NCT05269329

Efficacy and Safety of XC8, Film-coated Tablets, 10 mg in Patients With Dry Non-productive Cough Against Acute Respiratory Viral Infection

Double-blind Placebo-controlled Multicenter Randomized Clinical Trial to Assess Efficacy and Safety of HC8, Film-coated Tablets, 10 mg (Valenta Pharm, Russia) in Patients With Dry Non-productive Cough Against Acute Respiratory Viral Infection

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: Valenta Pharm JSC · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Study to assess the efficacy and safety of XC8, film-coated tablets, 10 mg in comparison with placebo in patients with dry non-productive cough against acute respiratory infections, and to determine the dosing regimen of XC8, film-coated tablets, 10 mg for treatment of dry non-productive cough against acute respiratory infections.

Conditions

• Common Cold
• Acute Respiratory Infection
• Influenza, Human

Interventions

Type	Name	Description
DRUG	XC8, film-coated tablets, 20 mg/day	20 mg/day (1 tablet twice a day)
DRUG	XC8, film-coated tablets, 40 mg/day	40 mg/day (2 tablets twice a day)
DRUG	XC8, film-coated tablets, 80 mg/day	80 mg/day (4 tablets twice a day)
DRUG	Placebo	1, 2, or 4 tablets twice a day

Timeline

• Start date: 2021-04-26
• Primary completion: 2021-10-26
• Completion: 2021-10-26
• First posted: 2022-03-08
• Last updated: 2022-03-08

Locations

9 sites across 1 country: Russia