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Tests treatment safety and results for Rhinosinusitis
Official title The Efficacy and Safety of Raphamin in the Treatment of Acute Rhinosinusitis in Adult Patients
ClinicalTrials.gov ID: NCT06901297
What this study is testing
What is Raphamin?
Raphamin is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for rhinosinusitis.
Also referred to as MMH-407.
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
- Multicenter double-blind placebo-controlled randomized in parallel groups clinical trial of the efficacy and safety of Raphamin in the treatment of acute rhinosinusitis in adult patients.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
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 and female aged 18 - 75 years.
- Diagnosis of acute rhinosinusitis:
- 8-12 points on MSS scale;
- no more than 3 severe symptoms (3 points on the MSS scale)
- facial pain/heaviness in the facial area 1-2 points on the MSS scale.
You likely can't join if
- Symptoms of acute bacterial rhinosinusitis (three or more of those below):
- fever of ≥ 38.0°C;
- the second wave of ARS symptoms;
- one-sided process;
- facial pain/pressure of 3 points (on the MSS scale).
- Recurrent ARS (≥4 episodes of ARS per year with complete resolution of symptoms between episodes).
See the full eligibility criteria
- Male and female aged 18 - 75 years.
- Diagnosis of acute rhinosinusitis:
- 8-12 points on MSS scale;
- no more than 3 severe symptoms (3 points on the MSS scale)
- facial pain/heaviness in the facial area 1-2 points on the MSS scale.
- Disease duration up to 48 hours (from the onset of the first symptoms of the disease).
- Availability of a patient information sheet and an informed consent form for participation in the clinical trial signed by the patient.
- Patients who agreed to use a reliable method of contraception during the study (for men and women of reproductive potential).
- Symptoms of acute bacterial rhinosinusitis (three or more of those below):
- fever of ≥ 38.0°C;
- the second wave of ARS symptoms;
- one-sided process;
- facial pain/pressure of 3 points (on the MSS scale).
- Recurrent ARS (≥4 episodes of ARS per year with complete resolution of symptoms between episodes).
- Odontogenic rhinosinusitis.
- Allergic (seasonal or year-round) rhinitis.
- Nasal polyps or clinically significant nasal septum deviation.
- Concomitant otitis.
- Use of intranasal or systemic corticosteroids for 30 days prior to the screening visit.
- Use of intranasal or systemic antibiotics for 30 days prior to the screening visit.
- Surgery for the nasal cavity and paranasal sinuses during the last 6 months before the screening visit.
- Any other surgery during the last 3 months.
- Clinical symptoms of severe influenza/ARVI requiring hospitalization.
- Suspected bacterial infection of any localization requiring the administration of antibiotics from the first day of disease.
- History/suspicion of oncology of any localization (except for benign neoplasms).
- Exacerbation or decompensation of chronic diseases (diabetes mellitus, bronchial asthma, chronic bronchitis, chronic obstructive pulmonary disease, cystic fibrosis, primary ciliary dyskinesia, bronchopulmonary...
- Previously diagnosed immunodeficiency of any etiology.
- Unstable angina or myocardial infarction during the last 6 months.
- Class III and IV chronic heart failure (according to the classification of the New York Heart Association, 1964).
- History of chronic kidney disease (classes C3-5 A3).
- History of liver failure (class C according to Child-Pugh).
- Malabsorption syndrome, including congenital or acquired lactase or other disaccharidase deficiency, galactosemia.
- Pregnancy, breast-feeding, and childbirth less than 3 months before inclusion in the trial.
- Hypersensitivity to any component of the medicines used in the treatment.
- Patients who used medications listed under "Prohibited Concomitant Treatment" within 1 month prior to inclusion in the trial or need medications prohibited for use in the trial.
- Patients who, from the investigator's point of view, will not comply with the observation requirements during the trial or follow the procedure for taking the test drugs.
- History of mental illness, alcoholism, drug abuse, which, from the investigator's point of view, will prevent the patient from following the trial procedures.
- Participation in other clinical trials within 3 months prior to inclusion in this trial.
- Patient is related to on-site research personnel directly involved in the trial, or is the immediate family member of the investigator. 'Immediate family members' mean spouses, parents, children, or siblings, whether...
- Patient is employed by OOO "NPF "MATERIA MEDICA HOLDING", i.e., is an employee of the company, a temporary contract employee, or a designated official responsible for conducting the trial or their immediate family...
The study team makes the final eligibility decision.
Where it's taking place
- Aramil, Russia
- Gatchina, Russia
- Kaliningrad, Russia
- Kazan', Russia
- Krasnodar, Russia
- Moscow, Russia
- Nizhny Novgorod, Russia
- Novosibirsk, Russia
- Penza, Russia
- Perm, Russia
- Pyatigorsk, Russia
- Rostov-on-Don, Russia
- Saint Petersburg, Russia
- Samara, Russia
- Saratov, Russia
- Smolensk, Russia
- Stavropol, Russia
- Ufa, Russia
- Ulyanovsk, Russia
- Yaroslavl, Russia
+ 1 more site(s).
Compensation & support
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 Aramil, Russia; Gatchina, Russia; Kaliningrad, Russia; Kazan', Russia; Krasnodar, Russia; Moscow, Russia and 15 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.