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.
Verified January 2013 by Materia Medica Holding
Sponsor:
Materia Medica Holding
Information provided by (Responsible Party):
Materia Medica Holding
ClinicalTrials.gov Identifier:
NCT01765920
First received: January 9, 2013
Last updated: NA
Last verified: January 2013
History: No changes posted
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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 |
Resource links provided by NLM:
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:
- Patients of both sexes aged from 18 to 60 inclusively.
- Patients who consulted a doctor during the increase of seasonal incidence within 24 hours after the onset of acute upper respiratory tract infection.
- Body temperature at least 37.8 °С at the moment of examination by the doctor.
- Presence of two or more moderate level symptoms or three or more mild level symptoms according to the CCQ scale.
- The possibility to start therapy within 24 hours after the onset of the first symptoms of acute upper respiratory tract infection.
- 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.
- Availability of information sheet (informed consent form for taking part in the clinical trial) signed by the patient.
Exclusion Criteria:
- Suspected invasive bacterial infection or presence of severe disease requiring use of antibacterial drugs (including sulfanilamides).
- 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).
- Exacerbation or decompensation of chronic diseases affecting the patient's ability to participate in a 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 examined medicine).
- Intake of medicines listed in the section "Prohibited concomitant treatment" for 1 month prior to participation in the trial.
- Pregnancy, breast feeding.
- Drugs usage, alcohol usage in the amount over 2 units of alcohol per day.
- Patients with mental disorders.
- 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.
- Participation in other clinical trials in the course of 3 months prior to inclusion into the present trial.
- Other factors, which hinder the patient's participation in the trial (for example, planned trips or business trips).
- 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.
- 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
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" | Not yet recruiting |
| Chelyabinsk, Russian Federation, 454091 | |
| Contact: Ulia Shapovalova, MD | |
| Principal Investigator: Ulia Shapovalova, MD | |
| State Budgetary Educational Institution of Higher Professional Education "Kazan State Medical University" | Not yet 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 | Not yet recruiting |
| Moscow, Russian Federation, 105064 | |
| Contact: Mikhail Kostinov, Prof | |
| Principal Investigator: Mikhail Kostinov, Prof | |
| Federal State Budgetary Institution "Polyclinic № 3" of Affairs Management Department of the President of Russian Federation | Not yet recruiting |
| Moscow, Russian Federation, 129090 | |
| Contact: Elena Minina, MD | |
| Principal Investigator: Elena Minina, MD | |
| LLC "Panacea Clinic" | Not yet recruiting |
| Moscow, Russian Federation, 117630 | |
| Contact: Alexander Rosanov, MD | |
| Principal Investigator: Alexander Rosanov, 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 | |
| State Budgetary Educational Institution of Higher Professional Education "St. Petersburg State Medical University named after I.P. Pavlov" | Not yet recruiting |
| St. Petersburg, Russian Federation, 197022 | |
| Contact: Mikhail Ilkovich, Prof | |
| Principal Investigator: Mikhail Ilkovich, Prof | |
| St. Petersburg State Budgetary Health Care Institution "Сity Polyclinic № 4" | Recruiting |
| St. Petersburg, Russian Federation, 199178 | |
| Contact: Susanna Kharit, Prof | |
| Principal Investigator: Susanna Kharit, Prof | |
| St. Petersburg State Budgetary Health Care Institution "Medical Exercises Dispensary" of Krasnogvardeysky District | Recruiting |
| St. Petersburg, Russian Federation, 195112 | |
| Contact: Alexander Sherenkov, MD | |
| Principal Investigator: Alexander Sherenkov, MD | |
| State Budgetary Educational Institution of Higher Professional Education "St. Petersburg State Medical University named after I.P. Pavlov" | Not yet recruiting |
| St. Petersburg, Russian Federation, 197002 | |
| Contact: Andrey Akopov, Prof | |
| Principal Investigator: Andrey Akopov, MD | |
| St. Petersburg State Budgetary Health Care Institution "Сity Polyclinic № 117" | Recruiting |
| St. Petersburg, Russian Federation, 194358 | |
| Contact: Diana Alpenidze, MD | |
| Principal Investigator: Diana Alpenidze, MD | |
| 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: | January 9, 2013 |
| Health Authority: | Russia: Ministry of Health of the Russian Federation |
Additional relevant MeSH terms:
|
Respiratory Tract Infections Common Cold Infection Respiratory Tract Diseases |
Picornaviridae Infections RNA Virus Infections Virus Diseases |
ClinicalTrials.gov processed this record on May 16, 2013