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AzTrials

Pharyngitis AcutePhase 2NCT06843018

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

A Phase 2 study testing Grammidin with anesthetic and Septolete Total in people with Pharyngitis Acute and Pharyngitis, run by Valenta Pharm JSC at 12 sites in Russia.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Pharyngitis Acute, Pharyngitis, Nasopharyngitis
What is being tested?
Grammidin with anesthetic and Septolete Total
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
12 sitesRussia
Study dates
14 Nov 2024to 31 Dec 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 28Show fewer
  • 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.

Who cannot join

  • 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.
Show all 12Show fewer
  • 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.

Trial locations and contacts

12 sites in 1 country. Contact the study team or a site near you to ask about taking part.

12 sites in 1 country

Russia12 sites, 12 recruiting

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

    Engel's, 413116

    Ekaterina Muldagalieva, MD, +7 (8453) 51-59-02, katyfily@yandex.ru

    Recruiting

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

    Kaliningrad

    Valentina Glukhova, MD, +7-812-407-32-32, vgvalensia@yandex.ru

    Recruiting

  • Unimed-C Jsc

    Moscow, 119571

    Elena Volnaya, MD, +7-495-135-50-10, drvolnaya@yandex.ru

    Recruiting

  • Professors' Clinic LLC.

    Perm, 614070

    Svetlana Teplykh, MD, PhD, +7-342-206-25-74, profkliniki@mail.ru

    Recruiting

  • Limited Liability Company "Medical Center Eco-Safety"

    Saint Petersburg, 19119

    Vasiliy Vasilyuk, MD,PhD, Prof., +7 (812) 500-52-03 ext. 5001, vasilyuk_vb@ecosafety.ru

    Recruiting

  • Aurora MedFort LLC

    Saint Petersburg, 194156

    Igor Balaban, MD, +7-921-903-94-95, igorbalaban.81@mail.ru

    Recruiting

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

    Saint Petersburg, 194358

    Diana Alpenidze, MD,PhD, +7 (812) 246-73-10, d.alpenidze@mail.ru

    Recruiting

  • Limited Liability Company "Clinic Zvezdnaya"

    Saint Petersburg, 196158

    Dmitry Shkarbul, MD, +7 (812) 407-32-32, director@starsclinic.ru

    Recruiting

  • Limited Liability Company "Meili"

    Saint Petersburg, 199406

    Marina Leonteva, MD, +7-965-002-71-18, pileonteva@yandex.ru

    Recruiting

  • LLC "Mariel Clinic"

    Saint Petersburg

    Elena Poroshina, MD, PhD, +7-812-545-05-86, elporoshina@mail.ru

    Recruiting

  • LLC "Center for DNA Research"

    Saratov

    Inna Gamova, MD, PhD, +7-8452-49-43-14, innapris@yandex.ru

    Recruiting

  • LLC "Polyclinic Polimedika Veliky Novgorod"

    Velikiy Novgorod

    Olga Solovjova, MD, PhD, +7-812-303-50-00, o_solovjova@inbox.ru

    Recruiting

Other trials in Russia

About this study

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

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.

Being tested
Grammidin with anesthetic, Septolete Total
Medical subject headings
Pharyngitis, Nasopharyngitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Grammidin with anestheticDrug

    Also called gramicidine C + oxybuprocaine + cetylpyridine chloride

    Grammidin with anesthetic, a metered dose topical spray

  • Septolete TotalDrug

    Also called benzydamine + cetylpyridine chloride

    Septolete Total, lozenges 3 mg + 1 mg

Study groups in NCT06843018
Study groupRoleWhat they receive
Grammidin with anesthetic, 2 sprays every 6 hoursExperimentalPatients in group 1 will receive the drug Grammidin with anesthetic,a metered dose topical spray, with 2 sprays every 6 hours, three times a day under fed conditions for 7 days.
Receives: Drug: Grammidin with anesthetic
Grammidin with anesthetic, 4 sprays every 6 hoursExperimentalPatients in group 2 will receive the drug Grammidin with anesthetic, a metered dose topical spray, with 4 sprays every 6 hours, three times a day under fed conditions for 7 days.
Receives: Drug: Grammidin with anesthetic
Septolete Total, 1 lozenge every 6 hoursActive comparatorPatients in group 3 will receive the drug Septolete Total, lozenges 3 mg + 1 mg, 1 lozenge every 6 hours, three times daily (maximum daily dose - 3 lozenges) for 7 days.
Receives: Drug: Septolete Total

