Sore-throatNCT06244615
Clinical Trial of a Mouth and Throat Rinse for the Treatment of Acute Sore Throat
A study testing Verum (WO 6607) in people with Sore-throat and Upper Respiratory Infection, run by Dr. August Wolff GmbH & Co. KG Arzneimittel at 1 site in Ukraine.
Trial summary
The aim of this study is to confirm the efficacy, safety and tolerability of the Mouth and Throat Rinse in adult participants with acute sore throat (upper respiratory tract infection e.g., pharyngitis/laryngitis) compared to placebo. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Sore-throat, Upper Respiratory Infection
- What is being tested?
- Verum (WO 6607)
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 154 participants
- Where
- 1 siteUkraine
- Study dates
- 25 Mar 2024to 17 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects having clinical signs and symptoms of recent (less than 48 h) acute sore throat (upper respiratory tract infection) without signs of lower respiratory tract infection (total severity score for throat irritation baseline value ≥ 4).
- Centor Score of 0 to 3 points at screening.
- Female and male subjects with 18-75 years of age.
Who cannot join
- Known allergy to any of the components in the investigational product (Placebo or Verum) (i.e. SLS).
- Centor Score of 4 points at screening.
- Presence of exanthema.
- Presence of oral mucosal plaques e.g., soor.
- Presence of bacterial infection of the upper respiratory tract (confirmed by rapid screening test).
Trial locations and contacts
1 site in 1 country.
Ukraine1 site
Central City Clinical Hospital of Ivano-Frankivsk
Ivano-Frankivsk
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial of an Antiviral Mouth and Throat Rinse for the Treatment of Acute Sore Throat (Upper Respiratory Tract Infection e.g., Pharyngitis/Laryngitis)
The aim of this study is to confirm the efficacy, safety and tolerability of the Mouth and Throat Rinse in adult participants with acute sore throat (upper respiratory tract infection e.g., pharyngitis/laryngitis) compared to placebo.
- Conditions
- Sore-throat, Upper Respiratory Infection
- Being tested
- Verum (WO 6607), Placebo (WO 6608)
- Medical subject headings
- Pharyngitis, Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Verum (WO 6607)Device
Mouth and throat rinse and gargle solution
Placebo (WO 6608)Device
Mouth and throat rinse and gargle solution
| Study group | Role | What they receive |
|---|---|---|
| Verum mouth and throat rinse | Experimental | Formulation containing WO 6607 for oral administration (rinse and gargle). Receives: Device: Verum (WO 6607) |
| Placebo mouth and throat rinse | Placebo comparator | Formulation containing WO 6608 for oral administration (rinse and gargle). Receives: Device: Placebo (WO 6608) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in total severity score of throat irritation for subjective and objective symptoms during the clinical investigation (comparison between verum and placebo)
A total severity score for throat irritation will be calculated at each visit as the sum of the subjective and objective symptoms. Each of the four criteria on a scale from 0 to 4:
- soreness, 2. difficulty swallowing (rated by the subject), 3. mucosal swelling of the throat and 4. oropharyngeal color (erythema) (assessed by the investigator)
Measured: Day 1 vs Day 4
Secondary outcomes (11)
Evaluate the efficacy of the Verum Mouth and Throat Rinse compared to Placebo by analysing the detection of viruses
Combined nasal and oropharyngeal swab sampling for PCR detection of viruses including CT values reported for: Adenovirus, Coronaviruses including OC43, NL63, 229E and SARS-CoV-2, Influenza virus A and B, Parainfluenza virus 1-4, Rhinovirus, RSV) in adult subjects with acute sore throat (upper respiratory tract infection e.g., pharyngitis/laryngitis) compared to Placebo (Day 1 vs. Day 2 and Day 1 vs. Day 4)
Measured: Day 1 vs. Day 2,Day 1 vs. Day 4, Day 1 vs. Day 7 and Day 1 vs. Day 14
Evaluate the efficacy of the Verum Mouth and Throat Rinse compared to Placebo with respect to the subjective symtoms of throat soreness and difficulty swallowing
Comparison between Verum and Placebo:
Change Day 1 to Day 7±1 and Day 1 to Day 14±1 for each subjective symptom of throat soreness and difficulty swallowing (rated by the subject on a scale from 0 to 4)
Measured: Day 1 vs. Day 7±1 and Day 1 vs. Day 14±1
Evaluate the efficacy of the Verum Mouth and Throat Rinse compared to Placebo regarding the objective symptoms of mucous swelling and oropharyngeal color (erythema)
Comparison between Verum and Placebo:
Change Day 1 to Day 7±1 and Day 1 to Day 14±1 for each objective symptom of mucous swelling, oropharyngeal color (erythema) (assessed by the investigator on a scale from 0 to 4)
Measured: Day 1 vs. Day 7±1 and Day 1 vs. Day 14±1
