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

Last updated: February 27, 2025
Sponsor: Valenta Pharm JSC
Overall Status: Active - Recruiting

Phase

2

Condition

Common Cold

Pharyngitis

Treatment

Grammidin with anesthetic

Septolete Total

Clinical Study ID

NCT06843018
GRM-02-06-2024
  • Ages 18-75
  • All Genders

Study 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

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 (acutepharyngitis, acute nasopharyngitis, exacerbation of chronic pharyngitis) based onone or more of the following clinical manifestations:

  • Discomfort in the throat - symptoms of pharyngeal paresthesia (tickling in thethroat, dryness in the throat, scratchy throat (sensation of a "foreignbody"));

  • Pain in the throat (pain at rest, burning in the throat, pain when swallowingsaliva).

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

  2. A score of 5 to 8 points on the Clinical Symptom Severity Scale fortonsillopharyngitis.

  3. Absence of indications for systemic antibacterial therapy at the time of inclusionin the study.

  4. Negative test result for β-hemolytic streptococcus.

  5. Duration of disease symptoms not exceeding 3 days at the time of inclusion in thestudy.

  6. Women with a negative pregnancy test who have used one or more of the followingcontraceptive methods for 8 weeks prior to and during the 3 weeks after the end ofthe study: intrauterine devices (IUDs), oral contraceptives, contraceptive patches,long-acting injectable contraceptives, double barrier contraceptive method; or womenwho 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 conclusionor men who are infertile (documented conditions: vasectomy, infertility).

  7. Presence of a signed and dated informed consent from the patient to participate inthe study.

Non-inclusion Criteria:

  1. Trauma and/or burns of the oropharynx, scarlet fever, rubella, measles at the timeof inclusion in the study and not earlier than 3 months before inclusion in thestudy.

  2. Treatment with any systemic antibacterial agents within 14 days prior to inclusionin the study.

  3. Use of non-steroidal anti-inflammatory drugs and/or decongestants within 12 hoursprior to the randomization visit.

  4. Body temperature at screening and randomization visits ≥ 38.5 °C.

  5. Infectious-inflammatory diseases requiring combined or systemic antibacterialtherapy.

  6. Severe, decompensated, or unstable somatic diseases (any diseases or conditions thatthreaten the patient's life or worsen the prognosis of the underlying disease, aswell 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 recurredfor the last 5 years.

  8. Allergic history.

  9. Participation in any other clinical study within 90 days prior to inclusion in thestudy.

  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 frombeing included in the study.

Exclusion

Exclusion Criteria:

  1. Erroneous inclusion of a patient in the study (not meeting inclusion/exclusioncriteria at the time of randomization).

  2. Ineffectiveness of therapy. Therapy will be considered ineffective if there is noclinical improvement by Visit 2 (Day 3-4 of therapy) - persistence or worsening ofthe symptom "sore throat" and catarrhal phenomena compared to baseline data. Ifexcluded, the patient will be assigned alternative treatment at the discretion ofthe investigator.

  3. Patient non-compliance (a patient is considered compliant if the number ofapplications 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 thepatient.

  7. Pregnancy of the patient or necessity for breastfeeding.

  8. Gross violation by the patient of the study protocol procedures presented in thepatient information sheet (PIS).

  9. Withdrawal of informed consent (the patient's unwillingness to continueparticipation in the study).

  10. Loss of contact with the patient (inability to reach the patient by mobile and homephone (if applicable), as well as through a contact person; there must be at leastthree documented attempts to contact the patient).

  11. The emergence during the study of any diseases or conditions that worsen thepatient's prognosis and make it impossible for the patient to continue participatingin this clinical study.

  12. Any other reasons, including administrative ones, that in the investigator's opinionwould prevent the subject from completing the study.

Study Design

Total Participants: 300
Treatment Group(s): 2
Primary Treatment: Grammidin with anesthetic
Phase: 2
Study Start date:
November 14, 2024
Estimated Completion Date:
December 31, 2026

Connect with a study center

  • State autonomous health care institution "Engels City Clinical Hospital No. 1"

    Engels, 413116
    Russian Federation

    Active - Recruiting

  • State Budgetary Healthcare Institution of the Kaliningrad Region "City Hospital No. 2."

    Kaliningrad,
    Russian Federation

    Active - Recruiting

  • Unimed-C Jsc

    Moscow, 119571
    Russian Federation

    Active - Recruiting

  • Professors' Clinic LLC.

    Perm, 614070
    Russian Federation

    Active - Recruiting

  • Aurora MedFort LLC

    Saint Petersburg, 194156
    Russian Federation

    Active - Recruiting

  • LLC "Mariel Clinic"

    Saint Petersburg,
    Russian Federation

    Active - Recruiting

  • Limited Liability Company "Clinic Zvezdnaya"

    Saint Petersburg, 196158
    Russian Federation

    Active - Recruiting

  • Limited Liability Company "Meili"

    Saint Petersburg, 199406
    Russian Federation

    Active - Recruiting

  • St. Petersburg State Budgetary Healthcare Institution "City Polyclinic No. 117"

    Saint Petersburg, 194358
    Russian Federation

    Active - Recruiting

  • LLC "Center for DNA Research"

    Saratov,
    Russian Federation

    Active - Recruiting

  • Limited Liability Company "Medical Center Eco-Safety"

    St. Petersburg, 19119
    Russian Federation

    Active - Recruiting

  • LLC "Polyclinic Polimedika Veliky Novgorod"

    Veliky Novgorod,
    Russian Federation

    Active - Recruiting

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