RhinosinusitisPhase 3NCT06901297
The Efficacy and Safety of Raphamin in the Treatment of Acute Rhinosinusitis in Adult Patients
A Phase 3 study testing Raphamin in people with Rhinosinusitis and Rhinosinusitis Acute, run by Materia Medica Holding at 44 sites in Russia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rhinosinusitis, Rhinosinusitis Acute
- What is being tested?
- Raphamin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 552 participants
- Where
- 44 sitesRussia
- Study dates
- 3 Apr 2025to 31 Dec 2027
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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).
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- 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 dysplasia, malformations of the respiratory and ENT organs, etc.) affecting the patient's ability to participate in the clinical trial.
- 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 related or adopted.
- 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 member.
Trial locations and contacts
44 sites in 1 country. Contact the study team or a site near you to ask about taking part.
44 sites in 1 country
Russia44 sites, 7 recruiting
- Active, not recruiting
Aramil city hospital
Aramil, 624002
- Completed
Gatchina Clinical Interdistrict Hospital
Gatchina
- Recruiting
Baltic Federal University named after Immanuel Kant
Kaliningrad, 236016
Ekaterina Andreeva, MD, PhD
Ekaterina Andreeva, MD, PhD
- Completed
Kazan State Medical University/Department of Infectious Diseases
Kazan', 420012
- Terminated
Kuban State Medical University/Department of Infectious Diseases and Phthisiopulmonology
Krasnodar, 350063
- Recruiting
City Polyclinic # 2 of the Moscow City Department of Health
Moscow, 117556
Margarita Dorofeeva, MD, PhD
Margarita Dorofeeva, MD, PhD
- Completed
First Moscow State Medical University named after I.M. Sechenov/Department of Ear, Nose and Throat Diseases
Moscow, 119991
- Recruiting
National Medical Research Center of Otolaryngology
Moscow, 123182
Olga Karneeva, MD, PhD
Olga Karneeva, MD, PhD
- Completed
Russian University of Medicine/Department of Otolaryngology
Moscow, 127006
- Active, not recruiting
Moscow Regional Research Clinical Institute named after M.F. Vladimirsky
Moscow, 129110
- Completed
LLC "Persona Group of Companies"
Nizhny Novgorod, 603155
- Completed
Novosibirsk State Medical University/Department of Otolaryngology
Novosibirsk, 630091
- Not yet recruiting
LLC "Clinical and Diagnostic Center "Mediclinic"
Penza, 440071
Natalia Pochinina, MD, PhD
Natalia Pochinina, MD, PhD
- Completed
LLC "Professor's Clinic"
Perm, 614070
- Not yet recruiting
LLC "4D Ultrasound Clinic"
Pyatigorsk, 357502
Tatyana Rushnichenko, MD
Tatyana Rushnichenko, MD
- Completed
Rostov Central District Hospital
Rostov-on-Don, 152155
- Active, not recruiting
LLC "Otolaryngology Consultation Center"
Rostov-on-Don, 344000
- Active, not recruiting
Rostov-on-Don City Hospital of Emergency Medical Care
Rostov-on-Don, 344068
- Active, not recruiting
North-West State Medical University named after I.I. Mechnikov/Department of Otolaryngology
Saint Petersburg, 191015
- Active, not recruiting
St. Petersburg Research Institute of Phthisiopulmonology
Saint Petersburg, 191036
- Completed
City Polyclinic # 44
Saint Petersburg, 192071
- Active, not recruiting
City Polyclinic # 109
Saint Petersburg, 192283
- Completed
LLC "Energy of Health"
Saint Petersburg, 194156
- Completed
LLC "Medical center "Reavita Med SPb"
Saint Petersburg, 194354
- Active, not recruiting
LLC "Medical services"
Saint Petersburg, 194356
- Not yet recruiting
LLC "Our Health"
Saint Petersburg, 195272
Elena Shcherbakova, MD, PhD
Elena Shcherbakova, MD, PhD
- Completed
LLC "Zvezdnaya Clinic"
Saint Petersburg, 196158
- Completed
First Saint Petersburg State Medical University named after I.P. Pavlov/Department of Otolaryngology with clinic
Saint Petersburg, 197022
- Completed
City Polyclinic # 34
Saint Petersburg, 197198
- Completed
Institute of Experimental Medicine
Saint Petersburg, 197376
- Completed
City Polyclinic # 106
Saint Petersburg, 198328
- Active, not recruiting
City Pokrovskaya Hospital
Saint Petersburg, 199106
- Active, not recruiting
LLC "Meili"
Saint Petersburg, 199406
- Active, not recruiting
Medical University "Reaviz"
Samara, 443001
- Completed
Samara State Medical University/Department of Otolaryngology
Samara, 443099
- Active, not recruiting
Saratov State Medical University named after V.I. Razumovsky/Department of Faculty Therapy