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Combined primary efficacy endpoint: VAS + TPA

    The primary efficacy endpoint will consist of two components:

    Change in sore throat severity as measured by the Visual Analog Scale (VAS) one hour after the first administration of the drug (STPID1h). In accordance to VAS, 0 mm - no pain, while 100 mm is the worst pain ever.

    Change in the severity of clinical symptoms according to the Tonsillopharyngitis Assessment Scale (TPA) at Visit 3 (or at the time of complete recovery and treatment completion if it occurs earlier). In accordance to TPA, each symptom is assessed from 0 points (absence or weak symptom) to 2 points (strong symptom).

    Measured: Day 1 (Visit 1) - Day 8 (Visit 3)

Secondary outcomes (51)

  1. Change in sore throat severity, 30 min

    Change in sore throat severity as measured by the Visual Analog Scale (VAS) 30 minutes after the first administration of the drug. In accordance to VAS, 0 mm - no pain, while 100 mm is the worst pain ever.

    Measured: Day 1 (Visit 1)

  2. Change in sore throat severity, Visits 2 and 3

    Change in sore throat severity as measured by the VAS at Visits 2 and 3. In accordance to VAS, 0 mm - no pain, while 100 mm is the worst pain ever.

    Measured: Day 5 (Visit 2), Day 8 (Visit 3)

  3. Change in the severity of clinical symptom

    Change in the severity of clinical symptoms according to the Tonsillopharyngitis Assessment Scale at Visit 2. In accordance to TPA, each symptom is assessed from 0 points (absence or weak symptom) to 2 points (strong symptom).

    Measured: Day 5 (Visit 2)

  4. Proportion of patients with no erythema and edema of the pharyngeal mucosa

    Proportion of patients with no erythema and edema of the pharyngeal mucosa according to the Erythema and Edema subscale of the Tonsillopharyngitis Clinical Symptom Severity Scale at Visits 2 and 3.

    Measured: Day 5 (Visit 2), Day 8 (Visit 3)

  5. Proportion of patients with no erythema and edema of the tonsils

    Proportion of patients with no erythema and edema of the tonsils according to the Erythema and Edema subscale of the Tonsillopharyngitis Clinical Symptom Severity Scale at Visits 2 and 3.

    Measured: Day 5 (Visit 2), Day 8 (Visit 3)

  6. Proportion of patients without signs of intoxication syndrome

    Proportion of patients without signs of intoxication syndrome, assessed using a 4-point scale at Visits 2 and 3.

    Measured: Day 5 (Visit 2), Day 8 (Visit 3)

  7. Overall frequency of adverse events

    Overall frequency of adverse events (AEs) (number of patients with at least one AE reported)

    Measured: Screening, Day 1 (Visit 1) to Day 8 (Visit 3)

  8. Number of adverse events

    Number of AEs stratified by severity and frequency

    Measured: Screening, Day 1 (Visit 1) to Day 8 (Visit 3)

  9. Frequency of drug-related adverse events

    Frequency of AEs related to the use of the study drug/comparison drug

    Measured: Day 1 (Visit 1) to Day 8 (Visit 3)

  10. Frequency of drug-related serious adverse events

    Frequency of serious adverse events (SAEs) related to the use of the study drug/comparison drug

    Measured: Day 1 (Visit 1) to Day 8 (Visit 3)

  11. Proportion of patients discontinued due to adverse events

    Proportion of patients who discontinued treatment due to AEs

    Measured: Day 1 (Visit 1) to Day 8 (Visit 3)

  12. Vital signs: systolic blood pressure

    Systolic blood pressure (SBP, mmHg)

    Measured: Screening, Day 1 (Visit 1), Day 5 (Visit 2), Day 8 (Visit 3)

  13. Vital signs: diastolic blood pressure

    Diastolic blood pressure (DBP, mmHg)

