Study to Evaluate the Efficacy and Safety of Using Different Doses of Graminidin With Anesthetic for the Treatment of Acute Infectious-inflammatory Diseases of the Pharynx in Comparison With Septolete Total, Lozenges

Phase 2

Recruiting

• Conditions: Pharyngitis Acute; Pharyngitis; Nasopharyngitis; Exacerbation of Chronic Pharyngitis
• Interventions: Drug: Grammidin with anesthetic; Drug: Septolete Total

• Registration Number: NCT06843018
• Lead Sponsor: Valenta Pharm JSC

Brief Summary

Study of the efficacy and safety of using different doses of the drug Grammidin with anesthetic, a metered-dose spray for local application, for the treatment of acute infectious and inflammatory diseases of the pharynx.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-11-14
• Status Verified: 2025-02
• Study First Submitted: 2025-02-17
• Study First Submitted QC: 2025-02-17
• Study First Posted: 2025-02-24
• Last Update Submitted: 2025-02-27
• Last Update Posted: 2025-03-04
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

1. Male or female patients aged 18 to 75 years inclusive.

2. 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:

   • Discomfort in the throat - symptoms of pharyngeal paresthesia (tickling in the throat, dryness in the throat, scratchy throat (sensation of a "foreign body"));
   • Pain in the throat (pain at rest, burning in the throat, pain when swallowing saliva).

3. Severity of the symptom "sore throat" from 55 mm to 80 mm on the Visual Analog Scale (VAS).

4. A score of 5 to 8 points on the Clinical Symptom Severity Scale for tonsillopharyngitis.

5. Absence of indications for systemic antibacterial therapy at the time of inclusion in the study.

6. Negative test result for β-hemolytic streptococcus.

7. Duration of disease symptoms not exceeding 3 days at the time of inclusion in the study.

8. 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).

9. Presence of a signed and dated informed consent from the patient to participate in the study.

Non-inclusion Criteria:

1. Trauma and/or burns of the oropharynx, scarlet fever, rubella, measles at the time of inclusion in the study and not earlier than 3 months before inclusion in the study.
2. Treatment with any systemic antibacterial agents within 14 days prior to inclusion in the study.
3. Use of non-steroidal anti-inflammatory drugs and/or decongestants within 12 hours prior to the randomization visit.
4. Body temperature at screening and randomization visits ≥ 38.5 °C.
5. Infectious-inflammatory diseases requiring combined or systemic antibacterial therapy.
6. Severe, decompensated, or unstable somatic diseases (any diseases or conditions that threaten the patient's life or worsen the prognosis of the underlying disease, as well as make it impossible for the patient to participate in the clinical study).
7. History of malignant neoplasms, except for patients whose disease has not recurred for the last 5 years.
8. Allergic history.
9. Participation in any other clinical study within 90 days prior to inclusion in the study.
10. Pregnancy or breastfeeding in women.
11. Refusal to use effective contraceptive methods during the study.
12. Alcoholism, drug addiction, abuse of psychotropic medications, including in history.
13. Smoking more than 10 cigarettes per day.
14. Positive urine test for narcotic substances and potent medications.
15. Vaccination of the patient within 21 days prior to inclusion in the study.
16. Other conditions that, in the opinion of the investigator, prevent the patient from being included in the study.

