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 is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Materia Medica Holding
Sponsor:
Information provided by (Responsible Party):
Materia Medica Holding
ClinicalTrials.gov Identifier:
NCT01765920
First received: January 9, 2013
Last updated: February 26, 2014
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
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: February 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

Contacts
Contact: Mikhail Putilovskiy, MD +74957836804 ext 302 PutilovskiyMA@materiamedica.ru

Locations
Russian Federation
Non-governmental Health Care Institution "Road Clinical Hospital at the train station Chelyabinsk of OJSC "Russian Railways" Terminated
Chelyabinsk, Russian Federation, 454091
State Budgetary Educational Institution of Higher Professional Education "Kazan State Medical University" Recruiting
Kazan, Russian Federation, 420012
Contact: Rustem Khamitov, Prof         
Principal Investigator: Rustem Khamitov, Prof         
State Budgetary Educational Institution of Higher Professional Education "The Russian National Research Medical University named after N.I. Pirogov" Recruiting
Moscow, Russian Federation, 117997
Contact: Boris Bart, Prof         
Principal Investigator: Boris Bart, Prof         
Federal State Budgetary Institution "Scientific Research Institute for Vaccines and Serum named after I.I.Mechnikov" of Russian Academy of Medical Science Completed
Moscow, Russian Federation, 105064
LLC "Panacea Clinic" Withdrawn
Moscow, Russian Federation, 117630
Federal State Budgetary Institution "Polyclinic № 3" of Affairs Management Department of the President of Russian Federation Recruiting
Moscow, Russian Federation, 129090
Contact: Elena Minina, MD         
Principal Investigator: Elena Minina, MD         
State Budgetary Educational Institution of Higher Professional Education "The Russian National Research Medical University named after N.I. Pirogov" Recruiting
Moscow, Russian Federation, 117997
Contact: Marina Mikhailusova, MD         
Principal Investigator: Marina Mikhailusova, MD         
Municipal Health Care Institution "Podolsk city clinical hospital №3" Enrolling by invitation
Podolsk, Russian Federation, 142105
Regional State Budgetary Health Care Institution "Policlinic № 6" Enrolling by invitation
Smolensk, Russian Federation, 214000
St. Petersburg State Budgetary Health Care Institution "Medical Exercises Dispensary" of Krasnogvardeysky District Terminated
St. Petersburg, Russian Federation, 195112
St. Petersburg State Budgetary Health Care Institution "Сity Polyclinic № 4" Terminated
St. Petersburg, Russian Federation, 199178
St. Petersburg State Budgetary Health Care Institution " Nevsky Region Сity Polyclinic №25" Enrolling by invitation
St. Petersburg, Russian Federation, 193312
State Budgetary Educational Institution of Higher Professional Education "St. Petersburg State Medical University named after I.P. Pavlov" Recruiting
St. Petersburg, Russian Federation, 197022
Contact: Mikhail Ilkovich, Prof         
Principal Investigator: Mikhail Ilkovich, Prof         
State Budgetary Educational Institution of Higher Professional Education "St. Petersburg State Medical University named after I.P. Pavlov" Terminated
St. Petersburg, Russian Federation, 197002
Federal State Budgetary Health Care Institution Policlinic № 1 of the Russian Academy of Sciences Enrolling by invitation
St. Petersburg, Russian Federation, 199034
St. Petersburg State Budgetary Health Care Institution "Сity Polyclinic № 117" Terminated
St. Petersburg, Russian Federation, 194358
State Educational Institution of Higher Professional Education "Voronezh State Medical Academy of N. N. Burdenko" Ministry of Health of the Russian Federation Recruiting
Voronezh, Russian Federation, 394036
Contact: Andrey Babkin, MD,PhD, ScD, professor         
Principal Investigator: Andrey Babkin, MD, PhD, ScD, professor         
State Budgetary Health Care Institution of the Yaroslavl region "Regional Clinical Hospital" Recruiting
Yaroslavl, Russian Federation, 150062
Contact: Maria Yanovskaya, MD         
Principal Investigator: Maria Yanovskaya, MD         
State Budgetary Educational Institution of Higher Professional Education "Yaroslavl State Medical Academy" Recruiting
Yaroslavl, Russian Federation, 150000
Contact: Dmitriy Petrov, MD         
Principal Investigator: Dmitriy Petrov, MD         
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: February 26, 2014
Health Authority: Russia: Ministry of Health of the Russian Federation

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

ClinicalTrials.gov processed this record on October 22, 2014