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Compares treatment options for Pharyngitis Acute
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
ClinicalTrials.gov ID: NCT06843018
What this study is testing
What is Grammidin with anesthetic?
Grammidin with anesthetic is an investigational medicine, given as a treatment applied to the skin, being studied as a potential treatment for pharyngitis acute.
Also referred to as gramicidine C + oxybuprocaine + cetylpyridine chloride.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join 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...
- Unpleasant sensations/discomfort in the throat - symptoms of pharyngeal paresthesia (scratchy throat, dryness or sore sensation ("foreign body"...
- 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).
You likely can't join if
- 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...
- 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...
- 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.
See the full eligibility criteria
- 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.
- 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...
- Signed and dated informed consent form. Non-
- 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...
- History of malignancy, exept for people 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Engel's, Russia
- Kaliningrad, Russia
- Moscow, Russia
- Perm, Russia
- Saint Petersburg, Russia
- Saratov, Russia
- Veliky Novgorod, Russia
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Engel's, Russia; Kaliningrad, Russia; Moscow, Russia; Perm, Russia; Saint Petersburg, Russia; Saratov, Russia and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.