Exclusion Criteria

1. Erroneous inclusion of a patient in the study (not meeting inclusion/exclusion criteria at the time of randomization).
2. Ineffectiveness of therapy. Therapy will be considered ineffective if there is no clinical improvement by Visit 2 (Day 3-4 of therapy) - persistence or worsening of the symptom "sore throat" and catarrhal phenomena compared to baseline data. If excluded, the patient will be assigned alternative treatment at the discretion of the investigator.
3. Patient non-compliance (a patient is considered compliant if the number of applications of the study drug/comparison drug is not less than 17 and not more than 25).
4. Smoking more than 10 cigarettes per day.
5. The need for prohibited concomitant therapy.
6. If the investigator believes that further participation in the study would harm the patient.
7. Pregnancy of the patient or necessity for breastfeeding.
8. Gross violation by the patient of the study protocol procedures presented in the patient information sheet (PIS).
9. Withdrawal of informed consent (the patient's unwillingness to continue participation in the study).
10. Loss of contact with the patient (inability to reach the patient by mobile and home phone (if applicable), as well as through a contact person; there must be at least three documented attempts to contact the patient).
11. The emergence during the study of any diseases or conditions that worsen the patient's prognosis and make it impossible for the patient to continue participating in this clinical study.
12. Any other reasons, including administrative ones, that in the investigator's opinion would prevent the subject from completing the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Grammidin with anesthetic, 2 sprays every 6 hours	Grammidin with anesthetic	Patients in group 1 will receive the drug Grammidin with anesthetic, a metered-dose spray, with 2 sprays every 6 hours, three times a day after meals for a duration of 7 days.
Grammidin with anesthetic, 4 sprays every 6 hours	Grammidin with anesthetic	Patients in group 2 will receive the drug Grammidin with anesthetic, a metered-dose spray, with 4 sprays every 6 hours, three times a day after meals for a duration of 7 days.
Septolete Total, 1 lozenge every 6 hours	Septolete Total	Patients in group 3 will receive the drug Septolete Total, lozenges 3 mg + 1 mg, at a dosage of 1 lozenge every 6 hours, three times a day (maximum daily dose - 3 tablets) for a duration of 7 days.

Primary Outcome Measures

Name	Time	Method
Combined primary efficacy endpoint: VAS + TPA	Day 1 (Visit 1) - Day 8 (Visit 3)	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).

