Comparative Clinical Trial of Efficiency and Safety of Ergoferon Versus Oseltamivir in Treatment of Influenza
Overview[ - collapse ][ - ]
| Purpose | The purpose of this study is: - to assess efficiency of Ergoferon for treatment of influenza; - to assess safety of Ergoferon for treatment of influenza; - to compare efficiency of Ergoferon and Oseltamivir for treatment of influenza. |
|---|---|
| Condition | Influenza |
| Intervention | Drug: Ergoferon Drug: Oseltamivir |
| Phase | Phase 4 |
| Sponsor | Materia Medica Holding |
| Responsible Party | Materia Medica Holding |
| ClinicalTrials.gov Identifier | NCT01850446 |
| First Received | April 30, 2013 |
| Last Updated | February 27, 2014 |
| Last verified | May 2013 |
Tracking Information[ + expand ][ + ]
| First Received Date | April 30, 2013 |
|---|---|
| Last Updated Date | February 27, 2014 |
| Start Date | May 2013 |
| Estimated Primary Completion Date | June 2015 |
| Current Primary Outcome Measures | Proportion of patient demonstrating recovery/ improvement in health [Time Frame: On day 2, 3, 4 and 5 of the treatment] [Designated as safety issue: No]Based on the results of objective examination conducted by a physician; Recovery criteria: body temperature ≤37.0° C + lack of symptoms; Improvement criteria: body temperature ≤37.2 ° C + total intensity of all symptoms (except for fever index) ≤2 scores. |
| Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
| Brief Title | Comparative Clinical Trial of Efficiency and Safety of Ergoferon Versus Oseltamivir in Treatment of Influenza |
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| Official Title | Comparative Parallel-group Randomized Clinical Trial of Efficiency and Safety of Ergoferon Versus Oseltamivir in Treatment of Influenza |
| Brief Summary | The purpose of this study is: - to assess efficiency of Ergoferon for treatment of influenza; - to assess safety of Ergoferon for treatment of influenza; - to compare efficiency of Ergoferon and Oseltamivir for treatment of influenza. |
| Detailed Description | The overall duration of a patient participation in the trial is 6 days (screening/randomization/therapy onset - day 1; study therapy period - day 1-5; follow-up period - day 6). |
| Study Type | Interventional |
| Study Phase | Phase 4 |
| Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment |
| Condition | Influenza |
| Intervention | Drug: Ergoferon Safety and Efficiency Drug: Oseltamivir Safety and Efficiency Other Names: Tamiflu |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Active, not recruiting |
|---|---|
| Estimated Enrollment | 150 |
| Estimated Completion Date | June 2015 |
| Estimated Primary Completion Date | March 2015 |
| Eligibility Criteria | Inclusion Criteria: 1. Patients aged from 18 to 70 years inclusively. 2. Patients, who were admitted to hospital within 48 hours from the onset of influenza signs. 3. Patients with body temperature ≥37,8°C when visiting a doctor + intensity of influenza symptoms ≥4 score (presence of at least 1 general symptom ≥2 scores and 1 nasal/ throat/ chest symptom ≥ 2 scores or greater number of symptoms with the intensity ≥1 score). 4. Diagnosed influenza confirmed by express diagnostics (OSOM Influenza A&B Test). 5. The possibility to start therapy within 48 hours after the onset of the first symptoms of influenza. 6. Usage of contraceptive methods by both gender patients of reproductive age during the trial and within 30 days after ending the participation in the trial. 7. Availability of signed patient information sheet (Informed Consent form) for participation in the clinical trial. Exclusion Criteria: 1. Suspected pneumonia. 2. Suspected initial manifestations of diseases that have symptoms similar to influenza symptoms (other acute respiratory and infectious diseases, influenza-like syndrome at the onset of systemic connective tissue disorders, oncohematology and other pathology). 3. Patients requiring competitive antiviral drugs, which are prohibited during this trial. 4. Medical history of primary and secondary immune deficiency: a) lymphoid system immunodeficiency (T-cell and/or B-cell immunity chain, immunodeficiency with predominant antibody deficiency); b) phagocyte deficiency; c) complement factors deficiency; d) combined immunodeficiency including AIDS induced by HIV infection; toxic, autoimmune, infectious, radial panleukopenia syndrome; general lymphocytopenia syndrome; syndrome of lymphocyte polyclonal activation; postsplenectomia syndrome; congenital asplenia; syndrome of immune complexes pathology associated with infectious, allergic and autoimmune diseases. 5. Medical history of sarcoidosis. 6. Oncological disease/suspected oncological disease. 7. Exacerbation or decompensation of chronic diseases affecting the patient's ability to participate in the clinical trial. 8. Medical history of polyvalent allergy. 9. Allergy/ intolerance to any of the components of medications used in influenza treatment. 10. Impaired glucose tolerance, type 1 and 2 diabetes mellitus. 11. Malabsorption syndrome, including congenital or acquired lactose deficiency or any other disaccharide deficiency. 12. Exacerbation or decompensation of chronic diseases affecting patient's ability to participate in the trial. 13. Pregnancy and breast feeding. 14. Drug addiction, alcohol usage in the amount exceeding 2 units of alcohol per day, mental disorders. 15. Intake of medicines listed in the section "Prohibited concomitant treatment" for 1 month prior to the inclusion in the trial. 16. Patients, who from the 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. 17. Participation in other clinical trials in the course of 1 month prior to the inclusion in the trial. 18. Patient is related to the research personnel of the investigative site, who are directly involved in the trial or are the immediate family member of the researcher. The immediate family members includes husband/wife, parents, children or brothers (or sisters), regardless of whether they are natural or adopted. 19. Patient works for OOO "NPF "Materia Medica Holding" (i.e. is the company's employee, temporary contract worker or appointed official responsible for the carrying out the research) or the immediate relative. - |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | Russian Federation |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01850446 |
|---|---|
| Other Study ID Numbers | MMH-ER-003 |
| Has Data Monitoring Committee | No |
| Information Provided By | Materia Medica Holding |
| Study Sponsor | Materia Medica Holding |
| Collaborators | Not Provided |
| Investigators | Not Provided |
| Verification Date | May 2013 |
Locations[ + expand ][ + ]
| Federal State Budgetary Military Educational Institution of Higher Professional Education "Military-Medicine Academy named after S. M. Kirov" of Ministry of Defence of Russian Federation | St. Petersburg, Russian Federation, 194044 |
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