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This study aims to evaluete of tthe efficacy and safety of using different doses of the drug Grammidin with anesthetic, a metered dose topical spray, in the treatment of acute infectious and inflammatory pharyngeal diseases.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Grammidin with anesthetic, 2 sprays every 6 hours | Experimental | Patients in group 1 will receive the drug Grammidin with anesthetic,a metered dose topical spray, with 2 sprays every 6 hours, three times a day under fed conditions for 7 days. |
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| Grammidin with anesthetic, 4 sprays every 6 hours | Experimental | Patients in group 2 will receive the drug Grammidin with anesthetic, a metered dose topical spray, with 4 sprays every 6 hours, three times a day under fed conditions for 7 days. |
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| Septolete Total, 1 lozenge every 6 hours | Active Comparator | Patients in group 3 will receive the drug Septolete Total, lozenges 3 mg + 1 mg, 1 lozenge every 6 hours, three times daily (maximum daily dose - 3 lozenges) for 7 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Grammidin with anesthetic | Drug | Grammidin with anesthetic, a metered dose topical spray |
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| Measure | Description | Time Frame |
|---|---|---|
| Combined primary efficacy endpoint: VAS + TPA | The primary efficacy endpoint will consist of two components: Change in sore throat severity as measured by the Visual Analog Scale (VAS) one hour after the first administration of the drug (STPID1h). In accordance to VAS, 0 mm - no pain, while 100 mm is the worst pain ever. Change in the severity of clinical symptoms according to the Tonsillopharyngitis Assessment Scale (TPA) at Visit 3 (or at the time of complete recovery and treatment completion if it occurs earlier). In accordance to TPA, each symptom is assessed from 0 points (absence or weak symptom) to 2 points (strong symptom). | Day 1 (Visit 1) - Day 8 (Visit 3) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in sore throat severity, 30 min | Change in sore throat severity as measured by the Visual Analog Scale (VAS) 30 minutes after the first administration of the drug. In accordance to VAS, 0 mm - no pain, while 100 mm is the worst pain ever. | Day 1 (Visit 1) |
| Change in sore throat severity, Visits 2 and 3 |
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Inclusion Criteria:
Male or female patients aged 18 to 75 years inclusive.
Symptom "sore throat" due to infectious-inflammatory diseases of the pharynx (acute pharyngitis, acute nasopharyngitis, exacerbation of chronic pharyngitis) based on one or more of the following clinical manifestations:
Severity of the symptom "sore throat" from 55 mm to 80 mm on the Visual Analog Scale (VAS).
A score of 5 to 8 points on the Clinical Symptom Severity Scale for tonsillopharyngitis.
Absence of indications for systemic antibacterial therapy at the time of inclusion in the study.
Negative test result for β-hemolytic streptococcus.
Duration of disease symptoms not exceeding 3 days at the time of inclusion in the study.
Women with a negative pregnancy test who have used one or more of the following contraceptive methods for 8 weeks prior to and during the 3 weeks after the end of the study: intrauterine devices (IUDs), oral contraceptives, contraceptive patches, long-acting injectable contraceptives, double barrier contraceptive method; or women who are infertile (documented conditions: hysterectomy, tubal ligation, infertility, menopause for more than 1 year); or men using a double barrier contraceptive method (condom with spermicide) throughout the study and for 3 weeks after its conclusion or men who are infertile (documented conditions: vasectomy, infertility).
Signed and dated informed consent form.
Non-inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| State autonomous health care institution "Engels City Clinical Hospital No. 1" | Recruiting | Engel's | 413116 | Russia |
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|
| Septolete Total | Drug | Septolete Total, lozenges 3 mg + 1 mg |
|
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Change in sore throat severity as measured by the VAS at Visits 2 and 3. In accordance to VAS, 0 mm - no pain, while 100 mm is the worst pain ever. |
| Day 5 (Visit 2), Day 8 (Visit 3) |
| Change in the severity of clinical symptom | Change in the severity of clinical symptoms according to the Tonsillopharyngitis Assessment Scale at Visit 2. In accordance to TPA, each symptom is assessed from 0 points (absence or weak symptom) to 2 points (strong symptom). | Day 5 (Visit 2) |
| Proportion of patients with no erythema and edema of the pharyngeal mucosa | Proportion of patients with no erythema and edema of the pharyngeal mucosa according to the Erythema and Edema subscale of the Tonsillopharyngitis Clinical Symptom Severity Scale at Visits 2 and 3. | Day 5 (Visit 2), Day 8 (Visit 3) |
