Study to Evaluate the Efficacy and Safety of Different Doses of Graminidin With Anesthetic, a Metered Dose Topical Spray, in the Treatment of Acute Infectious and Inflammatory Pharyngeal Diseases Compared With Drug Septolete Total, Lozenges

Официальное название

A Prospective, Open-label, Multicenter, Comparative, Randomised, Parallel-group Study to Evaluate the Efficacy and Safety of Different Doses of the Drug Graminidin With Anesthetic, a Metered Dose Topical Spray, in the Treatment of Acute Infectious and Inflammatory Pharyngeal Diseases Compared With Drug Septolete Total, Lozenges

Обзор

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.

Вмешательства

• Препарат Grammidin with anesthetic
  Grammidin with anesthetic, a metered dose topical spray
• Препарат Septolete Total
  Septolete Total, lozenges 3 mg + 1 mg

Первичные конечные точки

• Combined primary efficacy endpoint: VAS + TPA [Срок оценки: Day 1 (Visit 1) - Day 8 (Visit 3)]

Вторичные конечные точки (12)

• Change in sore throat severity, 30 min [Срок оценки: Day 1 (Visit 1)]
• Change in sore throat severity, Visits 2 and 3 [Срок оценки: Day 5 (Visit 2), Day 8 (Visit 3)]
• Change in the severity of clinical symptom [Срок оценки: Day 5 (Visit 2)]
• Proportion of patients with no erythema and edema of the pharyngeal mucosa [Срок оценки: Day 5 (Visit 2), Day 8 (Visit 3)]
• Proportion of patients with no erythema and edema of the tonsils [Срок оценки: Day 5 (Visit 2), Day 8 (Visit 3)]
• Proportion of patients without signs of intoxication syndrome [Срок оценки: Day 5 (Visit 2), Day 8 (Visit 3)]
• Overall frequency of adverse events [Срок оценки: Screening, Day 1 (Visit 1) to Day 8 (Visit 3)]
• Number of adverse events [Срок оценки: Screening, Day 1 (Visit 1) to Day 8 (Visit 3)]
• Frequency of drug-related adverse events [Срок оценки: Day 1 (Visit 1) to Day 8 (Visit 3)]
• Frequency of drug-related serious adverse events [Срок оценки: Day 1 (Visit 1) to Day 8 (Visit 3)]
• Proportion of patients discontinued due to adverse events [Срок оценки: Day 1 (Visit 1) to Day 8 (Visit 3)]
• Vital signs: systolic blood pressure [Срок оценки: Screening, Day 1 (Visit 1), Day 5 (Visit 2), Day 8 (Visit 3)]

Критерии участия

Критерии включения

• 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:

• Unpleasant sensations/discomfort in the throat - symptoms of pharyngeal paresthesia (scratchy throat, dryness or sore sensation ("foreign body" sensation));
• Painful sensations in the throat, including sore throat at rest, throat burning, or pain upon swallowing saliva;
• 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:

• 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.
• Treatment with any systemic antibacterial agents within 14 days prior to inclusion in the study.
• Use of non-steroidal anti-inflammatory drugs and/or decongestants within 12 hours prior to the randomization visit.
• Body temperature at screening and randomization visits ≥ 38.5 °C.
• Infectious-inflammatory diseases requiring combined or systemic antibacterial therapy.
• 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).
• History of malignancy, exept for subjects who have been disease-free for at least 5 years prior to screening.
• Allergic history.
• Participation in any other clinical study within 90 days prior to inclusion in the study.
• Pregnancy or breastfeeding in women.
• Refusal to use effective contraceptive methods during the study.
• Alcoholism, drug addiction, abuse of psychotropic medications, including in history.
• Smoking more than 10 cigarettes per day.
• Positive urine test for narcotic substances and potent medications.
• Vaccination within 21 days prior to study enrollment.
• Other conditions that, in the opinion of the investigator, prevent the patient from being included in the study.

Критерии исключения

• Erroneous inclusion of a patient in the study (not meeting inclusion/exclusion criteria at the time of randomization).
• 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.
• 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).
• Smoking more than 10 cigarettes per day.
• Requirement for prohibited concomitant therapy.
• The investigator determines that continued participation in the study may pose a risk to the subject's safety or well-being.
• Pregnancy or breastfeeding.
• Gross violation by the patient of the study protocol procedures presented in the patient information sheet (PIS).
• Withdrawal of informed consent (the patient's unwillingness to continue participation in the study).
• 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).
• 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.
• Any other reasons, including administrative ones, that in the investigator's judgment would prevent the subject from completing the study.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Россия · 12 центров

• State autonomous health care institution "Engels City Clinical Hospital No. 1" — Engel's
• State Budgetary Healthcare Institution of the Kaliningrad Region "City Hospital No. 2." — Kaliningrad
• Unimed-C Jsc — Moscow
• Professors' Clinic LLC. — Perm
• Limited Liability Company "Medical Center Eco-Safety" — Saint Petersburg
• Aurora MedFort LLC — Saint Petersburg
• St. Petersburg State Budgetary Healthcare Institution "City Polyclinic No. 117" — Saint Petersburg
• Limited Liability Company "Clinic Zvezdnaya" — Saint Petersburg
• … и ещё 4 центра

Идентификаторы

NCT: NCT06843018 · GRM-02-06-2024

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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