Secondary Outcome Measures

Name	Time	Method
Change in sore throat severity, 30 min	Day 1 (Visit 1)	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.
Change in sore throat severity, Visits 2 and 3	Day 5 (Visit 2), Day 8 (Visit 3)	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.
Change in the severity of clinical symptom	Day 5 (Visit 2)	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).
Proportion of patients with no erythema and edema of the pharyngeal mucosa	Day 5 (Visit 2), Day 8 (Visit 3)	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.
Proportion of patients with no erythema and edema of the tonsils	Day 5 (Visit 2), Day 8 (Visit 3)	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.
Proportion of patients without signs of intoxication syndrome	Day 5 (Visit 2), Day 8 (Visit 3)	Proportion of patients without signs of intoxication syndrome, assessed using a 4-point scale at Visits 2 and 3.
Overall frequency of adverse events	Screening, Day 1 (Visit 1) to Day 8 (Visit 3)	Overall frequency of adverse events (AEs) (number of patients with at least one AE reported)
Number of adverse events	Screening, Day 1 (Visit 1) to Day 8 (Visit 3)	Number of AEs stratified by severity and frequency
Frequency of drug-related adverse events	Day 1 (Visit 1) to Day 8 (Visit 3)	Frequency of AEs related to the use of the study drug/comparison drug
Frequency of drug-related serious adverse events	Day 1 (Visit 1) to Day 8 (Visit 3)	Frequency of serious adverse events (SAEs) related to the use of the study drug/comparison drug
Proportion of patients discontinued due to adverse events	Day 1 (Visit 1) to Day 8 (Visit 3)	Proportion of patients who discontinued treatment due to AEs
Vital signs: systolic blood pressure	Screening, Day 1 (Visit 1), Day 5 (Visit 2), Day 8 (Visit 3)	Systolic blood pressure (SBP, mmHg)
Vital signs: diastolic blood pressure	Screening, Day 1 (Visit 1), Day 5 (Visit 2), Day 8 (Visit 3)	Diastolic blood pressure (DBP, mmHg)
Vital signs: heart rate	Screening, Day 1 (Visit 1), Day 5 (Visit 2), Day 8 (Visit 3)	Heart rate (HR, bpm)
Vital signs: body temperature (Celsius temperature scale)	Screening, Day 1 (Visit 1), Day 5 (Visit 2), Day 8 (Visit 3)	Body temperature (Celsius temperature scale)
Physical examination results: cardiovascular system	Screening, Day 1 (Visit 1), Day 5 (Visit 2), Day 8 (Visit 3)	An assessment of the condition of the cardiovascular system on physical examination (normal condition or list of abnormal conditions, if any)
Physical examination results: respiratory system	Screening, Day 1 (Visit 1), Day 5 (Visit 2), Day 8 (Visit 3)	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)
Physical examination results: digestive tract	Screening, Day 1 (Visit 1), Day 5 (Visit 2), Day 8 (Visit 3)	An assessment of the condition of the digestive tract on physical examination (normal condition or list of abnormal conditions, if any)
Physical examination results: endocrine system	Screening, Day 1 (Visit 1), Day 5 (Visit 2), Day 8 (Visit 3)	An assessment of the condition of the endocrine system on physical examination (normal condition or list of abnormal conditions, if any)
Physical examination results: musculoskeletal system	Screening, Day 1 (Visit 1), Day 5 (Visit 2), Day 8 (Visit 3)	An assessment of the condition of the musculoskeletal system on physical examination (normal condition or list of abnormal conditions, if any)
Physical examination results: nervous system	Screening, Day 1 (Visit 1), Day 5 (Visit 2), Day 8 (Visit 3)	An assessment of the condition of the nervous system on physical examination (normal condition or list of abnormal conditions, if any)
Physical examination results: sensory systems	Screening, Day 1 (Visit 1), Day 5 (Visit 2), Day 8 (Visit 3)	An assessment of the condition of the sensory systems on physical examination (normal condition or list of abnormal conditions, if any)
Physical examination results: skin/visible mucous membranes	Screening, Day 1 (Visit 1), Day 5 (Visit 2), Day 8 (Visit 3)	An assessment of the condition of the skin/visible mucous membranes on physical examination (normal condition or list of abnormal conditions, if any)
Results of laboratory and instrumental examinations: clinical blood test - hemoglobin	Screening, Day 8 (Visit 3)	Hemoglobin (g/L)
Results of laboratory and instrumental examinations: clinical blood test - hematocrit	Screening, Day 8 (Visit 3)	Hematocrit (%)
Results of laboratory and instrumental examinations: clinical blood test - red blood cell count	Screening, Day 8 (Visit 3)	Red blood cell count (cells/L)
Results of laboratory and instrumental examinations: clinical blood test - platelet count	Screening, Day 8 (Visit 3)	Platelet count (cells/L)
Results of laboratory and instrumental examinations: clinical blood test - leukocyte count	Screening, Day 8 (Visit 3)	Leukocyte count (cells/L)
Results of laboratory and instrumental examinations: clinical blood test - erythrocyte sedimentation rate	Screening, Day 8 (Visit 3)	Erythrocyte sedimentation rate (mm/h)
Results of laboratory and instrumental examinations: clinical blood test - myelocytes	Screening, Day 8 (Visit 3)	Leukocyte formula (myelocytes, %)
Results of laboratory and instrumental examinations: clinical blood test - band neutrophils	Screening, Day 8 (Visit 3)	Leukocyte formula (band neutrophils, %)
Results of laboratory and instrumental examinations: clinical blood test - segmented neutrophils	Screening, Day 8 (Visit 3)	Leukocyte formula (segmented neutrophils, %)
Results of laboratory and instrumental examinations: clinical blood test - eosinophils	Screening, Day 8 (Visit 3)	Leukocyte formula (eosinophils, %)
Results of laboratory and instrumental examinations: clinical blood test - basophils	Screening, Day 8 (Visit 3)	Leukocyte formula (basophils, %)
Results of laboratory and instrumental examinations: clinical blood test - monocytes	Screening, Day 8 (Visit 3)	Leukocyte formula (monocytes, %)
Results of laboratory and instrumental examinations: clinical blood test - lymphocytes	Screening, Day 8 (Visit 3)	Leukocyte formula (lymphocytes, %)
Results of laboratory and instrumental examinations: blood chemistry - glucose	Screening, Day 8 (Visit 3)	Glucose concentration (mmol/L)
Results of laboratory and instrumental examinations: blood chemistry - cholesterol	Screening, Day 8 (Visit 3)	Total cholesterol concentration (mmol/L)
Results of laboratory and instrumental examinations: blood chemistry - protein	Screening, Day 8 (Visit 3)	Total protein concentration (g/L)
Results of laboratory and instrumental examinations: blood chemistry - bilirubin	Screening, Day 8 (Visit 3)	Total bilirubin concentration (micromol/L)
Results of laboratory and instrumental examinations: blood chemistry - creatinine	Screening, Day 8 (Visit 3)	Creatinine concentration (micromol/L)
Results of laboratory and instrumental examinations: blood chemistry - alkaline phosphatase	Screening, Day 8 (Visit 3)	Alkaline phosphatase activity (U/L)
Results of laboratory and instrumental examinations: blood chemistry - alanine transaminase	Screening, Day 8 (Visit 3)	Alanine transaminase activity (U/L)
Results of laboratory and instrumental examinations: blood chemistry - aspartate transaminase	Screening, Day 8 (Visit 3)	Aspartate transaminase activity (U/L)
Results of laboratory and instrumental examinations: urinalysis - specific gravity	Screening, Day 8 (Visit 3)	Specific gravity of the urine
Results of laboratory and instrumental examinations: urinalysis - pH	Screening, Day 8 (Visit 3)	pH of the urine
Results of laboratory and instrumental examinations: urinalysis - protein	Screening, Day 8 (Visit 3)	Protein concentration (g/L)
Results of laboratory and instrumental examinations: urinalysis - glucose	Screening, Day 8 (Visit 3)	Glucose concentration (mmol/L)
Results of laboratory and instrumental examinations: urinalysis - red blood cells	Screening, Day 8 (Visit 3)	Red blood cell content (number in sight)
Results of laboratory and instrumental examinations: urinalysis - white blood cells	Screening, Day 8 (Visit 3)	White blood cell content (number in sight)
Results of laboratory and instrumental examinations: blood chemistry - glomerular filtration rate	Screening, Day 8 (Visit 3)	Glomerular filtration rate calculated using blood creatinine levels and formula CKD-EPI

