
- isVulnerablePopulationSelected: false. Legal incapacity and other circumstances rendering a subject unable to understand the nature, scope and possible impact of the trial are exclusion criteria ("Legal incapacity and/or other circumstances rendering the subject unable to understand the nature, scope and possible impact of the trial"). Signed informed consent is required from participants (adults only, inclusion criterion: "Age ≥ 18 years" and "Signed informed consent"). No assent/parental consent procedures are described; minors are excluded by the age criterion.
Inclusion criteria
- {"criterion_text":"- Age ≥ 18 years"}
- {"criterion_text":"- Signed informed consent"}
- {"criterion_text":"- Clinically diagnosed acute pharyngitis (defined as TPA value ≥5 points)"}
- {"criterion_text":"- Recent onset of symptoms (≤ 30 hours)"}
- {"criterion_text":"- Throat soreness scale ≥7 score points (TSS)"}
- {"criterion_text":"- 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
- {"criterion_text":"- Patients with strong suspicion of streptococcus A infection (McIsaac Score ≥3 points)"}
- {"criterion_text":"- 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"}
- {"criterion_text":"- Known phenylketonuria"}
- {"criterion_text":"- Immunodeficiency disorders (e.g. organ transplantation, HIV infection)"}
- {"criterion_text":"- Severe neurologic and/or psychiatric disorders (including acute depressive mood / acute episode of depression)"}
- {"criterion_text":"- Malignant ENT disorders within the previous 5 years"}
- {"criterion_text":"- Known hypersensitivity to any of the ingredients of the trial medication"}
- {"criterion_text":"- Known hypersensitivity to salicylic acid or other NSAIDs (e.g. ibuprofen, diclofenac)"}
- {"criterion_text":"- Women of child-bearing potential who do not use a highly effective method of contraception (i.e. Pearl Index ≤ 1)"}
- {"criterion_text":"- Pregnancy and lactation"}
- {"criterion_text":"- Participation in another clinical trial during the trial and within the previous 30 days prior to screening"}
- {"criterion_text":"- Persons who are institutionalised by court order or regulatory action"}
- {"criterion_text":"- 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"}
- {"criterion_text":"- Legal incapacity and/or other circumstances rendering the subject unable to understand the nature, scope and possible impact of the trial"}
- {"criterion_text":"- Patients, who take part in the clinical trial at the same time and live in the same household."}
- {"criterion_text":"- Purulent tonsillitis"}
- {"criterion_text":"- 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"}
- {"criterion_text":"- The use of systemic antibiotics / local antibiotics in the throat area within the previous 7 days prior to screening"}
- {"criterion_text":"- 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"}
- {"criterion_text":"- 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"}
- {"criterion_text":"- The use of local anaesthetics for treatment of sore throat within the previous 6 hours prior to screening"}
- {"criterion_text":"- The use of any systemic or local (i.e. in the throat area) antihistamines started within 2 weeks prior to screening"}
- {"criterion_text":"- Positive rapid streptococcus A test (rapid antigen detection test) to exclude the major bacterial pathogen responsible for sore throat"}
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
- Digital Remote Recruitment
- Yes
- Planned Sample Size
- 810
- Recruitment Window Months
- 6
- Consent Approach
- Signed informed consent is required from participants (inclusion criterion: "Signed informed consent"); participants must be ≥18 years. Subject information and informed consent form documents are included in the CTIS documents (multiple versions of 'L1_SIS and ICF' and related patient-facing material and emergency contact card). A pregnancy-specific ICF document is present ('L1_SIS and ICF_pregnant ICF_redacted'). Languages of the consent documents are not specified in the metadata.