Saratov, 410012
- Completed
LLC "Uromed"
Smolensk, 214031
- Active, not recruiting
LLC "Scientific Medical Center of General Therapy and Pharmacology"
Stavropol, 355000
- Completed
Bashkir State Medical University/Department of Internal Medicine
Ufa, 450008
- Completed
Ulyanovsk Regional Clinical Hospital
Ulyanovsk, 432017
- Active, not recruiting
LLC "Dr. Bogorodskaya's Clinic of Modern Medicine"
Yaroslavl, 150001
- Active, not recruiting
Clinical Hospital # 2
Yaroslavl, 150030
- Recruiting
LLC "Medical center for diagnostics and prevention plus"
Yaroslavl, 150040
Ekaterina Melnikova, MD, PhD
Ekaterina Melnikova, MD, PhD
- Withdrawn
Ural State Medical University/Department of Surgical Dentistry, Otorhinolaryngology and Maxillofacial Surgery
Yekaterinburg, 620028
About this study
Official title: Multicenter, Double-blind, Placebo-controlled, Randomized, Parallel-group Clinical Trial of the Efficacy and Safety of Raphamin in the Treatment of Acute Rhinosinusitis in Adult Patients
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.
Read the detailed description
A multicenter, double-blind, placebo-controlled, randomized, parallel-group clinical trial.
The trial will enroll outpatients of either gender aged 18 to 75 years with clinical manifestations of acute rhinosinusitis (ARS) within the first 48 hours after the disease onset. Patient recruitment will be conducted during the seasonal incidence of acute respiratory viral infection (ARVI). After the patient signs the information sheet and informed consent form for participation in the clinical trial, the medical history will be collected, thermometry, objective examination, laboratory tests will be performed, concomitant diseases and concomitant therapy will be recorded. The severity of ARS symptoms will be assessed using Major Symptom Score (MSS). Initially (Day 1) and on Visits 2 (Day 4) and 3 (Day 7), the patient together with the investigator, fills in the MSS scale and completes the Sino-Nasal Outcome Test questionnaire for assessing the quality of life of patients with diseases of the nose and paranasal sinuses (SNOT-22).
If all inclusion criteria are met and there no any exclusion criteria, at Visit 1 (Day 1), the patient is randomized into one of two groups: Group 1 patients will receive Raphamin according to the dosage regimen for 5 days; Group 2 patients will receive Placebo using the Raphamin dosage regimen for 5 days.
The trial uses an electronic patient diary (EPD) where the patient daily morning and evening will make records axillary body temperature (measured with a classic mercury-free thermometer) and symptoms of the disease (according to the MSS). In addition, administration of basic therapy drugs (if applicable) as well as any possible worsening of the patient's condition (if applicable, to assess safety / to record adverse events) should also be recorded in the patient diary. The investigator will instruct the patient on how to complete the diary. At Visit 1, the patient will record the severity of ARS symptoms and body temperature in the diary together with the physician.
The patient will be observed for 14 days (screening, randomization - up to 1 day, treatment - 5 days, follow-up - up to 14 days).
During the treatment and follow-up period, patients/physicians will pay 3 visits, on days 1, 4 and 7 (Visits 1, 2 and 3) - at a medical center or at home; a phone visit (Visit 4) will be on day 14.
At Visits 2 and 3, the investigator performs objective examination, records changes in the disease symptoms, concomitant therapy, and controls the filling of the diary, evaluates the patient's compliance (Visit 3). At Visit 4 (a phone visit), the investigator evaluates safety, collects information about the patient's condition, the presence/absence of complications, the use of antibiotics, and the presence/absence of hospitalization of the patient.
Symptomatic therapy and therapy for concomitant diseases will be permitted during the trial except for the drugs listed under "Prohibited Concomitant Treatment".
- Conditions
- Rhinosinusitis, Rhinosinusitis Acute
- Being tested
- Raphamin, Placebo
- Keywords
- Rhinosinusitis, Acute
- Medical subject headings
- Rhinosinusitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RaphaminDrug
Also called MMH-407
Oral administration
PlaceboDrug
Oral administration
| Study group | Role | What they receive |
|---|---|---|
| Raphamin | Experimental | Per os without food. The tablet should be kept in mouth until completely dissolved.