Evaluate the efficacy of the Verum Mouth and Throat Rinse compared to Placebo regarding the recovery time
Comparison between Verum and Placebo:
Recovery time is defined as the time to improvement in total severity score of throat irritation value to ≤ 4, provided the score for each criterion is not > 1
Measured: Day 1 vs. Day 7 and Day 1 vs. Day 14
Evaluate the efficacy of the Verum Mouth and Throat Rinse compared to Placebo regarding the proportion of rebound after treatment phase
Comparison between Verum and Placebo:
Number of patients (%) with a rebound after treatment phase. Rebound is defined as worsening in total severity score of throat irritation value
Measured: Day 1 vs. Day 7 and Day 1 vs. Day 14
Evaluate the efficacy of the Verum Mouth and Throat Rinse compared to Placebo regarding the proportion of expansion of the symptoms (e.g., subsequent bronchitis)
Comparison between Verum and Placebo:
Number of patients in percent (%) having an expansion of the symptoms (e.g., subsequent bronchitis)
Measured: Day 1 vs. Day 7 and Day 1 vs. Day 14
Evaluate the efficacy of the Verum Mouth and Throat Rinse compared to Placebo regarding the need for further medical intervention or treatments such as rescue therapy or pain medication
Comparison between Verum and Placebo:
Number of patients with the need for further medical intervention or treatments such as rescue therapy or pain medication
Measured: Day 1 vs. Day 7 and Day 1 vs. Day 14
Evaluate the efficacy of the Verum Mouth and Throat Rinse compared to Placebo regarding the presence of Metapneumovirus and Bocavirus
Comparison between Verum and Placebo:
Combined nasal and oropharyngeal swab sampling for PCR detection of viruses without CT values reported for Metapneumovirus and Bocavirus
Measured: Day 1 vs. Day 4
Global judgement of efficacy by the patient
The global judgement of efficacy (throat soreness and difficulty swallowing) will be assessed according to the severity score: 0= none, 1= mild, 2= moderate, 3= severe, 4= very severe
Measured: Day 1 vs. Day 2, Day 1 vs. Day 7, Day 1 vs. Day 14
Global judgement of efficacy by the investigator
The global judgement of efficacy (mucous swelling and oropharyngeal color (erythema)) will be assessed according to the following scale: 0= none, 1= mild, 2= moderate, 3= severe, 4= very severe
Measured: Day 1 vs. Day 2, Day 1 vs. Day 7, Day 1 vs. Day 14
Evaluate the safety of the Verum Mouth and Throat Rinse in adult subjects with acute sore throat (upper respiratory tract infection e.g., pharyngitis/laryngitis)
The safety will be assessed through adverse events
Measured: Day 1, Day 2, Day 3, Day 7±1, Day 14±1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2024
- Study start25 Mar 2024
- Primary completion17 Feb 2025
- Study completion17 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sore-throatStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. August Wolff GmbH & Co. KG Arzneimittel
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pharmaxi LLC, Labor Dr. Fenner und Kollegen
- Responsible party
- Sponsor
- Investigators
- Roman Fishchuk, MD, Principal investigator, Central City Clinical Hospital of Ivano-Frankivsk
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06244615
- Sponsor's protocol ID
- LSMR-01/2022
- Status last verified
- Apr 2025
- First submitted
- 19 Dec 2023
- Last updated
- 11 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial of an Antiviral Mouth and Throat Rinse for the Treatment of Acute Sore Throat (Upper Respiratory Tract Infection e.g., Pharyngitis/Laryngitis)
- ClinicalTrials.gov ID
- NCT06244615
- Acronym / sponsor ID
- LSMR-01/2022
- Conditions
- Sore-throat, Upper Respiratory Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Dr. August Wolff GmbH & Co. KG ArzneimittelIndustry (pharma, biotech, devices)
- Collaborators
- Pharmaxi LLC, Labor Dr. Fenner und Kollegen
- Study start
- 25 Mar 2024 (actual)
- Primary completion
- 17 Feb 2025 (actual)
- Study completion
- 17 Feb 2025 (actual)
- First posted
- 6 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to confirm the efficacy, safety and tolerability of the Mouth and Throat Rinse in adult participants with acute sore throat (upper respiratory tract infection e.g., pharyngitis/laryngitis) compared to placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Verum mouth and throat rinse | Experimental | Device: Verum (WO 6607)Formulation containing WO 6607 for oral administration (rinse and gargle). |
| Placebo mouth and throat rinse | Placebo comparator | Device: Placebo (WO 6608)Formulation containing WO 6608 for oral administration (rinse and gargle). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects having clinical signs and symptoms of recent (less than 48 h) acute sore throat (upper respiratory tract infection) without signs of lower respiratory tract infection (total severity score for throat irritation baseline value ≥ 4).
