Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| XC8, film-coated tablets, 20 mg, 40 mg | Experimental | 6-12 years old: 20 mg tablet, 2 per day for 7-14 days on top of standard therapy. 13-17 years old: 40 mg tablet, 2 per day for 7-14 days on top of standard therapy. |
|
| Placebo | Placebo Comparator | 2 tablets per day for 7-14 days on top of standard therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XC8 | Drug | 40 mg/day or 80 mg/day for 7-14 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Decrease in percentage of patients with ≥50% reduction in number of cough attacs by day 5 relative to day 1 | Difference between the percentage of patients with ≥50% reduction in number of cough attacs by day 5 and by day 1 | Assessment will include data collected within 24 hours before day 1 and day 5 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of cough attacks by day 5, day 8, day 11 and day 15 | Number of cough attacks registered by days 5, 8, 11, and 15 | The estimate will include data collected within 24 hours before day 5, day 8, day 11 and day 15, respectively |
| Time (days) from visit 1 until clinical cough cure is achieved |
Not provided
Inclusion Criteria:
Reliable contraceptive methods are: sexual rest, condom use in combination with spermicide.
Non-inclusion Criteria:
Exclusion criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City Pediatric Outpatient Clinic number 5 | Recruiting | Perm | 614066 | Russia |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo |
| Drug |
2 tablets/day for 7-14 days |
|
Clinical cure of cough is defined as having ≤ 1 score on the "daytime cough" and "nighttime cough" sections of the Daytime and Nighttime Cough Scale (a scale with scores from 0 to 5, where 0 is the absence of cough, and 5 is a severe cough that makes daytime activity impossible or a cough that makes it impossible to sleep) for at least 3 consecutive days. |
| The assessment will include the time from visit 1 to the first day of consecutive days on which ≤ 1 score on the "daytime cough" and "nighttime cough" sections of the scales is recorded through the end of treatment (within timeframe from 7 to 14 days) |
| 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 | Score on the "daytime cough" and "nighttime cough" sections of the Daytime and Nighttime Cough Scale (a scale with scores from 0 to 5, where 0 is the absence of cough, and 5 is a severe cough that makes daytime activity impossible or a cough that makes it impossible to sleep) | The score for the "daytime cough" section will include data for days 4, 7, 10, and 14, respectively. The score for the "night cough" section will include data from the night prior to days 5, 8, 11, and 15, respectively. |
| Change (score) in cough severity by digital rating scale by days 5, 8, 11 and 15 compared to visit 1 | Score assessed with digital rating scale (a scale from 0 to 10, where 0 is the absence of cough, and 10 is the most excruciating cough imaginable) | The score will include data 24 h before days 5, 8, 11 and 15, respectively |
| Percentage of patients needed acetylcysteine | Percentage of patients who were prescribed a preparation with acetylcysteine for transition of dry cough to wet cough | Day 1 - Day 21±2 |
| Proportion of patients with complete resolution of all symptoms of acute respiratory infection by days 4, 7, 10 and 14 | Complete resolution of all symptoms is defined as achieving a score of 0 for each symptom on the Basic Symptom Rating Scale for acute respiratory infections (a 6-item inventory including Fatigue, Sore throat, Nasal congestion, Rhinorrhea, Myalgia, and Headache, assessed using a score from 0 to 3, where 0 is the absence of the symptom, and 3 is the most severe symptom severity) | Days 4, 7, 10, 14 |
| Percentage of patients with each category of Global Physician-Researcher Assessment of Therapy Effectiveness at visits 2, 3, 4, and 5 | Assessment of clinical effectiveness using Global Physician-Researcher Assessment of Therapy Effectiveness (a 5-point scale, where 1 is the absence of efficacy, and 5 is very high efficiency, meaning a complete cure of coughs) | Day 3-16 |
| Number of adverse events (AEs) | Total number of AEs stratified by severity and frequency | Day 0 - Day 21±2 |
| Adverse reactions | Frequency of adverse reactions | Day 0 - Day 21±2 |
| Serious adverse events (SAEs) | Frequency of serious adverse events (SAEs) associated with study drug/placebo use | Day 0 - Day 21±2 |
| Percentage of patients with AEs | Percentage of patients with at least one AE | Day 0 - Day 21±2 |
| Percentage of patients who interrupted treatment | Percentage of patients who interrupted treatment due to AE | Day 0 - Day 21±2 |
| Professors' Clinic LLC. | Recruiting | Perm | 614070 | Russia |
|
| St. Petersburg State Budgetary Healthcare Institution "City Polyclinic No. 44" | Recruiting | Saint Petersburg | 192071 | Russia |
|
| ArsVite North-West, LLC | Recruiting | Saint Petersburg | 194223 | Russia |
|
| PiterKlinika LLC | Recruiting | Saint Petersburg | 196158 | Russia |
|
| St. Petersburg State Budgetary Healthcare Institution "City Pediatric Polyclinic No. 35" | Recruiting | Saint Petersburg | 196191 | Russia |
|