| Proportion of patients with no erythema and edema of the tonsils | Proportion of patients with no erythema and edema of the tonsils according to the Erythema and Edema subscale of the Tonsillopharyngitis Clinical Symptom Severity Scale at Visits 2 and 3. | Day 5 (Visit 2), Day 8 (Visit 3) |
| Proportion of patients without signs of intoxication syndrome | Proportion of patients without signs of intoxication syndrome, assessed using a 4-point scale at Visits 2 and 3. | Day 5 (Visit 2), Day 8 (Visit 3) |
| Overall frequency of adverse events | Overall frequency of adverse events (AEs) (number of patients with at least one AE reported) | Screening, Day 1 (Visit 1) to Day 8 (Visit 3) |
| Number of adverse events | Number of AEs stratified by severity and frequency | Screening, Day 1 (Visit 1) to Day 8 (Visit 3) |
| Frequency of drug-related adverse events | Frequency of AEs related to the use of the study drug/comparison drug | Day 1 (Visit 1) to Day 8 (Visit 3) |
| Frequency of drug-related serious adverse events | Frequency of serious adverse events (SAEs) related to the use of the study drug/comparison drug | Day 1 (Visit 1) to Day 8 (Visit 3) |
| Proportion of patients discontinued due to adverse events | Proportion of patients who discontinued treatment due to AEs | Day 1 (Visit 1) to Day 8 (Visit 3) |
| Vital signs: systolic blood pressure | Systolic blood pressure (SBP, mmHg) | Screening, Day 1 (Visit 1), Day 5 (Visit 2), Day 8 (Visit 3) |
| Vital signs: diastolic blood pressure | Diastolic blood pressure (DBP, mmHg) | Screening, Day 1 (Visit 1), Day 5 (Visit 2), Day 8 (Visit 3) |
| Vital signs: heart rate | Heart rate (HR, bpm) | Screening, Day 1 (Visit 1), Day 5 (Visit 2), Day 8 (Visit 3) |
| Vital signs: body temperature (Celsius temperature scale) | Body temperature (Celsius temperature scale) | Screening, Day 1 (Visit 1), Day 5 (Visit 2), Day 8 (Visit 3) |
| Physical examination results: cardiovascular system | An assessment of the condition of the cardiovascular system on physical examination (normal condition or list of abnormal conditions, if any) | Screening, Day 1 (Visit 1), Day 5 (Visit 2), Day 8 (Visit 3) |
| Physical examination results: respiratory system | An assessment of the condition of the respiratory system on physical examination (normal condition or list of abnormal conditions, if any)(normal condition or list of abnormal conditions, if any) | Screening, Day 1 (Visit 1), Day 5 (Visit 2), Day 8 (Visit 3) |
| Physical examination results: digestive tract | An assessment of the condition of the digestive tract on physical examination (normal condition or list of abnormal conditions, if any) | Screening, Day 1 (Visit 1), Day 5 (Visit 2), Day 8 (Visit 3) |
| Physical examination results: endocrine system | An assessment of the condition of the endocrine system on physical examination (normal condition or list of abnormal conditions, if any) | Screening, Day 1 (Visit 1), Day 5 (Visit 2), Day 8 (Visit 3) |
| Physical examination results: musculoskeletal system | An assessment of the condition of the musculoskeletal system on physical examination (normal condition or list of abnormal conditions, if any) | Screening, Day 1 (Visit 1), Day 5 (Visit 2), Day 8 (Visit 3) |
| Physical examination results: nervous system | An assessment of the condition of the nervous system on physical examination (normal condition or list of abnormal conditions, if any) | Screening, Day 1 (Visit 1), Day 5 (Visit 2), Day 8 (Visit 3) |
| Physical examination results: sensory systems | An assessment of the condition of the sensory systems on physical examination (normal condition or list of abnormal conditions, if any) | Screening, Day 1 (Visit 1), Day 5 (Visit 2), Day 8 (Visit 3) |
| Physical examination results: skin/visible mucous membranes | An assessment of the condition of the skin/visible mucous membranes on physical examination (normal condition or list of abnormal conditions, if any) | Screening, Day 1 (Visit 1), Day 5 (Visit 2), Day 8 (Visit 3) |
| Results of laboratory and instrumental examinations: clinical blood test - hemoglobin | Hemoglobin (g/L) | Screening, Day 8 (Visit 3) |
| Results of laboratory and instrumental examinations: clinical blood test - hematocrit | Hematocrit (%) | Screening, Day 8 (Visit 3) |
| Results of laboratory and instrumental examinations: clinical blood test - red blood cell count | Red blood cell count (cells/L) | Screening, Day 8 (Visit 3) |
| Results of laboratory and instrumental examinations: clinical blood test - platelet count | Platelet count (cells/L) | Screening, Day 8 (Visit 3) |
| Results of laboratory and instrumental examinations: clinical blood test - leukocyte count | Leukocyte count (cells/L) | Screening, Day 8 (Visit 3) |
| Results of laboratory and instrumental examinations: clinical blood test - erythrocyte sedimentation rate | Erythrocyte sedimentation rate (mm/h) | Screening, Day 8 (Visit 3) |
| Results of laboratory and instrumental examinations: clinical blood test - myelocytes | Leukocyte formula (myelocytes, %) | Screening, Day 8 (Visit 3) |
| Results of laboratory and instrumental examinations: clinical blood test - band neutrophils | Leukocyte formula (band neutrophils, %) | Screening, Day 8 (Visit 3) |
