NCT06379542

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

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 252 (estimated)
• Sponsor: Valenta Pharm JSC · Industry
• Sex: All
• Age: 6 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Respiratory Infection

Interventions

Type	Name	Description
DRUG	XC8	40 mg/day or 80 mg/day for 7-14 days
DRUG	Placebo	2 tablets/day for 7-14 days

Timeline

• Start date: 2023-12-04
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2024-04-23
• Last updated: 2024-04-23

Locations

6 sites across 1 country: Russia