Trial Locations

Locations (12)

State autonomous health care institution "Engels City Clinical Hospital No. 1"; 🇷🇺 Engels, Russian Federation

State Budgetary Healthcare Institution of the Kaliningrad Region "City Hospital No. 2."; 🇷🇺 Kaliningrad, Russian Federation

Unimed-C Jsc; 🇷🇺 Moscow, Russian Federation

Professors' Clinic LLC.; 🇷🇺 Perm, Russian Federation

Aurora MedFort LLC; 🇷🇺 Saint Petersburg, Russian Federation

St. Petersburg State Budgetary Healthcare Institution "City Polyclinic No. 117"; 🇷🇺 Saint Petersburg, Russian Federation

Limited Liability Company "Clinic Zvezdnaya"; 🇷🇺 Saint Petersburg, Russian Federation

Limited Liability Company "Meili"; 🇷🇺 Saint Petersburg, Russian Federation

LLC "Mariel Clinic"; 🇷🇺 Saint Petersburg, Russian Federation

LLC "Center for DNA Research"; 🇷🇺 Saratov, Russian Federation

Limited Liability Company "Medical Center Eco-Safety"; 🇷🇺 St. Petersburg, Russian Federation

LLC "Polyclinic Polimedika Veliky Novgorod"; 🇷🇺 Veliky Novgorod, Russian Federation