    Measured: Screening, Day 1 (Visit 1), Day 5 (Visit 2), Day 8 (Visit 3)

  14. Vital signs: heart rate

    Heart rate (HR, bpm)

    Measured: Screening, Day 1 (Visit 1), Day 5 (Visit 2), Day 8 (Visit 3)

  15. Vital signs: body temperature (Celsius temperature scale)

    Body temperature (Celsius temperature scale)

    Measured: Screening, Day 1 (Visit 1), Day 5 (Visit 2), Day 8 (Visit 3)

  16. Physical examination results: cardiovascular system

    An assessment of the condition of the cardiovascular system on physical examination (normal condition or list of abnormal conditions, if any)

    Measured: Screening, Day 1 (Visit 1), Day 5 (Visit 2), Day 8 (Visit 3)

  17. Physical examination results: respiratory system

    An assessment of the condition of the respiratory system on physical examination (normal condition or list of abnormal conditions, if any)(normal condition or list of abnormal conditions, if any)

    Measured: Screening, Day 1 (Visit 1), Day 5 (Visit 2), Day 8 (Visit 3)

  18. Physical examination results: digestive tract

    An assessment of the condition of the digestive tract on physical examination (normal condition or list of abnormal conditions, if any)

    Measured: Screening, Day 1 (Visit 1), Day 5 (Visit 2), Day 8 (Visit 3)

  19. Physical examination results: endocrine system

    An assessment of the condition of the endocrine system on physical examination (normal condition or list of abnormal conditions, if any)

    Measured: Screening, Day 1 (Visit 1), Day 5 (Visit 2), Day 8 (Visit 3)

  20. Physical examination results: musculoskeletal system

    An assessment of the condition of the musculoskeletal system on physical examination (normal condition or list of abnormal conditions, if any)

    Measured: Screening, Day 1 (Visit 1), Day 5 (Visit 2), Day 8 (Visit 3)

  21. Physical examination results: nervous system

    An assessment of the condition of the nervous system on physical examination (normal condition or list of abnormal conditions, if any)

    Measured: Screening, Day 1 (Visit 1), Day 5 (Visit 2), Day 8 (Visit 3)

  22. Physical examination results: sensory systems

    An assessment of the condition of the sensory systems on physical examination (normal condition or list of abnormal conditions, if any)

    Measured: Screening, Day 1 (Visit 1), Day 5 (Visit 2), Day 8 (Visit 3)

  23. Physical examination results: skin/visible mucous membranes

    An assessment of the condition of the skin/visible mucous membranes on physical examination (normal condition or list of abnormal conditions, if any)

    Measured: Screening, Day 1 (Visit 1), Day 5 (Visit 2), Day 8 (Visit 3)

  24. Results of laboratory and instrumental examinations: clinical blood test - hemoglobin

    Hemoglobin (g/L)

    Measured: Screening, Day 8 (Visit 3)

  25. Results of laboratory and instrumental examinations: clinical blood test - hematocrit

    Hematocrit (%)

    Measured: Screening, Day 8 (Visit 3)

  26. Results of laboratory and instrumental examinations: clinical blood test - red blood cell count

    Red blood cell count (cells/L)

    Measured: Screening, Day 8 (Visit 3)

  27. Results of laboratory and instrumental examinations: clinical blood test - platelet count

    Platelet count (cells/L)

    Measured: Screening, Day 8 (Visit 3)

  28. Results of laboratory and instrumental examinations: clinical blood test - leukocyte count

    Leukocyte count (cells/L)

    Measured: Screening, Day 8 (Visit 3)

  29. Results of laboratory and instrumental examinations: clinical blood test - erythrocyte sedimentation rate

    Erythrocyte sedimentation rate (mm/h)

    Measured: Screening, Day 8 (Visit 3)

  30. Results of laboratory and instrumental examinations: clinical blood test - myelocytes

    Leukocyte formula (myelocytes, %)

    Measured: Screening, Day 8 (Visit 3)

  31. Results of laboratory and instrumental examinations: clinical blood test - band neutrophils

    Leukocyte formula (band neutrophils, %)

    Measured: Screening, Day 8 (Visit 3)

