nctId: NCT06379542 id: XC8-03-05-2023 briefTitle: Efficacy and Safety of XC8, Film-coated Tablets, in Children With Acute Respiratory Viral Infections overallStatus: RECRUITING date: 2023-12-04 date: 2025-12-31 date: 2025-12-31 date: 2024-04-23 date: 2024-04-23 name: Valenta Pharm JSC class: INDUSTRY briefSummary: 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. conditions: Acute Respiratory Infection studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 252 type: ESTIMATED name: XC8 name: Placebo measure: Decrease in percentage of patients with ≥50% reduction in number of cough attacs by day 5 relative to day 1 measure: Number of cough attacks by day 5, day 8, day 11 and day 15 measure: Time (days) from visit 1 until clinical cough cure is achieved measure: Proportion of patients with presence of ≤ 1 score for the "daytime cough" and "nighttime cough" sections Daytime and nighttime cough scales by days 5, 8, 11, and 15 after visit 1 measure: Change (score) in cough severity by digital rating scale by days 5, 8, 11 and 15 compared to visit 1 measure: Percentage of patients needed acetylcysteine measure: Proportion of patients with complete resolution of all symptoms of acute respiratory infection by days 4, 7, 10 and 14 measure: Percentage of patients with each category of Global Physician-Researcher Assessment of Therapy Effectiveness at visits 2, 3, 4, and 5 measure: Number of adverse events (AEs) measure: Adverse reactions measure: Serious adverse events (SAEs) measure: Percentage of patients with AEs measure: Percentage of patients who interrupted treatment sex: ALL minimumAge: 6 Years maximumAge: 17 Years stdAges: CHILD facility: City Pediatric Outpatient Clinic number 5 status: RECRUITING city: Perm zip: 614066 country: Russian Federation name: Olga Perminova, MD, PhD role: CONTACT phone: +7 (912) 882 0549 email: perminova20062006@yandex.ru lat: 58.01046 lon: 56.25017 facility: Professors' Clinic LLC. status: RECRUITING city: Perm zip: 614070 country: Russian Federation name: Svetlana Teplykh, MD, PhD role: CONTACT phone: +7 (919) 498 2931 email: profkliniki@mail.ru lat: 58.01046 lon: 56.25017 facility: St. Petersburg State Budgetary Healthcare Institution "City Polyclinic No. 44" status: RECRUITING city: Saint Petersburg zip: 192071 country: Russian Federation name: Olga V Trusova, MD,PhD role: CONTACT phone: +7 (812) 417-40-02 email: o-tru@mail.ru lat: 59.93863 lon: 30.31413 facility: ArsVite North-West, LLC status: RECRUITING city: Saint Petersburg zip: 194223 country: Russian Federation name: Svetlana G Lazareva, MD role: CONTACT phone: +7-812-335-29-58 email: alexlaz58@rambler.ru lat: 59.93863 lon: 30.31413 facility: PiterKlinika LLC status: RECRUITING city: Saint Petersburg zip: 196158 country: Russian Federation name: Tatiana Pak, MD,PhD role: CONTACT phone: +7 (981) 851 8150 email: pte@list.ru lat: 59.93863 lon: 30.31413 facility: St. Petersburg State Budgetary Healthcare Institution "City Pediatric Polyclinic No. 35" status: RECRUITING city: Saint Petersburg zip: 196191 country: Russian Federation name: Tatiana I Antonova, MD, PhD role: CONTACT phone: +7-812-246-46-45 email: antian@bk.ru lat: 59.93863 lon: 30.31413 hasResults: False