Methods
- Landing page — document 'K1_Recruitement arrangement_Landing Page_Reich_35_Erfurt' (recruitment arrangement document listed; country: Germany)
- Social Media — document 'K1_Recruitement arrangement_Social Media_Reich_35_Erfurt' (social media recruitment; country: Germany)
- Flyer/Poster/Advertisement — documents 'K1_Recruitement arrangement_Flyer_Poster_Reich_35_Erfurt', 'K1_Recruitement arrangement_Advertisement_Reich_35_Erfurt', 'K1_Recruitement arrangement_Flyer' (printed materials for public recruitment; country: Germany)
- Newsletter — document 'K1_Recruitment arrangement_Newsletter_Vismane_34_Berlin' (newsletter-based outreach; country: Germany)
- Pre-Screening — document 'K1_Recruitement arrangement_Pre-Screening_Reich_35_Erfurt' (pre-screening procedures described; country: Germany)
- Patient recruitment procedure / Posters / Flyers — general patient recruitment procedure documents 'K1_Recruitment Arrangements_patient recruitment procedure' and related flyers/posters (country: Germany)
Geography
- Total Number Of Sites
- 30
- Total Number Of Participants
- 810
Germany
- Earliest CTIS Part Ii Submission Date
- 20-10-2025
- Latest Decision Or Authorization Date
- 11-03-2026
- Processing Time Days
- 142
- Number Of Sites
- 30
- Number Of Participants
- 810
Sites
- Site Name
- Medizentrum Essen Borbeck
- Department Name
- General Physician
- Principal Investigator Name
- Axel Schäfer
- Principal Investigator Email
- axel.schaefer@mzeb.de
- Contact Person Name
- Axel Schäfer
- Contact Person Email
- axel.schaefer@mzeb.de
- Site Name
- HNO Praxis Dr. Thieme
- Department Name
- Specialist in Ear, Nose and Throat medicine
- Principal Investigator Name
- Uta Thieme
- Principal Investigator Email
- praxis@hno-thieme.de
- Contact Person Name
- Uta Thieme
- Contact Person Email
- praxis@hno-thieme.de
- Site Name
- HNO-Praxis Alte Post
- Department Name
- HNO
- Principal Investigator Name
- Detlev Brehmer
- Principal Investigator Email
- info@hno-praxis-in-goettingen.de
- Contact Person Name
- Detlev Brehmer
- Contact Person Email
- info@hno-praxis-in-goettingen.de
- Site Name
- Analyze & Realize GmbH
- Department Name
- internal medicine
- Principal Investigator Name
- Olga Hassan
- Principal Investigator Email
- info@a-r.com
- Contact Person Name
- Olga Hassan
- Contact Person Email
- info@a-r.com
- Site Name
- medicoKIT GmbH
- Department Name
- General Physician
- Principal Investigator Name
- Thorsten Krause
- Principal Investigator Email
- buero@medicokit-goch.de
- Contact Person Name
- Thorsten Krause
- Contact Person Email
- buero@medicokit-goch.de
- Site Name
- Praxis Dr. Mürbeth
- Department Name
- General Physician
- Principal Investigator Name
- Raymund Mürbeth
- Principal Investigator Email
- info@muerbeth.de
- Contact Person Name
- Raymund Mürbeth
- Contact Person Email
- info@muerbeth.de
- Site Name
- Studienzentrum MOL, BAG Dres. E. Hippke & S. Runge
- Department Name
- Otolaryngologist, Allergist
- Principal Investigator Name
- Sonia Runge
- Principal Investigator Email
- mail@studienzentrum-mol.de
- Contact Person Name
- Sonia Runge
- Contact Person Email
- mail@studienzentrum-mol.de
- Site Name
- Studienpraxis Heimeranplatz
- Department Name
- General Physician
- Principal Investigator Name
- Tamara Eckermann
- Principal Investigator Email
- info@hausarzt-heimeranplatz.de
- Contact Person Name
- Tamara Eckermann
- Contact Person Email
- info@hausarzt-heimeranplatz.de
- Site Name
- SocraTec R&D Concepts in Drug Research and Development GmbH
- Department Name
- internal medicine
- Principal Investigator Name
- Victoria Reich
- Principal Investigator Email
