Efficacy and Safety Study of Ingavirin® to Treat Influenza and Acute Respiratory Viral Infections in Patients 13-17 y.o.
NCT03206346 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 161
Last updated 2017-07-02
Summary
The purpose of this study is to determine whether Ingavirin ® dosed 60 mg daily is effective and safe in the treatment of influenza and other acute respiratory viral infections in 13-17 years old patients.
Conditions
- Influenza, Human
- Acute Respiratory Infection
- Viral Infection
- Common Cold
Interventions
- DRUG
-
Ingavirin
Ingavirin ( Imidazolyl ethanamide pentandioic acid) capsules, 60 mg once daily, regardless of meal, for 5 days.
- DRUG
-
Placebo oral capsule
Placebo, capsules daily for 5 days.
Sponsors & Collaborators
-
Valenta Pharm JSC
lead INDUSTRY
Principal Investigators
-
Ekaterina Zakharova, MD, PhD · Valenta Pharm JSC
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 13 Years
- Max Age
- 17 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-01-31
- Primary Completion
- 2012-11-30
- Completion
- 2013-08-31
Countries
- Russia
Study Locations
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