Clinical Trial of Safety and Clinical Efficiency of Ergoferon in Liquid Dosage Form in Treatment of Acute Upper Respiratory Tract Infections in Adult Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Materia Medica Holding
ClinicalTrials.gov Identifier:
NCT01765920
First received: January 9, 2013
Last updated: April 7, 2015
Last verified: January 2013
  Purpose

The purpose of this study is:

  • to assess safety of the liquid dosage form of Ergoferon for treatment of acute upper respiratory tract infections in adult patients.
  • to assess clinical efficiency of the liquid dosage form of Ergoferon for treatment of acute upper respiratory tract infections in adult patients.

Condition Intervention Phase
Acute Upper Respiratory Tract Infections
Drug: Ergoferon
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multicentre Double-blind Placebo-controlled Parallel-group Randomized Clinical Trial of Safety and Clinical Efficiency of Ergoferon in Liquid Dosage Form in Treatment of Acute Upper Respiratory Tract Infections in Adult Patients

Further study details as provided by Materia Medica Holding:

Primary Outcome Measures:
  • Average duration of fever (body temperature over 37.0 С) (according to the patient's diary). [ Time Frame: 7(± 1) days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Dynamics of the clinical manifestations of ARI according to the objective medical examination (summary score of the CCQ scale at first, third and seventh days of treatment) [ Time Frame: 7(± 1) days ] [ Designated as safety issue: No ]

Estimated Enrollment: 282
Study Start Date: December 2012
Study Completion Date: April 2015
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ergoferon (5 ml 3 times a day) Drug: Ergoferon
Safety and Efficiency of liquid dosage form
Placebo Comparator: Placebo (5 ml 3 times a day) Drug: Placebo
Safety and Efficiency of liquid dosage form

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients of both sexes aged from 18 to 60 inclusively.
  2. Patients who consulted a doctor during the increase of seasonal incidence within 24 hours after the onset of acute upper respiratory tract infection.
  3. Body temperature at least 37.8 °С at the moment of examination by the doctor.
  4. Presence of two or more moderate level symptoms or three or more mild level symptoms according to the CCQ scale.
  5. The possibility to start therapy within 24 hours after the onset of the first symptoms of acute upper respiratory tract infection.
  6. Usage of contraceptive methods by the patients of both the sexes during the trial and within 30 days after ending of the participation in the trial.
  7. Availability of information sheet (informed consent form for taking part in the clinical trial) signed by the patient.

Exclusion Criteria:

  1. Suspected invasive bacterial infection or presence of severe disease requiring use of antibacterial drugs (including sulfanilamides).
  2. Suspected initial manifestations of diseases that have symptoms similar to ARI (other infectious diseases, flu-like symptoms at the onset of systemic connective tissue disorders, oncohematological and other pathologies).
  3. Exacerbation or decompensation of chronic diseases affecting the patient's ability to participate in a clinical trial.
  4. Oncological diseases.
  5. Medical history of polyvalent allergy.
  6. Allergy / intolerance to any of the components of medications used in the treatment.
  7. Impaired glucose tolerance, diabetes mellitus type 1 and 2.
  8. Hereditary fructose intolerance (due to the presence of maltitol in the examined medicine).
  9. Intake of medicines listed in the section "Prohibited concomitant treatment" for 1 month prior to participation in the trial.
  10. Pregnancy, breast feeding.
  11. Drugs usage, alcohol usage in the amount over 2 units of alcohol per day.
  12. Patients with mental disorders.
  13. Patients, who from investigator's point of view will fail to comply with the observation requirements of the trial or with the intake regimen of the investigated medicines.
  14. Participation in other clinical trials in the course of 3 months prior to inclusion into the present trial.
  15. Other factors, which hinder the patient's participation in the trial (for example, planned trips or business trips).
  16. The patient is related to the research personnel of the centre who are directly involved in the trial or are the immediate family of the researcher. The immediate family includes husband / wife, parents, children or brothers / sisters, regardless of whether they are natural or adopted.
  17. The patient works for OOO "NPF "Materia Medica Holding", i.e. s/he is the company's employee, temporary contract worker, and designated official responsible for carrying out the research or their immediate family.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01765920

Locations
Russian Federation
Non-governmental Health Care Institution "Road Clinical Hospital at the train station Chelyabinsk of OJSC "Russian Railways"
Chelyabinsk, Russian Federation, 454091
State Budgetary Educational Institution of Higher Professional Education "Kazan State Medical University"
Kazan, Russian Federation, 420012
Federal State Budgetary Institution "Polyclinic № 3" of Affairs Management Department of the President of Russian Federation
Moscow, Russian Federation, 129090
Federal State Budgetary Institution "Scientific Research Institute for Vaccines and Serum named after I.I.Mechnikov" of Russian Academy of Medical Science
Moscow, Russian Federation, 105064
State Budgetary Educational Institution of Higher Professional Education "The Russian National Research Medical University named after N.I. Pirogov"
Moscow, Russian Federation, 117997
Municipal Health Care Institution "Podolsk city clinical hospital №3"
Podolsk, Russian Federation, 142105
Regional State Budgetary Health Care Institution "Policlinic № 6"
Smolensk, Russian Federation, 214000
The Non-governmental Health Care Institution "Road Hospital of the Open Joint Stock Company" Russian Railways"
St. Petersburg, Russian Federation, 19527
St. Petersburg State Budgetary Health Care Institution " Nevsky Region Сity Polyclinic №25"
St. Petersburg, Russian Federation, 193312
St. Petersburg State Budgetary Health Care Institution "Medical Exercises Dispensary" of Krasnogvardeysky District
St. Petersburg, Russian Federation, 195112
St. Petersburg State Budgetary Health Care Institution "Сity Polyclinic № 117"
St. Petersburg, Russian Federation, 194358
St. Petersburg State Budgetary Health Care Institution "Сity Polyclinic № 4"
St. Petersburg, Russian Federation, 199178
Federal State Budgetary Health Care Institution Policlinic № 1 of the Russian Academy of Sciences
St. Petersburg, Russian Federation, 199034
State Budgetary Educational Institution of Higher Professional Education "St. Petersburg State Medical University named after I.P. Pavlov"
St. Petersburg, Russian Federation, 197022
State Educational Institution of Higher Professional Education "Voronezh State Medical Academy of N. N. Burdenko" Ministry of Health of the Russian Federation
Voronezh, Russian Federation, 394036
State Budgetary Educational Institution of Higher Professional Education "Yaroslavl State Medical Academy"
Yaroslavl, Russian Federation, 150000
State Budgetary Health Care Institution of the Yaroslavl region "Regional Clinical Hospital"
Yaroslavl, Russian Federation, 150062
Sponsors and Collaborators
Materia Medica Holding
  More Information

No publications provided

Responsible Party: Materia Medica Holding
ClinicalTrials.gov Identifier: NCT01765920     History of Changes
Other Study ID Numbers: MMH-ER-006
Study First Received: January 9, 2013
Last Updated: April 7, 2015
Health Authority: Russia: Ministry of Health of the Russian Federation

Additional relevant MeSH terms:
Infection
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 29, 2015