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Multicenter Study to Evaluate Efficacy, Tolerability, Safety of Derinat

Primary Purpose

Respiratory Infections in Children

Status

Unknown status

Phase

Phase 3

Locations

Russian Federation

Study Type

Interventional

Intervention

Derinat

About this trial

This is an interventional treatment trial for Respiratory Infections in Children focused on measuring Derinat, Respiratory infection, Children

Eligibility Criteria

1 Day - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Signed informed consent
Male and female patients.
The age of the child at the time of first intranasal administration of drug for age group 1: 12 years to <18 years; for age group 2: from 6 years to <12 years; for age group 3: from 2 years to <6 years; for age group 4: 7 months to <2 years; for age group 5: from 0 months to 6 months.
Outpatient and inpatient patients hospitalized for epidemiological reasons, with a diagnosis of acute respiratory infection of the upper respiratory tract of mild to moderate severity. (ICD 10: J00 - J06 Acute respiratory infections of the upper respiratory tract).
The positive result of the enzyme immunoassay express test for pathogens of acute respiratory infection of the upper respiratory tract on screening.
At least one episode of body temperature up to 38C and above within 48 hours prior to screening.
Presence of at least one of the following mild to moderate symptoms at screening: headache, weakness/malaise, muscle pain/aching, feeling of heat/chills.
The duration of the disease is not more than 48 hours at the time of screening according to the patient/parents/adoptive parents.
Adequate contraceptive methods during the study for the patients with childbearing potential

Exclusion Criteria:

Positive express test (in urine) for pregnancy in patients with childbearing potential (menarche).
Individual intolerance or hypersensitivity to any of the components of the drug according to the medical history.
Taking any drugs with immunomodulatory effect less than 30 days before screening according to medical history.
The presence of complications of acute respiratory infection of the upper respiratory tract, signs of severe disease at the time of screening (fever more than 39ºC, febrile convulsions).
Acute infectious diseases: diphtheria, measles, infectious mononucleosis, herpes type 1 and 2, rubella, scarlet fever, acute BGSA-tonsillopharyngitis at the time of screening or 30 days before screening.
Chronic diseases of the respiratory system (Bronchial asthma, COPD).
HIV infection, chronic viral hepatitis B or C (according to history).
Impaired renal function with serum creatinine level more than 1.5 times higher than the upper limit of the normal range.
Severe liver failure or active liver disease (including viral hepatitis B or C) and increase of ALT and AST more than 5 times of upper limit of the normal range.
Participation in any clinical trials and / or taking an experimental drug within 30 days prior to the screening visit.
Other significant diseases and conditions of the patient, including mental and physical diseases

Sites / Locations

Irina Gerasimova

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Derinat

Placebo

Arm Description

nasal drops

Outcomes

Primary Outcome Measures

Superiority of Derinat

Assessment of frequency of resolution of symptoms of acute respiratory infection of the upper respiratory tract confirmed by the absence of symptoms (0 points on the scale of evaluation of symptoms of acute upper respiratory infection during at least 24 hours

Secondary Outcome Measures

Efficacy of Derinat

Assessment of frequency of resolution of symptoms of acute upper respiratory infection? time from start of investigational therapy to resolution of symptoms of acute upper respiratory infection and assessment of frequency of elimination of pathogens of acute respiratory infections of the upper respiratory tract from the mucous membrane of the nasopharynx and oropharynx to Day 8

Safety of Derinat

Assessment of incidence of complications in acute upper respiratory tract infection and the incidence of adverse events and serious adverse events of varying severity according to subjective complaints, laboratory tests, physical examination, assessment of vital signs and electrocardiography

Full Information

NCT ID

NCT04149431

First Posted

October 16, 2019

Last Updated

October 30, 2019

Sponsor

PharmPak, LLC

1. Study Identification

Unique Protocol Identification Number

NCT04149431

Brief Title

Multicenter Study to Evaluate Efficacy, Tolerability, Safety of Derinat

Official Title

Multicenter Double Blinded Placebo-controlled Randomized Study to Evaluate Clinical Efficacy, Tolerability, Safety of Medical Product Derinat®, Solution for External and Local Use 0.25% in Acute Infections of Respiratory System in Children

Study Type

Interventional

2. Study Status

Record Verification Date

October 2019

Overall Recruitment Status

Unknown status

Study Start Date

December 15, 2019 (Anticipated)

Primary Completion Date

May 31, 2022 (Anticipated)

Study Completion Date

May 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

PharmPak, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This multicenter prospective double blinded placebo-controlled randomized study is designed to to evaluate clinical efficacy, tolerability and safety of medical product Derinat®, solution for external and local use 0.25% in acute infections of respiratory system in children

