Actively Recruiting
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
Led by Valenta Pharm JSC · Updated on 2025-07-10
300
Participants Needed
12
Research Sites
111 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patients aged 18 to 75 years inclusive
- Sore throat symptoms due to infectious-inflammatory diseases of the pharynx including acute pharyngitis, acute nasopharyngitis, or exacerbation of chronic pharyngitis
- Sore throat severity between 55 mm and 80 mm on the Visual Analog Scale (VAS)
- Clinical Symptom Severity Scale score of 5 to 8 points for tonsillopharyngitis
- No indications for systemic antibacterial therapy at study entry
- Negative test for b2-hemolytic streptococcus
- Disease symptoms lasting no more than 3 days at study entry
- Women with negative pregnancy test using approved contraceptive methods during and after the study, or infertile women; men using double barrier contraception or infertile men
- Signed and dated informed consent form
You will not qualify if you...
- Trauma, burns of the oropharynx, scarlet fever, rubella, or measles within 3 months before study
- Use of systemic antibacterial agents within 14 days before study
- Use of NSAIDs or decongestants within 12 hours before randomization
- Body temperature e8.5 C at screening or randomization
- Infectious-inflammatory diseases requiring systemic antibacterial therapy
- Severe, unstable somatic diseases threatening life or study participation
- History of malignancy unless disease-free for at least 5 years
- History of allergies
- Participation in other clinical studies within 90 days
- Pregnancy or breastfeeding
- Refusal to use effective contraception during the study
- Alcoholism, drug addiction, or psychotropic medication abuse
- Smoking more than 10 cigarettes per day
- Positive urine test for narcotics or potent medications
- Vaccination within 21 days before enrollment
- Other conditions preventing study inclusion per investigator judgment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 12 locations
1
State autonomous health care institution "Engels City Clinical Hospital No. 1"
Engel's, Russia, 413116
Actively Recruiting
2
State Budgetary Healthcare Institution of the Kaliningrad Region "City Hospital No. 2."
Kaliningrad, Russia
Actively Recruiting
3
Unimed-C Jsc
Moscow, Russia, 119571
Actively Recruiting
4
Professors' Clinic LLC.
Perm, Russia, 614070
Actively Recruiting
5
Limited Liability Company "Medical Center Eco-Safety"
Saint Petersburg, Russia, 19119
Actively Recruiting
6
Aurora MedFort LLC
Saint Petersburg, Russia, 194156
Actively Recruiting
7
St. Petersburg State Budgetary Healthcare Institution "City Polyclinic No. 117"
Saint Petersburg, Russia, 194358
Actively Recruiting
8
Limited Liability Company "Clinic Zvezdnaya"
Saint Petersburg, Russia, 196158
Actively Recruiting
9
Limited Liability Company "Meili"
Saint Petersburg, Russia, 199406
Actively Recruiting
10
LLC "Mariel Clinic"
Saint Petersburg, Russia
Actively Recruiting
11
LLC "Center for DNA Research"
Saratov, Russia
Actively Recruiting
12
LLC "Polyclinic Polimedika Veliky Novgorod"
Veliky Novgorod, Russia
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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