- Centor Score of 0 to 3 points at screening.
- Female and male subjects with 18-75 years of age.
Key exclusion criteria (5 listed)
- Known allergy to any of the components in the investigational product (Placebo or Verum) (i.e. SLS).
- Centor Score of 4 points at screening.
- Presence of exanthema.
- Presence of oral mucosal plaques e.g., soor.
- Presence of bacterial infection of the upper respiratory tract (confirmed by rapid screening test).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Verum (WO 6607)Mouth and throat rinse and gargle solution | Device | Verum mouth and throat rinse |
| Placebo (WO 6608)Mouth and throat rinse and gargle solution | Device | Placebo mouth and throat rinse |
Primary outcome
Change in total severity score of throat irritation for subjective and objective symptoms during the clinical investigation (comparison between verum and placebo)
Time frame: Day 1 vs Day 4
A total severity score for throat irritation will be calculated at each visit as the sum of the subjective and objective symptoms. Each of the four criteria on a scale from 0 to 4: 1. soreness, 2. difficulty swallowing (rated by the subject), 3. mucosal swelling of the throat and 4. oropharyngeal color (erythema) (assessed by the investigator)
11 secondary outcomes
Evaluate the efficacy of the Verum Mouth and Throat Rinse compared to Placebo by analysing the detection of viruses
Time frame: Day 1 vs. Day 2,Day 1 vs. Day 4, Day 1 vs. Day 7 and Day 1 vs. Day 14
Evaluate the efficacy of the Verum Mouth and Throat Rinse compared to Placebo with respect to the subjective symtoms of throat soreness and difficulty swallowing
Time frame: Day 1 vs. Day 7±1 and Day 1 vs. Day 14±1
Evaluate the efficacy of the Verum Mouth and Throat Rinse compared to Placebo regarding the objective symptoms of mucous swelling and oropharyngeal color (erythema)
Time frame: Day 1 vs. Day 7±1 and Day 1 vs. Day 14±1
Evaluate the efficacy of the Verum Mouth and Throat Rinse compared to Placebo regarding the recovery time
Time frame: Day 1 vs. Day 7 and Day 1 vs. Day 14
Evaluate the efficacy of the Verum Mouth and Throat Rinse compared to Placebo regarding the proportion of rebound after treatment phase
Time frame: Day 1 vs. Day 7 and Day 1 vs. Day 14
Evaluate the efficacy of the Verum Mouth and Throat Rinse compared to Placebo regarding the proportion of expansion of the symptoms (e.g., subsequent bronchitis)
Time frame: Day 1 vs. Day 7 and Day 1 vs. Day 14
Evaluate the efficacy of the Verum Mouth and Throat Rinse compared to Placebo regarding the need for further medical intervention or treatments such as rescue therapy or pain medication
Time frame: Day 1 vs. Day 7 and Day 1 vs. Day 14
Evaluate the efficacy of the Verum Mouth and Throat Rinse compared to Placebo regarding the presence of Metapneumovirus and Bocavirus
Time frame: Day 1 vs. Day 4
Global judgement of efficacy by the patient
Time frame: Day 1 vs. Day 2, Day 1 vs. Day 7, Day 1 vs. Day 14
Global judgement of efficacy by the investigator
Time frame: Day 1 vs. Day 2, Day 1 vs. Day 7, Day 1 vs. Day 14
Evaluate the safety of the Verum Mouth and Throat Rinse in adult subjects with acute sore throat (upper respiratory tract infection e.g., pharyngitis/laryngitis)
Time frame: Day 1, Day 2, Day 3, Day 7±1, Day 14±1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roman Fishchuk, MD principal investigator
Central City Clinical Hospital of Ivano-Frankivsk
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Verum (WO 6607) in people with Sore-throat and Upper Respiratory Infection, run by Dr. August Wolff GmbH & Co. KG Arzneimittel at 1 site in Ukraine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ukraine. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in total severity score of throat irritation for subjective and objective symptoms during the clinical investigation (comparison between verum and placebo) (time frame: Day 1 vs Day 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2025.