| Results of laboratory and instrumental examinations: clinical blood test - segmented neutrophils | Leukocyte formula (segmented neutrophils, %) | Screening, Day 8 (Visit 3) |
| Results of laboratory and instrumental examinations: clinical blood test - eosinophils | Leukocyte formula (eosinophils, %) | Screening, Day 8 (Visit 3) |
| Results of laboratory and instrumental examinations: clinical blood test - basophils | Leukocyte formula (basophils, %) | Screening, Day 8 (Visit 3) |
| Results of laboratory and instrumental examinations: clinical blood test - monocytes | Leukocyte formula (monocytes, %) | Screening, Day 8 (Visit 3) |
| Results of laboratory and instrumental examinations: clinical blood test - lymphocytes | Leukocyte formula (lymphocytes, %) | Screening, Day 8 (Visit 3) |
| Results of laboratory and instrumental examinations: blood chemistry - glucose | Glucose concentration (mmol/L) | Screening, Day 8 (Visit 3) |
| Results of laboratory and instrumental examinations: blood chemistry - cholesterol | Total cholesterol concentration (mmol/L) | Screening, Day 8 (Visit 3) |
| Results of laboratory and instrumental examinations: blood chemistry - protein | Total protein concentration (g/L) | Screening, Day 8 (Visit 3) |
| Results of laboratory and instrumental examinations: blood chemistry - bilirubin | Total bilirubin concentration (micromol/L) | Screening, Day 8 (Visit 3) |
| Results of laboratory and instrumental examinations: blood chemistry - creatinine | Creatinine concentration (micromol/L) | Screening, Day 8 (Visit 3) |
| Results of laboratory and instrumental examinations: blood chemistry - alkaline phosphatase | Alkaline phosphatase activity (U/L) | Screening, Day 8 (Visit 3) |
| Results of laboratory and instrumental examinations: blood chemistry - alanine transaminase | Alanine transaminase activity (U/L) | Screening, Day 8 (Visit 3) |
| Results of laboratory and instrumental examinations: blood chemistry - aspartate transaminase | Aspartate transaminase activity (U/L) | Screening, Day 8 (Visit 3) |
| Results of laboratory and instrumental examinations: urinalysis - specific gravity | Specific gravity of the urine | Screening, Day 8 (Visit 3) |
| Results of laboratory and instrumental examinations: urinalysis - pH | pH of the urine | Screening, Day 8 (Visit 3) |
| Results of laboratory and instrumental examinations: urinalysis - protein | Protein concentration (g/L) | Screening, Day 8 (Visit 3) |
| Results of laboratory and instrumental examinations: urinalysis - glucose | Glucose concentration (mmol/L) | Screening, Day 8 (Visit 3) |
| Results of laboratory and instrumental examinations: urinalysis - red blood cells | Red blood cell content (number in sight) | Screening, Day 8 (Visit 3) |
| Results of laboratory and instrumental examinations: urinalysis - white blood cells | White blood cell content (number in sight) | Screening, Day 8 (Visit 3) |
| Results of laboratory and instrumental examinations: blood chemistry - glomerular filtration rate | Glomerular filtration rate calculated using blood creatinine levels and formula CKD-EPI | Screening, Day 8 (Visit 3) |
| State Budgetary Healthcare Institution of the Kaliningrad Region "City Hospital No. 2." | Recruiting | Kaliningrad | Russia |
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| Unimed-C Jsc | Recruiting | Moscow | 119571 | Russia |
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| Professors' Clinic LLC. | Recruiting | Perm | 614070 | Russia |
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| Limited Liability Company "Medical Center Eco-Safety" | Recruiting | Saint Petersburg | 19119 | Russia |
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| Aurora MedFort LLC | Recruiting | Saint Petersburg | 194156 | Russia |
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| St. Petersburg State Budgetary Healthcare Institution "City Polyclinic No. 117" | Recruiting | Saint Petersburg | 194358 | Russia |
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| Limited Liability Company "Clinic Zvezdnaya" | Recruiting | Saint Petersburg | 196158 | Russia |
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| Limited Liability Company "Meili" | Recruiting | Saint Petersburg | 199406 | Russia |
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| LLC "Mariel Clinic" | Recruiting | Saint Petersburg | Russia |
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| LLC "Center for DNA Research" | Recruiting | Saratov | Russia |
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| LLC "Polyclinic Polimedika Veliky Novgorod" | Recruiting | Veliky Novgorod | Russia |
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| ID | Term |
|---|---|
| D010612 | Pharyngitis |
| D009304 | Nasopharyngitis |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D009302 | Nasopharyngeal Diseases |
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| ID | Term |
|---|---|
| D000777 | Anesthetics |
| C005298 | benoxinate |
| D001591 | Benzydamine |
| ID | Term |
|---|---|
| D002492 | Central Nervous System Depressants |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |
| D007191 | Indazoles |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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