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RECRUITING
NCT06379542
PHASE3

Efficacy and Safety of XC8, Film-coated Tablets, in Children With Acute Respiratory Viral Infections

Sponsor: Valenta Pharm JSC

View on ClinicalTrials.gov

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.

Official title: Double-blind Placebo-controlled Multicenter Randomized Clinical Trial to Evaluate the Efficacy and Safety of XC8, Film-coated Tablets (Valenta Pharm JSC, Russia), in Children Aged 6-17 Years With Dry Non-productive Cough Against the Background of Acute Respiratory Viral Infection

Key Details

Gender

All

Age Range

6 Years - 17 Years

Study Type

INTERVENTIONAL

Enrollment

252

Start Date

2023-12-04

Completion Date

2025-12-31

Last Updated

2024-04-23

Healthy Volunteers

No

Interventions

DRUG

XC8

40 mg/day or 80 mg/day for 7-14 days

DRUG

Placebo

2 tablets/day for 7-14 days

Locations (6)

City Pediatric Outpatient Clinic number 5

Perm, Russia

Professors' Clinic LLC.

Perm, Russia

St. Petersburg State Budgetary Healthcare Institution "City Polyclinic No. 44"

Saint Petersburg, Russia

ArsVite North-West, LLC

Saint Petersburg, Russia

PiterKlinika LLC

Saint Petersburg, Russia

St. Petersburg State Budgetary Healthcare Institution "City Pediatric Polyclinic No. 35"

Saint Petersburg, Russia