On day 1 of treatment, 8 tablets should be taken using the following regimen: 1 tablet every 30 minutes for the first 2 hours (5 tablets in total for 2 hours), then 1 more tablet 3 times at equal intervals during the same day. On day 2 and onwards, 1 tablet should be taken 3 times a day. The duration of treatment is 5 days. Receives: Drug: Raphamin |
| Placebo | Placebo comparator | Placebo using the Raphamin dosage regimen. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with improvement of acute rhinosinusitis symptoms on day 4
Improvement of symptoms is defined as symptom score less than or equal to 1 (i.e., mild symptoms or no symptoms) for all five main symptoms (rhinorrhea / anterior nasal discharge, postnasal drip, nasal congestion, headache, facial pain/pressure) with 2 consecutive 12-hour estimates.
Measured: On 4 day
Secondary outcomes (14)
Percentage of patients with improvement of acute rhinosinusitis symptoms on day 7
Improvement of symptoms is defined as symptom score less than or equal to 1 (i.e., mild symptoms or no symptoms) for all five main symptoms (rhinorrhea / anterior nasal discharge, postnasal drip, nasal congestion, headache, facial pain/pressure) with 2 consecutive 12-hour estimates.
Measured: On 7 day of observation
Change in SNOT-22 total score
Change in the Sino-Nasal Outcome Test (SNOT-22) total score from baseline to days 4 and 7 of observation. 22 symptoms are assessed. Symptom severity is rated on a scale of 0 to 5 (0 - no problem, 1 - very mild problem, 2 - mild or slight problem, 3 - moderate problem, 4 - severe problem, 5 - as bad as it gets). The maximum SNOT-22 score is 110.
Measured: On days 1, 4 and 7
Change in MSS total score
Based on patient dairy. Change in MSS total score daily from baseline to day 14 of observation. Five main symptoms are assessed: runny nose/anterior nasal discharge, postnasal drip (need to cough mucus from the throat), nasal congestion, headache, facial pain/heaviness). The severity of symptoms is assessed in points from 0 to 3 (0 - none, 1 - mild, 2 - moderate, 3 - severe). The maximum total MSS score is 15 points. The total MSS score should not be less than 8 and not more than 12 points (inclusion criterion).
Measured: From day 1 to day 14
Change in the SNOT-22 nasal domain score
Change in the SNOT-22 nasal domain score from baseline to days 4 and 7 of observation.
Measured: On days 1, 4 and 7
Percentage of patients with worsening of rhinosinusitis requiring systemic/topical antibiotics
Percentage of patients with worsening of rhinosinusitis requiring systemic/topical antibiotics. Based on medical records.
Measured: On 14 day
Proportion of patients hospitalized due to worsening rhinosinusitis
Proportion of patients hospitalized due to worsening rhinosinusitis. Based on medical records.
Measured: On 14 day
Percentage of patients with prolonged rhinosinusitis
The percentage of patients with prolonged rhinosinusitis (main symptoms of the disease persisting for more than 7 days, progression of symptoms). Prolonged rhinosinusitis is defined as the persistence of the main symptoms of the disease, the progression of symptoms for more than 7 days, namely, the presence of the MSS symptoms rated as 2 or more points for one or more symptoms.
Measured: On 14 day
Number of Participants With Adverse Events (AEs)
Presence and nature of adverse events during therapy. Registration of AEs begins after the first dose of the study drug, continues throughout the entire period of study therapy, and also for 24 hours after the last dose of the study drug. Based on medical records.
Measured: From day 1 to day 14
Severity of AEs
The intensity (severity) of adverse events. Based on medical records.
Measured: From day 1 to day 6
Causal Relationship of AEs to the Sudy Drug
The causal relationship to the study drug of adverse events. Based on medical records.
Measured: From day 1 to day 6
Outcome of AEs
The outcome of adverse events. Based on medical records.
Measured: From day 1 to day 6
Changes in Vital Signs (Blood Pressure)
Blood Pressure measured in mm Hg. Based on medical records.
Measured: On days 1, 4 and 7
Changes in Vital Signs (Heart Rate)
Pulse Rate measured in beats per minute. Based on medical records.
Measured: On days 1, 4 and 7
Changes in Vital Signs (Breathing Rate)
Respiratory Rate measured in breaths per minute. Based on medical records.
Measured: On days 1, 4 and 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2025
- Study start3 Apr 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RhinosinusitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blind, placebo-controlled, randomized, parallel-group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 552 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Materia Medica Holding
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06901297
- Sponsor's protocol ID
- MMH-407-011
- Status last verified
- Mar 2026
- First submitted
- 24 Mar 2025
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No