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A prospective, multi-centre, randomised, 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
EU CTIS ID: 2025-521764-35-00
What this study is testing
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.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- Patients with strong suspicion of streptococcus A infection (McIsaac Score ≥3 points)
- 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
See the full eligibility criteria
- 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
- Patients with strong suspicion of streptococcus A infection (McIsaac Score ≥3 points)
- 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
- Positive rapid streptococcus A test (rapid antigen detection test) to exclude the major bacterial pathogen responsible for sore throat
- 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.
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.