Clinical trial NCT06843018: 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
Official title: A Prospective Open-label Multicenter Comparative Randomized Study in Parallel Groups to Evaluate the Efficacy and Safety of Using Different Doses of the Drug Graminidin With Anesthetic, a Metered-dose Spray for Local Application, for the Treatment of Acute Infectious-inflammatory Diseases of the Pharynx in Comparison With Therapy Using the Drug Septolete Total, Lozenges
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Pharyngitis Acute
Pharyngitis
Nasopharyngitis
Exacerbation of Chronic Pharyngitis
Lead sponsor: Valenta Pharm JSC
Sponsor class: INDUSTRY
First posted: 2025-02-24
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Combined primary efficacy endpoint: VAS + TPA
timeFrame: Day 1 (Visit 1) - Day 8 (Visit 3)
Secondary outcomes:
measure: Change in sore throat severity, 30 min
timeFrame: Day 1 (Visit 1)
measure: Change in sore throat severity, Visits 2 and 3
timeFrame: Day 5 (Visit 2), Day 8 (Visit 3)
measure: Change in the severity of clinical symptom
timeFrame: Day 5 (Visit 2)
measure: Proportion of patients with no erythema and edema of the pharyngeal mucosa
timeFrame: Day 5 (Visit 2), Day 8 (Visit 3)
measure: Proportion of patients with no erythema and edema of the tonsils
timeFrame: Day 5 (Visit 2), Day 8 (Visit 3)
measure: Proportion of patients without signs of intoxication syndrome
timeFrame: Day 5 (Visit 2), Day 8 (Visit 3)
measure: Overall frequency of adverse events
timeFrame: Screening, Day 1 (Visit 1) to Day 8 (Visit 3)
measure: Number of adverse events
timeFrame: Screening, Day 1 (Visit 1) to Day 8 (Visit 3)
measure: Frequency of drug-related adverse events
timeFrame: Day 1 (Visit 1) to Day 8 (Visit 3)
measure: Frequency of drug-related serious adverse events
timeFrame: Day 1 (Visit 1) to Day 8 (Visit 3)
measure: Proportion of patients discontinued due to adverse events
timeFrame: Day 1 (Visit 1) to Day 8 (Visit 3)
measure: Vital signs: systolic blood pressure
timeFrame: Screening, Day 1 (Visit 1), Day 5 (Visit 2), Day 8 (Visit 3)
measure: Vital signs: diastolic blood pressure
timeFrame: Screening, Day 1 (Visit 1), Day 5 (Visit 2), Day 8 (Visit 3)
measure: Vital signs: heart rate
timeFrame: Screening, Day 1 (Visit 1), Day 5 (Visit 2), Day 8 (Visit 3)
measure: Vital signs: body temperature (Celsius temperature scale)
timeFrame: Screening, Day 1 (Visit 1), Day 5 (Visit 2), Day 8 (Visit 3)
measure: Physical examination results: cardiovascular system
timeFrame: Screening, Day 1 (Visit 1), Day 5 (Visit 2), Day 8 (Visit 3)
measure: Physical examination results: respiratory system
timeFrame: Screening, Day 1 (Visit 1), Day 5 (Visit 2), Day 8 (Visit 3)
measure: Physical examination results: digestive tract
timeFrame: Screening, Day 1 (Visit 1), Day 5 (Visit 2), Day 8 (Visit 3)
measure: Physical examination results: endocrine system
timeFrame: Screening, Day 1 (Visit 1), Day 5 (Visit 2), Day 8 (Visit 3)
measure: Physical examination results: musculoskeletal system
timeFrame: Screening, Day 1 (Visit 1), Day 5 (Visit 2), Day 8 (Visit 3)
measure: Physical examination results: nervous system
timeFrame: Screening, Day 1 (Visit 1), Day 5 (Visit 2), Day 8 (Visit 3)
measure: Physical examination results: sensory systems
timeFrame: Screening, Day 1 (Visit 1), Day 5 (Visit 2), Day 8 (Visit 3)
measure: Physical examination results: skin/visible mucous membranes
timeFrame: Screening, Day 1 (Visit 1), Day 5 (Visit 2), Day 8 (Visit 3)
measure: Results of laboratory and instrumental examinations: clinical blood test - hemoglobin
timeFrame: Screening, Day 8 (Visit 3)
measure: Results of laboratory and instrumental examinations: clinical blood test - hematocrit
timeFrame: Screening, Day 8 (Visit 3)
measure: Results of laboratory and instrumental examinations: clinical blood test - red blood cell count
timeFrame: Screening, Day 8 (Visit 3)
measure: Results of laboratory and instrumental examinations: clinical blood test - platelet count
timeFrame: Screening, Day 8 (Visit 3)
measure: Results of laboratory and instrumental examinations: clinical blood test - leukocyte count
timeFrame: Screening, Day 8 (Visit 3)
measure: Results of laboratory and instrumental examinations: clinical blood test - erythrocyte sedimentation rate
