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Clinical Trial of Clinical Efficiency and Safety of Ergoferon in Treatment of Influenza

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ClinicalTrials.gov Identifier: NCT01804946
Recruitment Status : Completed
First Posted : March 5, 2013
Results First Posted : June 23, 2015
Last Update Posted : June 23, 2015
Sponsor:
Information provided by (Responsible Party):
Materia Medica Holding

Tracking Information
First Submitted Date  ICMJE March 4, 2013
First Posted Date  ICMJE March 5, 2013
Results First Submitted Date  ICMJE April 13, 2015
Results First Posted Date  ICMJE June 23, 2015
Last Update Posted Date June 23, 2015
Study Start Date  ICMJE February 2011
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 1, 2015)
Percentage of Patients With Normal Body Temperature [ Time Frame: Day 1 to Day 5 ]
Axillary temperature (morning and evening) decline to or below 37.0 ºС (without subsequent increase during ≥24 h)
Original Primary Outcome Measures  ICMJE
 (submitted: March 4, 2013)
Proportion of patients whose body temperature normalized (no more than 37.0ºС) [ Time Frame: up to 5 days of the treatment ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 1, 2015)
  • Percentage of Patients With Resolution of Influenza Symptoms [ Time Frame: on the day 7 of the observation ]
    Assessment of the proportion of subjects with no clinical symptoms of the disease (fever, common and respiratory symptoms) at Study Day 7 (Visit 3). The severity of influenza symptoms was assessed by a physician with 0 to 3 point scale, where 0 means no symptom, 1=mild symptom, 2=moderate symptom, and 3=severe symptom
  • Time to Resolution of the Influenza [ Time Frame: Day 1 to Day 7 ]
    Time to resolution was considered as time to the absence of any flu symptom. Absence of symptoms was considered as axillary temperature decline to or below 37.0 ºС without subsequent rise, resolution of the common and respiratory symptoms. The duration of a symptom was defined by physician recorded presence/absence of the symptoms during a physical examination at Day 1 to Day 7.
  • Mean Body Temperature [ Time Frame: on days 1, 3 and 7 of the observation ]
    The axillary temperature was assessed during a physical examination at Day 1, 3 and 7; axillary temperature was assessed in degrees (Celsius, °С)
  • Severity of Influenza Symptoms (Total Score of the Common Symptoms and Respiratory Symptoms) [ Time Frame: on days 1, 3 and 7 of the observation ]
    The severity of influenza symptoms was assessed during a physical examination at Day 1, 3 and 7; common (10 symptoms) and respiratory (5 symptoms) symptom's total score was assessed with using the point scale: 0=No symptom; 1=Mild symptom; 2=Moderate symptom ; 3=Severe symptom. The Common Symptoms total score ranged from 0 (no symptoms) to 30 (severe symptoms). The Respiration Symptoms total score ranged from 0 (no symptoms) to 15 (severe symptoms)
  • The Number of the Antipyretic Intake [ Time Frame: Day 1 to Day 5 ]
    A subject recorded the number of antipyretic intake in patient diary.
  • Change in the Patient's Quality of Life. [ Time Frame: Day 7 vs. Day 1 ]
    The quality of life was assessed in influenza patients at baseline and at the end of the treatment period using the European Quality of Life Questionnaire (EQ5D) measuring the health status by five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression (each dimension is assessed by 1 to 3 point scale; the minimum score 5 points refers to the best status, 15 points refers to the worst status).
  • Change in the Subjective Health Status [ Time Frame: Day 7 vs. Day 1 ]
    The patient subjective health status assessment was based on Visual Analogue Scale - VAS). VAS includes a rating of current health status from 0 (worst) to 100 (best).
  • Percentage of Patients With Complications of the Influenza [ Time Frame: Day 1 to Day 7 ]
    Pneumonia, sinusitis, otitis media are examples of the influenza complications
Original Secondary Outcome Measures  ICMJE
 (submitted: March 4, 2013)
Proportion of patients whose influenza clinical manifestations were arrested [ Time Frame: on the day 7 of the observation ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures
 (submitted: March 4, 2013)
Intensity of influenza clinical manifestations (body temperature, intoxication signs, catarrh symptoms in scores) [ Time Frame: on days 1, 3 and 7 of the observation ]
 