- info-erfurt@socratec-pharma.de
- Contact Person Name
- Victoria Reich
- Contact Person Email
- info-erfurt@socratec-pharma.de
- Site Name
- Praxis Dr. med. Manuela Thinesse-Mallwitz
- Department Name
- General Physician
- Principal Investigator Name
- Manuela Thinesse-Mallwitz
- Principal Investigator Email
- info@praxis-thinesse-mallwitz.de
- Contact Person Name
- Manuela Thinesse-Mallwitz
- Contact Person Email
- info@praxis-thinesse-mallwitz.de
- Site Name
- Praxis für Allgemeinmedizin
- Department Name
- General physician
- Principal Investigator Name
- Florian Bauer
- Principal Investigator Email
- arztpraxisdr.bauer@gmx.de
- Contact Person Name
- Florian Bauer
- Contact Person Email
- arztpraxisdr.bauer@gmx.de
- Site Name
- Studienzentrum Dresden, Praxisklinik am Altmarkt, HNO-Praxis
- Department Name
- Specialist in Ear, Nose and Throat medicine
- Principal Investigator Name
- Udo Schäfer
- Principal Investigator Email
- kontakt@hno-praxis-dresden.de
- Contact Person Name
- Udo Schäfer
- Contact Person Email
- kontakt@hno-praxis-dresden.de
- Site Name
- Ambenet GmbH Das Ambulante Behandlungsnetz
- Department Name
- General Physician
- Principal Investigator Name
- Hans-Detlev Stahl
- Principal Investigator Email
- studien@ambenet.de
- Contact Person Name
- Hans-Detlev Stahl
- Contact Person Email
- studien@ambenet.de
- Site Name
- Hausarztzentrum Butendorf
- Department Name
- General Physician
- Principal Investigator Name
- Stefan Schaub
- Principal Investigator Email
- info@hausarztzentrum.de
- Contact Person Name
- Stefan Schaub
- Contact Person Email
- info@hausarztzentrum.de
- Site Name
- ENT-Research GmbH
- Department Name
- HNO
- Principal Investigator Name
- Boris Müller-Laue
- Principal Investigator Email
- info@ent-research.de
- Contact Person Name
- Boris Müller-Laue
- Contact Person Email
- info@ent-research.de
- Site Name
- Praxis für Allgemeinmedizin
- Department Name
- General physician
- Principal Investigator Name
- Ulrich Jäck
- Principal Investigator Email
- info@dr-jaeck.de
- Contact Person Name
- Ulrich Jäck
- Contact Person Email
- info@dr-jaeck.de
- Site Name
- HNO research GmbH
- Department Name
- HNO
- Principal Investigator Name
- Marine Tusunian
- Principal Investigator Email
- info@hno-itzehoe.de
- Contact Person Name
- Marine Tusunian
- Contact Person Email
- info@hno-itzehoe.de
- Site Name
- HNO Praxis Dr. Schuldt
- Department Name
- HNO
- Principal Investigator Name
- Tobias Schuldt
- Principal Investigator Email
- info@hno-dr-schuldt.de
- Contact Person Name
- Tobias Schuldt
- Contact Person Email
- info@hno-dr-schuldt.de
- Site Name
- HNO prax
- Department Name
- Specialist in Ear, Nose and Throat medicine
- Principal Investigator Name
- Christiane Müller- Agbonlahor
- Principal Investigator Email
- hofaue@hnoprax.de
- Contact Person Name
- Christiane Müller- Agbonlahor
- Contact Person Email
- hofaue@hnoprax.de
- Site Name
- Medizinisches Versorgungszentrum Jung GbR
- Department Name
- General Physician
- Principal Investigator Name
- Thomas Jung
- Principal Investigator Email
- info@drs-jung.de
- Contact Person Name
- Thomas Jung
- Contact Person Email
- info@drs-jung.de
- Site Name
- BERUFSAUSÜBUNGSGEMEINSCHAFT DR.MED. JÖRG SCHULZE,DR.MED.MICHAEL SCHWERDTFEGER UND DR. ANDREI LEHMANN
- Department Name
- Specialist internal medicine
- Principal Investigator Name
- Jörg Schulze
- Principal Investigator Email
- joerg.schulze@arztpraxis-jerichow.de
- Contact Person Name
- Jörg Schulze
- Contact Person Email
- joerg.schulze@arztpraxis-jerichow.de
- Site Name
- Private Practice for General Medicine Reinhold Vormann
- Department Name
- General Medicine