timeFrame: Screening, Day 8 (Visit 3)
measure: Results of laboratory and instrumental examinations: clinical blood test - myelocytes
timeFrame: Screening, Day 8 (Visit 3)
measure: Results of laboratory and instrumental examinations: clinical blood test - band neutrophils
timeFrame: Screening, Day 8 (Visit 3)
measure: Results of laboratory and instrumental examinations: clinical blood test - segmented neutrophils
timeFrame: Screening, Day 8 (Visit 3)
measure: Results of laboratory and instrumental examinations: clinical blood test - eosinophils
timeFrame: Screening, Day 8 (Visit 3)
measure: Results of laboratory and instrumental examinations: clinical blood test - basophils
timeFrame: Screening, Day 8 (Visit 3)
measure: Results of laboratory and instrumental examinations: clinical blood test - monocytes
timeFrame: Screening, Day 8 (Visit 3)
measure: Results of laboratory and instrumental examinations: clinical blood test - lymphocytes
timeFrame: Screening, Day 8 (Visit 3)
measure: Results of laboratory and instrumental examinations: blood chemistry - glucose
timeFrame: Screening, Day 8 (Visit 3)
measure: Results of laboratory and instrumental examinations: blood chemistry - cholesterol
timeFrame: Screening, Day 8 (Visit 3)
measure: Results of laboratory and instrumental examinations: blood chemistry - protein
timeFrame: Screening, Day 8 (Visit 3)
measure: Results of laboratory and instrumental examinations: blood chemistry - bilirubin
timeFrame: Screening, Day 8 (Visit 3)
measure: Results of laboratory and instrumental examinations: blood chemistry - creatinine
timeFrame: Screening, Day 8 (Visit 3)
measure: Results of laboratory and instrumental examinations: blood chemistry - alkaline phosphatase
timeFrame: Screening, Day 8 (Visit 3)
measure: Results of laboratory and instrumental examinations: blood chemistry - alanine transaminase
timeFrame: Screening, Day 8 (Visit 3)
measure: Results of laboratory and instrumental examinations: blood chemistry - aspartate transaminase
timeFrame: Screening, Day 8 (Visit 3)
measure: Results of laboratory and instrumental examinations: urinalysis - specific gravity
timeFrame: Screening, Day 8 (Visit 3)
measure: Results of laboratory and instrumental examinations: urinalysis - pH
timeFrame: Screening, Day 8 (Visit 3)
measure: Results of laboratory and instrumental examinations: urinalysis - protein
timeFrame: Screening, Day 8 (Visit 3)
measure: Results of laboratory and instrumental examinations: urinalysis - glucose
timeFrame: Screening, Day 8 (Visit 3)
measure: Results of laboratory and instrumental examinations: urinalysis - red blood cells
timeFrame: Screening, Day 8 (Visit 3)
measure: Results of laboratory and instrumental examinations: urinalysis - white blood cells
timeFrame: Screening, Day 8 (Visit 3)
measure: Results of laboratory and instrumental examinations: blood chemistry - glomerular filtration rate
timeFrame: Screening, Day 8 (Visit 3)
Other outcomes:
Locations:
city: Engels
country: Russian Federation
facility: State autonomous health care institution "Engels City Clinical Hospital No. 1"
city: Kaliningrad
country: Russian Federation
facility: State Budgetary Healthcare Institution of the Kaliningrad Region "City Hospital No. 2."
city: Moscow
country: Russian Federation
facility: Unimed-C Jsc
city: Perm
country: Russian Federation
facility: Professors' Clinic LLC.
city: Saint Petersburg
country: Russian Federation
facility: Aurora MedFort LLC
city: Saint Petersburg
country: Russian Federation
facility: St. Petersburg State Budgetary Healthcare Institution "City Polyclinic No. 117"
city: Saint Petersburg
country: Russian Federation
facility: Limited Liability Company "Clinic Zvezdnaya"
city: Saint Petersburg
country: Russian Federation
facility: Limited Liability Company "Meili"
city: Saint Petersburg
country: Russian Federation
facility: LLC "Mariel Clinic"
city: Saratov
country: Russian Federation
facility: LLC "Center for DNA Research"
city: St. Petersburg
country: Russian Federation
facility: Limited Liability Company "Medical Center Eco-Safety"
city: Veliky Novgorod
country: Russian Federation
facility: LLC "Polyclinic Polimedika Veliky Novgorod"
Study officials:
References: