Clinical Trial of Safety and Efficacy of Ergoferon in Liquid Dosage Form in Treatment of Acute Upper Respiratory Tract Infections in Adults

NCT01765920 | Completed Phase 3 Results

• 1 other identifier: MMH-ER-006
• Study Type: interventional
• Target: 342
• Locations: 1 country
• Sites: 18

Brief Summary

The purpose of this study is:

• to evaluate safety of the liquid dosage form of Ergoferon in the treatment of acute upper respiratory tract infections in adults;
• to evaluate clinical efficacy of the liquid dosage form of Ergoferon in the treatment of acute upper respiratory tract infections in adults.

Conditions

Acute Upper Respiratory Tract Infections

Outcome Measures

Primary Outcomes (1)

• Average Duration of Fever.

  Primary outcome measure is based on the indicators of tympanic thermometry recorded by the patient in the diary during the period of treatment and observation. Thermometry is performed twice a day (morning and evening). The criterion of Duration of Fever is the time from enrollment to the first return to the afebrile state or the normalization of tympanic temperature (tympanic temperature ≤37.0 degree Celsius \[°C\]).

  1-7 days

Secondary Outcomes (4)

• Dynamics of Acute Upper Respiratory Tract Infections (URTI) Symptoms Severity According to the Physical Examination by the Doctor.

  Day 1, 3, and 7.

• Dynamics of Acute URTI Symptoms Severity According to the Daily Wisconsin Upper Respiratory Symptom Survey - 21 (WURSS-21) Assessment of the Patient (Including the Total WURSS-21 Score, "Symptoms" Domain Score, and "Ability" Domain Score).

  Days 1 to 8.

• Percentage of Patients Who Used Antipyretics.

  Days 1, 2, 3, 4, and 5.

• Percentage of Patients Who Have a Worsening of Disease.

  Days 1, 2, 3, 4.,5, 6, and 7.

Study Arms (2)

Ergoferon (5 ml 3 times a day)

EXPERIMENTAL

Oral use. Dose per administration: 1 dosing spoon (5ml) without food. For best effect, the solution should be held in the mouth before swallowing. Dosing scheme. One dose every 30 minutes for the first 2 hours, followed by three more doses spaced regularly during the rest of the day. From day 2 to 5: 1 spoon taken 3 times daily.

Drug: Ergoferon

Placebo (5 ml 3 times a day)

PLACEBO COMPARATOR

Oral use. Placebo using Ergoferon scheme.

Drug: Placebo

Interventions

Ergoferon DRUG

5 ml 3 times a day

Ergoferon (5 ml 3 times a day)

Placebo DRUG

5 ml 3 times a day

Placebo (5 ml 3 times a day)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients of both genders aged from 18 to 60 years inclusively.
• Patients who visited a doctor during the increase of seasonal incidence within 24 hours after the onset of acute respiratory infection of the upper respiratory tract.
• Body temperature ≥37,8°C at the moment of examination by the doctor.
• Presence of two or more moderate severity symptoms or three or more mild severity symptoms according to the Common Cold Questionnaire (CCQ).
• The possibility to start therapy within 24 hours from the onset of the first symptoms of acute respiratory infection of the upper respiratory tract.
• The use of contraceptive methods by the patients of both the sexes during the study and within 30 days after completion of participation in the study.
• Availability of signed patient information sheet (Informed Consent form) for participation in the clinical trial.

You may not qualify if:

