Study to Evaluate the Efficacy and Safety of Different Doses of Graminidin With Anesthetic, a Met⦠(NCT06843018) | Clinical Trial Compass
RecruitingPhase 2
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
Russia300 participantsStarted 2024-11-14
Plain-language summary
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.
Who can participate
Age range18 Years β 75 Years
SexALL
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Inclusion criteria
β. Male or female patients aged 18 to 75 years inclusive.
β. 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:
β. Severity of the symptom "sore throat" from 55 mm to 80 mm on the Visual Analog Scale (VAS).
β. A score of 5 to 8 points on the Clinical Symptom Severity Scale for tonsillopharyngitis.
β. Absence of indications for systemic antibacterial therapy at the time of inclusion in the study.
β. Negative test result for Ξ²-hemolytic streptococcus.
β. Duration of disease symptoms not exceeding 3 days at the time of inclusion in the study.
β. 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).
Exclusion criteria
β. Erroneous inclusion of a patient in the study (not meeting inclusion/exclusion criteria at the time of randomization).
β. 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.
β. 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).
β. Smoking more than 10 cigarettes per day.
β. Requirement for prohibited concomitant therapy.
β. The investigator determines that continued participation in the study may pose a risk to the subject's safety or well-being.
β. Pregnancy or breastfeeding.
β. Gross violation by the patient of the study protocol procedures presented in the patient information sheet (PIS).