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

NCT06843018 | Recruiting Phase 2

• 1 other identifier: GRM-02-06-2024
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 12

Brief 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.

Conditions

Pharyngitis Acute; Pharyngitis; Nasopharyngitis; Exacerbation of Chronic Pharyngitis

Outcome Measures

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).

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

Secondary Outcomes (51)

• Change in sore throat severity, 30 min

  Day 1 (Visit 1)

• Change in sore throat severity, Visits 2 and 3

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

• Change in the severity of clinical symptom

  Day 5 (Visit 2)

• Proportion of patients with no erythema and edema of the pharyngeal mucosa

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

• Proportion of patients with no erythema and edema of the tonsils

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

Study Arms (3)

Grammidin with anesthetic, 2 sprays every 6 hours

EXPERIMENTAL

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

Grammidin with anesthetic, 4 sprays every 6 hours

EXPERIMENTAL

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

Septolete Total, 1 lozenge every 6 hours

ACTIVE COMPARATOR

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

Grammidin with anesthetic DRUG

Grammidin with anesthetic, a metered dose topical spray

Also known as: gramicidine C + oxybuprocaine + cetylpyridine chloride

Grammidin with anesthetic, 2 sprays every 6 hours; Grammidin with anesthetic, 4 sprays every 6 hours

Septolete Total DRUG

Septolete Total, lozenges 3 mg + 1 mg

Also known as: benzydamine + cetylpyridine chloride

Septolete Total, 1 lozenge every 6 hours

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Negative test result for β-hemolytic streptococcus.
• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Valenta Pharm JSC: lead

Study Sites (12)

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

Engel's, 413116, Russia

RECRUITING

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

Kaliningrad, Russia

RECRUITING

Unimed-C Jsc

Moscow, 119571, Russia

RECRUITING

Professors' Clinic LLC.

Perm, 614070, Russia

RECRUITING

Limited Liability Company "Medical Center Eco-Safety"

Saint Petersburg, 19119, Russia

RECRUITING

Aurora MedFort LLC

Saint Petersburg, 194156, Russia

RECRUITING

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

Saint Petersburg, 194358, Russia

RECRUITING

Limited Liability Company "Clinic Zvezdnaya"

Saint Petersburg, 196158, Russia

RECRUITING

Limited Liability Company "Meili"

Saint Petersburg, 199406, Russia

RECRUITING

LLC "Mariel Clinic"

Saint Petersburg, Russia

RECRUITING

LLC "Center for DNA Research"

Saratov, Russia

RECRUITING

LLC "Polyclinic Polimedika Veliky Novgorod"

Veliky Novgorod, Russia

RECRUITING

MeSH Terms

Conditions

Pharyngitis; Nasopharyngitis

Interventions

Anesthetics; benoxinate; Benzydamine

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Nasopharyngeal Diseases

Intervention Hierarchy (Ancestors)

Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses; Indazoles; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2025
• First Posted: February 24, 2025
• Study Start: November 14, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 10, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

RU (12)