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XC8 in the Treatment of Patients With Acute Respiratory Viral Infection

NCT03441373 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 320

Last updated 2018-02-23

No results posted yet for this study

Summary

A multicenter double-blind, randomized, placebo-controlled, parallel-group comparative Phase II / III clinical study to assess safety, tolerability, efficacy and optimal dose ranging of XC8 vs. placebo in patients with uncomplicated influenza or other ARVI during a 5-day treatment.

The primary objective of the study was to demonstrate the difference in time before the onset of a sustained improvement in clinical symptoms according to the Severity Rating Scale for ARVI, and to determine the optimal dose of XC8 in the treatment of influenza and other ARVI.

Conditions

Interventions

DRUG

XC8 20 mg

once daily during 5 days.

DRUG

XC8 100 mg

once daily during 5 days.

DRUG

XC8 200 mg

once daily during 5 days.

DRUG

Placebo

once daily during 5 days.

Sponsors & Collaborators

  • PHARMENTERPRISES LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-03
Primary Completion
2017-02-09
Completion
2017-02-09

Countries

  • Russia

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03441373 on ClinicalTrials.gov