  32. Results of laboratory and instrumental examinations: clinical blood test - segmented neutrophils

    Leukocyte formula (segmented neutrophils, %)

    Measured: Screening, Day 8 (Visit 3)

  33. Results of laboratory and instrumental examinations: clinical blood test - eosinophils

    Leukocyte formula (eosinophils, %)

    Measured: Screening, Day 8 (Visit 3)

  34. Results of laboratory and instrumental examinations: clinical blood test - basophils

    Leukocyte formula (basophils, %)

    Measured: Screening, Day 8 (Visit 3)

  35. Results of laboratory and instrumental examinations: clinical blood test - monocytes

    Leukocyte formula (monocytes, %)

    Measured: Screening, Day 8 (Visit 3)

  36. Results of laboratory and instrumental examinations: clinical blood test - lymphocytes

    Leukocyte formula (lymphocytes, %)

    Measured: Screening, Day 8 (Visit 3)

  37. Results of laboratory and instrumental examinations: blood chemistry - glucose

    Glucose concentration (mmol/L)

    Measured: Screening, Day 8 (Visit 3)

  38. Results of laboratory and instrumental examinations: blood chemistry - cholesterol

    Total cholesterol concentration (mmol/L)

    Measured: Screening, Day 8 (Visit 3)

  39. Results of laboratory and instrumental examinations: blood chemistry - protein

    Total protein concentration (g/L)

    Measured: Screening, Day 8 (Visit 3)

  40. Results of laboratory and instrumental examinations: blood chemistry - bilirubin

    Total bilirubin concentration (micromol/L)

    Measured: Screening, Day 8 (Visit 3)

  41. Results of laboratory and instrumental examinations: blood chemistry - creatinine

    Creatinine concentration (micromol/L)

    Measured: Screening, Day 8 (Visit 3)

  42. Results of laboratory and instrumental examinations: blood chemistry - alkaline phosphatase

    Alkaline phosphatase activity (U/L)

    Measured: Screening, Day 8 (Visit 3)

  43. Results of laboratory and instrumental examinations: blood chemistry - alanine transaminase

    Alanine transaminase activity (U/L)

    Measured: Screening, Day 8 (Visit 3)

  44. Results of laboratory and instrumental examinations: blood chemistry - aspartate transaminase

    Aspartate transaminase activity (U/L)

    Measured: Screening, Day 8 (Visit 3)

  45. Results of laboratory and instrumental examinations: urinalysis - specific gravity

    Specific gravity of the urine

    Measured: Screening, Day 8 (Visit 3)

  46. Results of laboratory and instrumental examinations: urinalysis - pH

    pH of the urine

    Measured: Screening, Day 8 (Visit 3)

  47. Results of laboratory and instrumental examinations: urinalysis - protein

    Protein concentration (g/L)

    Measured: Screening, Day 8 (Visit 3)

  48. Results of laboratory and instrumental examinations: urinalysis - glucose

    Glucose concentration (mmol/L)

    Measured: Screening, Day 8 (Visit 3)

  49. Results of laboratory and instrumental examinations: urinalysis - red blood cells

    Red blood cell content (number in sight)

    Measured: Screening, Day 8 (Visit 3)

  50. Results of laboratory and instrumental examinations: urinalysis - white blood cells

    White blood cell content (number in sight)

    Measured: Screening, Day 8 (Visit 3)

  51. Results of laboratory and instrumental examinations: blood chemistry - glomerular filtration rate

    Glomerular filtration rate calculated using blood creatinine levels and formula CKD-EPI

    Measured: Screening, Day 8 (Visit 3)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Feb 2025
  2. Study start14 Nov 2024
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06843018
Sponsor's protocol ID
GRM-02-06-2024
Status last verified
Jul 2025
First submitted
17 Feb 2025
Last updated
10 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Grammidin with anesthetic and Septolete Total in people with Pharyngitis Acute and Pharyngitis, run by Valenta Pharm JSC at 12 sites in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 28 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 10 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Combined primary efficacy endpoint: VAS + TPA (time frame: Day 1 (Visit 1) - Day 8 (Visit 3)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06843018.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2025.

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