Detailed Description

This is a multi-center, double-blind, randomized phase III-IV clinical trial in parallel groups to evaluate the efficacy and safety of Derinat versus Placebo in patients with acute upper respiratory tract infection. The study will include only patients with mild to moderate acute upper respiratory tract infection, without complications. According to the recommendations of the FDA (Guidance for Industry Influenza: Developing Drugs for Treatment and/or Prophylaxis) this category of patients is the best suited for placebo-controlled studies, because the expected serious risks without treatment are negligible. For studies evaluating the therapy of patients with mild to moderate acute respiratory upper respiratory tract infection without complications, a placebo-controlled trial design is preferred, as opposed to designs with no less efficacy (non-inferiority). This study provides for the inclusion of both outpatient patients and patients admitted to the hospital for epidemiological indications (i.e. patients with acute respiratory infection of the upper respiratory tract of mild and moderate severity without complications that pose an epidemic risk. Assessment of criteria of severity of acute respiratory infection of the upper respiratory tract will be carried out by Investigator based on standards of diagnosis and treatment of infectious diseases in children at the stages of medical care, depending on the forms of severity of the disease. The study is planned sequentially in 5 age groups. The study begins with the older age group and as the results on the safety of the drug are obtained, in the course of the study, it is possible to move to younger age groups

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Respiratory Infections in Children

Keywords

Derinat, Respiratory infection, Children

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Model Description

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

double blind randomized placebo controlled study

Allocation

Randomized

Enrollment

350 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Derinat

Arm Type

Active Comparator

Arm Description

nasal drops

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

nasal drops

Intervention Type

Drug

Intervention Name(s)

Derinat

Other Intervention Name(s)

desoxyribonucleate sodium

Intervention Description

desoxyribonucleate sodium

Primary Outcome Measure Information:

Title

Superiority of Derinat

Description

Time Frame

through study completion, an average of 30 days

Secondary Outcome Measure Information:

Title

Efficacy of Derinat

Description

Time Frame

through study completion, an average of 30 days

Title

Safety of Derinat

Description

Time Frame

through study completion, an average of 30 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Day

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Signed informed consent Male and female patients. The age of the child at the time of first intranasal administration of drug for age group 1: 12 years to <18 years; for age group 2: from 6 years to <12 years; for age group 3: from 2 years to <6 years; for age group 4: 7 months to <2 years; for age group 5: from 0 months to 6 months. Outpatient and inpatient patients hospitalized for epidemiological reasons, with a diagnosis of acute respiratory infection of the upper respiratory tract of mild to moderate severity. (ICD 10: J00 - J06 Acute respiratory infections of the upper respiratory tract). The positive result of the enzyme immunoassay express test for pathogens of acute respiratory infection of the upper respiratory tract on screening. At least one episode of body temperature up to 38C and above within 48 hours prior to screening. Presence of at least one of the following mild to moderate symptoms at screening: headache, weakness/malaise, muscle pain/aching, feeling of heat/chills. The duration of the disease is not more than 48 hours at the time of screening according to the patient/parents/adoptive parents. Adequate contraceptive methods during the study for the patients with childbearing potential Exclusion Criteria: Positive express test (in urine) for pregnancy in patients with childbearing potential (menarche). Individual intolerance or hypersensitivity to any of the components of the drug according to the medical history. Taking any drugs with immunomodulatory effect less than 30 days before screening according to medical history. The presence of complications of acute respiratory infection of the upper respiratory tract, signs of severe disease at the time of screening (fever more than 39ºC, febrile convulsions). Acute infectious diseases: diphtheria, measles, infectious mononucleosis, herpes type 1 and 2, rubella, scarlet fever, acute BGSA-tonsillopharyngitis at the time of screening or 30 days before screening. Chronic diseases of the respiratory system (Bronchial asthma, COPD). HIV infection, chronic viral hepatitis B or C (according to history). Impaired renal function with serum creatinine level more than 1.5 times higher than the upper limit of the normal range. Severe liver failure or active liver disease (including viral hepatitis B or C) and increase of ALT and AST more than 5 times of upper limit of the normal range. Participation in any clinical trials and / or taking an experimental drug within 30 days prior to the screening visit. Other significant diseases and conditions of the patient, including mental and physical diseases

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Irina Gerasimova, Dr.

Phone

+79168008485

gerasimova@derinat.ru

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Irina Gerasimova, Dr.

Organizational Affiliation

PharmPak, LLC

Official's Role

Study Director

Facility Information:

Facility Name

Irina Gerasimova

City

Moscow

Country

Russian Federation

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Irina Gerasimova

gerasimova@derinat.ru

12. IPD Sharing Statement

Learn more about this trial

Multicenter Study to Evaluate Efficacy, Tolerability, Safety of Derinat

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