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| Name | Class |
|---|---|
| Pharmaxi LLC | INDUSTRY |
| Labor Dr. Fenner und Kollegen | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Verum mouth and throat rinse | Experimental | Formulation containing WO 6607 for oral administration (rinse and gargle). |
|
| Placebo mouth and throat rinse | Placebo Comparator | Formulation containing WO 6608 for oral administration (rinse and gargle). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Verum (WO 6607) | Device | Mouth and throat rinse and gargle solution |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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: 1. soreness, 2. difficulty swallowing (rated by the subject), 3. mucosal swelling of the throat and 4. oropharyngeal color (erythema) (assessed by the investigator) | Day 1 vs Day 4 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roman Fishchuk, MD | Central City Clinical Hospital of Ivano-Frankivsk | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central City Clinical Hospital of Ivano-Frankivsk | Ivano-Frankivsk | Ukraine |
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| ID | Term |
|---|---|
| D010612 | Pharyngitis |
| D012141 | Respiratory Tract Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D012140 | Respiratory Tract Diseases |
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| Placebo (WO 6608) |
| Device |
Mouth and throat rinse and gargle solution |
|
| 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) | 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) | 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 | 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 | 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) | 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 | 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 | 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 | 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 | 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 | Day 1, Day 2, Day 3, Day 7±1, Day 14±1 |
| D010038 |
| Otorhinolaryngologic Diseases |