The Efficacy and Safety of Raphamin in the Treatment of Acute Rhinosinusitis in Adult Patients
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorMateria Medica Holding
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male and female aged 18 - 75 years.
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.
Disqualifiers
fever of ≥ 38.0°C;
the second wave of ARS symptoms;
one-sided process;
facial pain/pressure of 3 points (on the MSS scale).
Trial design
Design model
Parallel
Treatments tested in this trial
Raphamin
DrugOral administration
Placebo
DrugOral administration
Treatment groups
552 Participants
are divided into 2 treatment groupsGroup A: RaphaminExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
On 4 daySecondary outcomes
1
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.
Time frame
On 7 day of observation2
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.
Time frame
On days 1, 4 and 73
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).
Time frame
From day 1 to day 144
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.
Time frame
On days 1, 4 and 7Sponsors and contacts
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Source ClinicalTrials.gov