Efficacy and Safety of XC8, Film-coated Tablets, in Children With Acute Respiratory Viral Infections (NCT06379542) | Clinical Trial Compass
UnknownPhase 3
Efficacy and Safety of XC8, Film-coated Tablets, in Children With Acute Respiratory Viral Infections
Russia252 participantsStarted 2023-12-04
Plain-language summary
The study is planned to evaluate the therapeutic efficacy and safety of XC8, film-coated tablets, in the treatment of dry non-productive cough on the background of acute respiratory infections in children from 6 to 17 years compared with placebo.
Who can participate
Age range6 Years – 17 Years
SexALL
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Inclusion criteria
✓. Patient signing the Informed Consent Form and parent/adoptive parent signing the Parent/Adoptive Informed Consent Form.
✓. Male and female children between the ages of 6 and 17 years 10 months inclusive at the time of screening.
✓. Clinical diagnosis of acute respiratory viral upper respiratory tract infection (J00-J06 according to ICD-10) or acute bronchitis (J20, J21 according to ICD-10).
✓. Onset of disease symptoms no more than 3 days prior to screening.
✓. Presence of dry non-productive cough in the patient.
✓. Frequency of cough attacks ≥10 in the last 24 h before the screening visit and randomization.
✓. Cough frequency rated by the patient (for patients 13-17 years of age) or parent/adoptive parent (for patients 6-12 years of age) as 3-4 points on the "daytime cough" section and 2-4 points on the "nighttime cough" Daytime and nighttime cough scales.
✓. Patient (for patients 13-17 years of age) or parent/adoptive parent (for patients 6-12 years of age) assessment of cough severity on the digital rating scale as ≥4 points.
Exclusion criteria
✕. Identification of a confirmed case of COVID-19.
✕. Ineffectiveness of therapy - persistence or increase in cough attack frequency ≥1 by Visit 3 (Day 8-9) compared to Visit 1 (Day 1).
✕. Adverse events (AEs) requiring withdrawal of study drug/placebo.
What they're measuring
1
Decrease in percentage of patients with ≥50% reduction in number of cough attacs by day 5 relative to day 1
Timeframe: Assessment will include data collected within 24 hours before day 1 and day 5
✕. Occurrence of any disease or condition during the study that, in the opinion of the investigator, worsens the patient's prognosis and makes it impossible for the patient to continue participating in the clinical trial.
✕. Erroneous inclusion of a patient who does not meet the inclusion criteria and/or meets the criteria for non-inclusion.
✕. Taking any of the drugs of prohibited therapy, performing a prohibited procedure.
✕. Need to prescribe a prohibited concomitant therapy/procedure.