Descriptive Information
Brief Title  ICMJE Clinical Trial of Clinical Efficiency and Safety of Ergoferon in Treatment of Influenza
Official Title  ICMJE Multicentre Open Label Comparative Parallel-group Randomized Clinical Trial of Clinical Efficiency and Safety of Ergoferon in Treatment of Influenza
Brief Summary

The purpose of this study is:

  • to assess clinical efficiency of Ergoferon for treatment of influenza
  • to assess safety of Ergoferon for treatment of influenza
  • to compare efficiency of Ergoferon and Tamiflu for treatment of influenza
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Influenza
Intervention  ICMJE
  • Drug: Ergoferon
    Safety and Efficiency of Ergoferon in treatment of Influenza
  • Drug: Oseltamivir
    Safety and Efficiency in treatment of Influenza
    Other Name: Tamiflu
Study Arms  ICMJE
  • Experimental: Ergoferon (1 tablet 3 times a day)
    1 tablet per 1 intake: on day 1 of the treatment 8 tablets (1 tablet every 30 minutes for the first 2 hours, then 1 tablet 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 tablet TID.
    Intervention: Drug: Ergoferon
  • Active Comparator: Oseltamivir(Tamiflu): 75 mg two times a day.
    Oseltamivir for 5 days (75 mg b.i.d.).
    Intervention: Drug: Oseltamivir
Publications * Rafalsky V, Averyanov A, Bart B, Minina E, Putilovskiy M, Andrianova E, Epstein O. Efficacy and safety of Ergoferon versus oseltamivir in adult outpatients with seasonal influenza virus infection: a multicenter, open-label, randomized trial. Int J Infect Dis. 2016 Oct;51:47-55. doi: 10.1016/j.ijid.2016.09.002. Epub 2016 Sep 8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 31, 2014)
161
Original Estimated Enrollment  ICMJE
 (submitted: March 4, 2013)
370
Actual Study Completion Date  ICMJE October 2014
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Patients of both sexes aged from 18 to 60 inclusively.
  2. Patients with body temperature >37,8°C at the moment of examination by the doctor; with at least one catarrh symptom (cough, rhinitis, sore throat) and one intoxication symptom (myalgia, fever/hyperhidrosis, malaise, weakness, headache) during seasonal influenza morbidity.
  3. Diagnosed influenza confirmed by express diagnostics (presence of antigens of influenza virus in nasal passages epithelium and proved by QuickVue immunological test).
  4. The possibility to start therapy within 24 hours after the onset of the first influenza symptoms.
  5. Signed Informed Consent form for participation in the study.

Exclusion Criteria:

  1. Patients aged below 18 years and above 60 years.
  2. Suspected invasive bacterial infection or presence of severe disease requiring use of antibacterial drugs (including sulfanilamides).
  3. Vaccination against influenza prior to epidemic season onset.
  4. Medical history of polyvalent allergy.
  5. Allergy/ intolerance to any of the components of medications used in the treatment.
  6. Exacerbation or decompensation of chronic diseases affecting the patient's ability to participate in the clinical trial.
  7. Chronic renal insufficiency.
  8. Intake of medicines listed in the section "Prohibited concomitant treatment" for 15 days prior to the inclusion in the trial.
  9. Pregnancy, breast feeding, unwillingness to keeping to contraception method during the study.
  10. Drug addiction, alcohol usage in the amount over 2 units of alcohol per day.
  11. Patients, who from investigator's point o view, will fail to comply with the observation requirements of the trial or with the intake regimen of the investigated medicines.
  12. Participation in other clinical trials in the course of 1 month prior to the inclusion in the trial.
  13. The patient is related to the research personnel of the investigative site, who are directly involved in the trial or are the immediate relative of the reseacher. The immediate relatives includes husband / wife, parents, children, brothers (or sisters), regardless of whether they are natural or adopted.
  14. The patient works for OOO "NPF "Materia Medica Holding" (i.e. is the company's employee, temporary contract worker or designated official responsible for carrying out the research) or the immediate relative.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Russian Federation
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01804946
Other Study ID Numbers  ICMJE MMH-ER-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Materia Medica Holding
Study Sponsor  ICMJE Materia Medica Holding
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Mikhail Putilovskiy, MD, PhD Materia Medica Holding
PRS Account Materia Medica Holding
Verification Date March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP