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RecruitingNCT06843018Updated Jul 10, 2025

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 interventional study of Grammidin with anesthetic and Septolete Total in Pharyngitis Acute, Pharyngitis and Nasopharyngitis, sponsored by Valenta Pharm JSC. Recruiting at 12 sites in Russia. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-07-10.

Sponsored by Valenta Pharm JSC · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Nov 2024, registered Feb 2025).
  • Started Nov 2024; still recruiting 1 year 11 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Pharyngitis Acute
  • Pharyngitis
  • Nasopharyngitis
  • Exacerbation of Chronic Pharyngitis

Browse trials for

03

In context

Pharyngitis

226 studies on the registry are indexed under Pharyngitis; 35 are open to participants now.

This study's planned enrollment of 300 is above the median of 144 across 188 interventional studies indexed under Pharyngitis.

Browse Pharyngitis studies →

Lead sponsor

Valenta Pharm JSC is the lead sponsor of 40 studies on the registry; 18 are open to participants now.

Browse Valenta Pharm JSC studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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 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 , 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

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 (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.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
300 participants (estimated)

Study arms

  • Experimental
    Grammidin with anesthetic, 2 sprays every 6 hours

    Patients 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.

    Drug: Grammidin with anesthetic

  • Experimental
    Grammidin with anesthetic, 4 sprays every 6 hours

    Patients 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.

    Drug: Grammidin with anesthetic

  • Active comparator
    Septolete Total, 1 lozenge every 6 hours

    Patients 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.

    Drug: Septolete Total

Interventions

  • DrugGrammidin with anesthetic

    Grammidin with anesthetic, a metered dose topical spray

    Also known as: gramicidine C + oxybuprocaine + cetylpyridine chloride

  • DrugSeptolete Total

    Septolete Total, lozenges 3 mg + 1 mg

    Also known as: benzydamine + cetylpyridine chloride

06

What researchers measure

Primary outcomes

  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).

    Time frame: Day 1 (Visit 1) - Day 8 (Visit 3)

Secondary outcomes

  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.

    Time frame: 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.

    Time frame: 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).

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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)

    Time frame: Screening, Day 1 (Visit 1) to Day 8 (Visit 3)

  8. Number of adverse events

    Number of AEs stratified by severity and frequency

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: Day 1 (Visit 1) to Day 8 (Visit 3)

  12. Vital signs: systolic blood pressure

    Systolic blood pressure (SBP, mmHg)

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

  13. Vital signs: diastolic blood pressure

    Diastolic blood pressure (DBP, mmHg)

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

  14. Vital signs: heart rate

    Heart rate (HR, bpm)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: Screening, Day 8 (Visit 3)

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

    Hematocrit (%)

    Time frame: 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)

    Time frame: Screening, Day 8 (Visit 3)

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

    Platelet count (cells/L)

    Time frame: Screening, Day 8 (Visit 3)

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

    Leukocyte count (cells/L)

    Time frame: Screening, Day 8 (Visit 3)

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

    Erythrocyte sedimentation rate (mm/h)

    Time frame: Screening, Day 8 (Visit 3)

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

    Leukocyte formula (myelocytes, %)

    Time frame: Screening, Day 8 (Visit 3)

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

    Leukocyte formula (band neutrophils, %)

    Time frame: Screening, Day 8 (Visit 3)

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

    Leukocyte formula (segmented neutrophils, %)

    Time frame: Screening, Day 8 (Visit 3)

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

    Leukocyte formula (eosinophils, %)

    Time frame: Screening, Day 8 (Visit 3)

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

    Leukocyte formula (basophils, %)

    Time frame: Screening, Day 8 (Visit 3)

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

    Leukocyte formula (monocytes, %)

    Time frame: Screening, Day 8 (Visit 3)

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

    Leukocyte formula (lymphocytes, %)

    Time frame: Screening, Day 8 (Visit 3)

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

    Glucose concentration (mmol/L)

    Time frame: Screening, Day 8 (Visit 3)

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

    Total cholesterol concentration (mmol/L)

    Time frame: Screening, Day 8 (Visit 3)

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

    Total protein concentration (g/L)

    Time frame: Screening, Day 8 (Visit 3)

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

    Total bilirubin concentration (micromol/L)

    Time frame: Screening, Day 8 (Visit 3)

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

    Creatinine concentration (micromol/L)

    Time frame: Screening, Day 8 (Visit 3)

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

    Alkaline phosphatase activity (U/L)

    Time frame: Screening, Day 8 (Visit 3)

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

    Alanine transaminase activity (U/L)

    Time frame: Screening, Day 8 (Visit 3)

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

    Aspartate transaminase activity (U/L)

    Time frame: Screening, Day 8 (Visit 3)

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

    Specific gravity of the urine

    Time frame: Screening, Day 8 (Visit 3)

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

    pH of the urine

    Time frame: Screening, Day 8 (Visit 3)

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

    Protein concentration (g/L)

    Time frame: Screening, Day 8 (Visit 3)

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

    Glucose concentration (mmol/L)

    Time frame: Screening, Day 8 (Visit 3)

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

    Red blood cell content (number in sight)

    Time frame: Screening, Day 8 (Visit 3)

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

    White blood cell content (number in sight)

    Time frame: 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

    Time frame: Screening, Day 8 (Visit 3)

07

Study locations

12 of 12 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Nov 2024 (actual). Primary completion is estimated for Dec 2026, 25 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 17, 2025
First posted
Feb 24, 2025
StartActual
Nov 14, 2024
Primary completionEst.
Dec 31, 2026
CompletionEst.
Dec 31, 2026
Last update
Jul 10, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 10, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06843018
Lead sponsor
Valenta Pharm JSC
Responsible party
Sponsor
First posted
Feb 24, 2025
Start date
Nov 14, 2024
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Jul 10, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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