• Suspected invasive bacterial infection or the presence of a severe disease requiring use of antibacterial drugs (including sulfanilamides).
• Suspected initial manifestations of diseases that have symptoms similar to acute URTI (other infectious diseases, flu-like symptoms at the onset of systemic connective tissue disorders, hematologic neoplasms and other pathologies).
• Exacerbated or decompensated chronic diseases affecting a patient's ability to participate in the clinical trial.
• Oncological diseases.
• Medical history of polyvalent allergy.
• Allergy/intolerance to any of the components of medications used in the treatment.
• Impaired glucose tolerance, diabetes mellitus type 1 and 2.
• Hereditary fructose intolerance (due to the presence of maltitol in the study drug).
• Pregnancy, breastfeeding.
• Consumption of narcotics, alcohol \> 2 alcohol units per day.
• Patients with mental disorders.
• Patients who, from the investigator's point of view, will fail to comply with the observation requirements of the trial or with the regimen of the study drugs.
• Participation in other clinical studies within 3 months prior to enrollment in the current trial.
• Other factors, which hinder the patient's participation in the trial (for example, planned trips or business trips).
• Patients are related to the research staff of the clinical trial site who are directly involved in the trial or are the immediate family member of the researcher. The immediate family members include husband/wife, parents, children or brothers (or sisters), regardless of whether they are natural or adopted.

Sponsors & Collaborators

• Materia Medica Holding: lead

Study Sites (18)

Non-governmental Health Care Institution "Road Clinical Hospital at the train station Chelyabinsk of OJSC "Russian Railways"

Chelyabinsk, 454091, Russia

Location

State Budgetary Educational Institution of Higher Professional Education "Kazan State Medical University"

Kazan', 420012, Russia

Location

Federal State Budgetary Institution "Scientific Research Institute for Vaccines and Serum named after I.I.Mechnikov" of Russian Academy of Medical Science

Moscow, 105064, Russia

Location

State Budgetary Educational Institution of Higher Professional Education "The Russian National Research Medical University named after N.I. Pirogov"/Outpatient Therapy Department of Medicine Faculty

Moscow, 117997, Russia

Location

State Budgetary Educational Institution of Higher Professional Education "The Russian National Research Medical University named after N.I. Pirogov"

Moscow, 117997, Russia

Location

Federal State Budgetary Institution "Polyclinic № 3" of Affairs Management Department of the President of Russian Federation

Moscow, 129090, Russia

Location

Municipal Health Care Institution "Podolsk city clinical hospital №3"

Podolsk, 142105, Russia

Location

St. Petersburg State Budgetary Health Care Institution " Nevsky Region Сity Polyclinic №25"

Saint Petersburg, 193312, Russia

Location

St. Petersburg State Budgetary Health Care Institution "Сity Polyclinic № 117"

Saint Petersburg, 194358, Russia

Location

St. Petersburg State Budgetary Health Care Institution "Medical Exercises Dispensary" of Krasnogvardeysky District

Saint Petersburg, 195112, Russia

Location

The Non-governmental Health Care Institution "Road Hospital of the Open Joint Stock Company" Russian Railways"

Saint Petersburg, 19527, Russia

Location

State Budgetary Educational Institution of Higher Professional Education "St. Petersburg State Medical University named after I.P. Pavlov"

Saint Petersburg, 197022, Russia

Location

Federal State Budgetary Health Care Institution Policlinic № 1 of the Russian Academy of Sciences

Saint Petersburg, 199034, Russia

Location

St. Petersburg State Budgetary Health Care Institution "Сity Polyclinic № 4"

Saint Petersburg, 199178, Russia

Location

Regional State Budgetary Health Care Institution "Policlinic № 6"

Smolensk, 214000, Russia

Location

State Educational Institution of Higher Professional Education "Voronezh State Medical Academy of N. N. Burdenko" Ministry of Health of the Russian Federation

Voronezh, 394036, Russia

Location

State Budgetary Educational Institution of Higher Professional Education "Yaroslavl State Medical Academy"

Yaroslavl, 150000, Russia

Location

State Budgetary Health Care Institution of the Yaroslavl region "Regional Clinical Hospital"

Yaroslavl, 150062, Russia

Location

MeSH Terms

Interventions

ergoferon

Results Point of Contact

• Title: Mikhail Putilovskiy, MD, PhD, Clinical and Medical Department Director
• Organization: Materia Medica Holding

PutilovskiyMA@materiamedica.ru

+74952761571

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2013
• First Posted: January 10, 2013
• Study Start: December 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: April 1, 2015
• Last Updated: January 5, 2021
• Results First Posted: December 11, 2020

Record last verified: 2019-01

Locations

RU (18)