Clinical trial Recruiting at 12 sites Phase 2 Interventional Ages 18 to 75

Evaluating Graminidin with Anesthetic for Treating Sore Throat

Official title: 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

Run by Valenta Pharm JSC · NCT06843018 · Data updated 2026-11-12

This study is testing a new throat spray called Graminidin with anesthetic to see if it helps people with sore throats feel better compared to a popular throat lozenge.

Quick facts

PhasePhase 2
Study typeInterventional
Ages18 Years to 75 Years
SexAll
Enrollment300 (estimated)
SponsorValenta Pharm JSC
Industry-sponsored
Locations12 sites (Engel's and 11 other locations)
StatusRecruiting
StartedNovember 14, 2024
Main results expectedDecember 31, 2026
Study endsDecember 31, 2026
Registry record updatedJuly 10, 2025
Trial IDNCT06843018 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults aged 18 to 75 with recent onset sore throat symptoms due to pharyngeal infections.

Probably not a fit

Patients with severe throat infections requiring systemic antibacterial therapy or those with negative β-hemolytic streptococcus tests may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the efficacy and safety of different doses of Graminidin with anesthetic, a metered-dose spray, for treating acute infectious and inflammatory diseases of the pharynx, such as acute pharyngitis and exacerbation of chronic pharyngitis. Participants will be assessed based on their symptoms of sore throat, which must fall within specific severity ranges. The study compares the effects of Graminidin with those of Septolete Total lozenges. The goal is to determine the optimal dosing for effective symptom relief.

Why it matters

Potential benefit: If successful, this treatment could provide effective relief for patients suffering from acute throat infections.

How similar studies have gone: While similar treatments have been explored, this specific approach with Graminidin is relatively novel and has not been extensively tested.

Who can join: the full rules

Show full inclusion / exclusion 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:

   * 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;
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. Signed and dated informed consent form.

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 malignancy, exept for subjects who have been disease-free for at least 5 years prior to screening.
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 within 21 days prior to study enrollment.
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. Requirement for prohibited concomitant therapy.
6. The investigator determines that continued participation in the study may pose a risk to the subject's safety or well-being.
7. Pregnancy or 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 judgment would prevent the subject from completing the study.

Where it's running

  • State autonomous health care institution "Engels City Clinical Hospital No. 1"
    Engel's, Russia
    Recruiting
  • State Budgetary Healthcare Institution of the Kaliningrad Region "City Hospital No. 2."
    Kaliningrad, Russia
    Recruiting
  • Unimed-C Jsc
    Moscow, Russia
    Recruiting
  • Professors' Clinic LLC.
    Perm, Russia
    Recruiting
  • Limited Liability Company "Medical Center Eco-Safety"
    Saint Petersburg, Russia
    Recruiting
  • Aurora MedFort LLC
    Saint Petersburg, Russia
    Recruiting
Show 6 more locations
  • St. Petersburg State Budgetary Healthcare Institution "City Polyclinic No. 117"
    Saint Petersburg, Russia
    Recruiting
  • Limited Liability Company "Clinic Zvezdnaya"
    Saint Petersburg, Russia
    Recruiting
  • Limited Liability Company "Meili"
    Saint Petersburg, Russia
    Recruiting
  • LLC "Mariel Clinic"
    Saint Petersburg, Russia
    Recruiting
  • LLC "Center for DNA Research"
    Saratov, Russia
    Recruiting
  • LLC "Polyclinic Polimedika Veliky Novgorod"
    Velikiy Novgorod, Russia
    Recruiting

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.