- Principal Investigator Name
- Reinhold Vormann
- Principal Investigator Email
- praxis@r-vormann.de
- Contact Person Name
- Reinhold Vormann
- Contact Person Email
- praxis@r-vormann.de
- Site Name
- Zentrum für klinische Forschung
- Department Name
- General Physician
- Principal Investigator Name
- Bastian Kirsch
- Principal Investigator Email
- b.kirsch@zentrum-fuer-klinische-forschung.de
- Contact Person Name
- Bastian Kirsch
- Contact Person Email
- b.kirsch@zentrum-fuer-klinische-forschung.de
- Site Name
- Studienzentrum Dr. Lassmann,
- Department Name
- HNO
- Principal Investigator Name
- Sabine Laßmann
- Principal Investigator Email
- dr.lassmann@t-online.de
- Contact Person Name
- Sabine Laßmann
- Contact Person Email
- dr.lassmann@t-online.de
- Site Name
- Gemeinschaftspraxis Drs. Grosskopf
- Department Name
- General Physician
- Principal Investigator Name
- Josef Grosskopf
- Principal Investigator Email
- info@drs-grosskopf.de
- Contact Person Name
- Josef Grosskopf
- Contact Person Email
- info@drs-grosskopf.de
- Site Name
- MVZ im Altstadt-Carree Fulda GmbH
- Department Name
- General Physician
- Principal Investigator Name
- Jörg Simon
- Principal Investigator Email
- simon.fulda@t-online.de
- Contact Person Name
- Jörg Simon
- Contact Person Email
- simon.fulda@t-online.de
- Site Name
- Private Practice Dr. med. Christian Korte
- Department Name
- General Physician
- Principal Investigator Name
- Christian Korte
- Principal Investigator Email
- info@hno-landsberg.com
- Contact Person Name
- Christian Korte
- Contact Person Email
- info@hno-landsberg.com
- Site Name
- Praxis Dr. Joachim Weimer
- Department Name
- General Physician
- Principal Investigator Name
- Joachim Weimer
- Principal Investigator Email
- dr.joachimweimer@t-online.de
- Contact Person Name
- Joachim Weimer
- Contact Person Email
- dr.joachimweimer@t-online.de
- Site Name
- HNO Eidelstedt
- Department Name
- HNO
- Principal Investigator Name
- Thiemo Kurzweg
- Principal Investigator Email
- info@hno-eidelstedt.de
- Contact Person Name
- Thiemo Kurzweg
- Contact Person Email
- info@hno-eidelstedt.de
- Site Name
- Private Practice Dr. med. Annette Biedermann
- Department Name
- General Physician
- Principal Investigator Name
- Annette Biedermann
- Principal Investigator Email
- info@praxis-biedermann.de
- Contact Person Name
- Annette Biedermann
- Contact Person Email
- info@praxis-biedermann.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 (as listed in sponsor duties)
Third parties
- {"country":"Germany","full_name":"AB Cube Germany GmbH","duties_or_roles":"code: 7","organisation_type":"Non-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":"code: 15 (Randomization)","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Spain","full_name":"Lozy's Pharmaceuticals S.L.","duties_or_roles":"code: 15 (IMP Manufacturer)","organisation_type":"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
- Authorisation Status
- prodAuthStatus: 1; euMpNumber: PRD12494753
- Maximum Dose
- maxDailyDoseAmount: 25.2 mg; maxTotalDoseAmount: 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
- prodAuthStatus: 2; marketingAuthNumber: 5407382; euMpNumber: PRD9177224
- Starting Dose
- 1.2 mg + 3 mg per lozenge (as per product name)
- Maximum Dose
- maxDailyDoseAmount: 25.2 mg; maxTotalDoseAmount: 84 mg
- Investigational Product Name
- Placebo to Test and Comparator
- Modality
- Other
- Routes Of Administration
- OROPHARYNGEAL USE
- Route
- OROPHARYNGEAL USE
- Maximum Dose
- maxDailyDoseAmount: 25.2 mg; maxTotalDoseAmount: 84 mg
- Combination Treatment
- Yes
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