ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Influenza
Interventions Drug: Ergoferon
Drug: Oseltamivir
Enrollment 161
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ergoferon Group (EG) Oseltamivir Group (OG)
Hide Arm/Group Description Adults aged 18 to 60 years were on the treatment regimen with Ergoferon for 5 days. 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 t.i.d. Adults aged 18 to 60 years were on Oseltamivir for 5 days (75 mg b.i.d.).
Period Title: Overall Study
Started 81 80
Completed 79 76
Not Completed 2 4
Reason Not Completed
Protocol Violation             1             0
Adverse Event             0             1
Insufficient data available             0             1
Do not meet inclusion criteria             1             2
Arm/Group Title Ergoferon Group (EG) Oseltamivir Group (OG) Total
Hide Arm/Group Description

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.

Ergoferon: Safety and Efficiency of Ergoferon in treatment of Influenza

Oseltamivir(Tamiflu): Safety and Efficiency in treatment of Influenza Total of all reporting groups
Overall Number of Baseline Participants 81 80 161
Hide Baseline Analysis Population Description
FAS included 78 patients per group: 5 patients excluded with the entry criteria violations (3, EG; 1, OG) and the lack of data (1, OG). PPSet contained 75 patients in EG and 72 ones in OG: 9 were excluded due to protocol violation (3, EG; 2, OG), the failure to satisfy not major entry criteria (3, OG) and due to assigning a prohibited drug (1, OG).
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 81 participants 80 participants 161 participants
34.5  (11.6) 34.9  (12.6) 34.7  (12.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 81 participants 80 participants 161 participants
Female
49
  60.5%
55
  68.8%
104
  64.6%
Male
32
  39.5%
25
  31.3%
57
  35.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Russian Federation Number Analyzed 81 participants 80 participants 161 participants
81 80 161
1.Primary Outcome
Title Percentage of Patients With Normal Body Temperature
Hide Description Axillary temperature (morning and evening) decline to or below 37.0 ºС (without subsequent increase during ≥24 h)
Time Frame Day 1 to Day 5
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Per Protocol (PP) set includes subjects received full per protocol therapy, completed all scheduled visits and had no substantial deviations from the protocol. Since PP-analysis and ITT-analysis demonstrated similar (confirmative) results the results of PP-analysis are presented.
Arm/Group Title Ergoferon Group (EG) Oseltamivir Goup (OG)
Hide Arm/Group Description:

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.

Ergoferon: Safety and Efficiency of Ergoferon in treatment of Influenza

Oseltamivir(Tamiflu): Safety and Efficiency in treatment of Influenza
Overall Number of Participants Analyzed 75 72
Measure Type: Number
Unit of Measure: Percentage of participants
Evening, Day 1 4 1
Evening, Day 2 15 15
Evening, Day 3 41 43
Evening, Day 4 68 72
Evening, Day 5 84 88
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ergoferon Group (EG), Oseltamivir Goup (OG)
Comments PP set was analyzed
Type of Statistical Test Non-Inferiority or Equivalence
Comments The pre-determined margin of 20% of the control group effect was used.
Statistical Test of Hypothesis P-Value 0.05
Comments One-sided, p-value was adjusted for multiple comparisons using the adaptive Holm method
Method Wald method of Z statistics calculation
Comments Wald method of Z statistics computed a confidence interval of proportion difference.
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Patients With Resolution of Influenza Symptoms
Hide Description 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 Frame on the day 7 of the observation
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per Protocol set.
Arm/Group Title Ergoferon Group Oseltamivir Group
Hide Arm/Group Description:
Adults aged 18 to 60 years were on the treatment regimen with Ergoferon for 5 days. 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 t.i.d.
Adults aged 18 to 60 years were on Oseltamivir for 5 days (75 mg b.i.d.).
Overall Number of Participants Analyzed 75 72
Measure Type: Number
Unit of Measure: Percentage of participants
Fever 100 100
Common symptoms 61 64
Respiratory symptoms 83 76
All symptoms 47 49
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ergoferon Group, Oseltamivir Group
Comments PP set was analyzed
Type of Statistical Test Non-Inferiority or Equivalence
Comments The pre-determined margin of 20% of the control group effect was used.
Statistical Test of Hypothesis P-Value <0.05
Comments One-sided, p-value was adjusted for multiple comparisons using the adaptive Holm method
Method Wald method of Z statistics calculation
Comments Wald method of Z statistics computed a confidence interval of proportion difference.
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Time to Resolution of the Influenza
Hide Description

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.

Time Frame Day 1 to Day 7
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per Protocol set
Arm/Group Title Ergoferon Group Oseltamivir Group
Hide Arm/Group Description:
Adults aged 18 to 60 years were on the treatment regimen with Ergoferon for 5 days. 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 t.i.d.
Adults aged 18 to 60 years were on Oseltamivir for 5 days (75 mg b.i.d.).
Overall Number of Participants Analyzed 75 72
Mean (Standard Deviation)
Unit of Measure: Days
Fever 2.1  (1.4) 2.3  (1.6)
Common symptoms 2.6  (2.2) 2.4  (2.1)
Respiratory symptoms 2.7  (2.5) 2.6  (2.6)
All influenza symptoms 2.6  (2.3) 2.5  (2.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ergoferon Group, Oseltamivir Group
Comments PP set was analyzed
Type of Statistical Test Non-Inferiority or Equivalence
Comments The clinically significant margin was assumed to be 0.2 of Oseltamivir effect
Statistical Test of Hypothesis P-Value <0.05
Comments To adjust for multiple comparisons, the adaptive Holm method was used as a way to control type 1 error
Method t-test, 1 sided
Comments Means were compared using the modified two-sample Student t-test including computation of a confidence interval for a difference between means
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Mean Body Temperature
Hide Description The axillary temperature was assessed during a physical examination at Day 1, 3 and 7; axillary temperature was assessed in degrees (Celsius, °С)
Time Frame on days 1, 3 and 7 of the observation
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per Protocol set
Arm/Group Title Ergoferon Group Oseltamivir Group
Hide Arm/Group Description:
Adults aged 18 to 60 years were on the treatment regimen with Ergoferon for 5 days. 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 t.i.d.
Adults aged 18 to 60 years were on Oseltamivir for 5 days (75 mg b.i.d.).
Overall Number of Participants Analyzed 75 72
Mean (Standard Deviation)
Unit of Measure: °C
Axillary temperature, Day 1 38.3  (0.4) 38.3  (0.4)
Axillary temperature, Day 3 37.0  (0.5) 37.0  (0.5)
Axillary temperature, Day 7 36.5  (0.2) 36.6  (0.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ergoferon Group, Oseltamivir Group
Comments PP set was analyzed
Type of Statistical Test Non-Inferiority or Equivalence
Comments The clinically significant margin was assumed to be 0.2°C
Statistical Test of Hypothesis P-Value <0.05
Comments To adjust for multiple comparisons, the adaptive Holm method was used as a way to control type 1 error
Method t-test, 1 sided
Comments Means were compared using the modified two-sample Student t-test including computation of a confidence interval for a difference between means.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0
Parameter Dispersion
Type: Standard Deviation
Value: 0.5
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Severity of Influenza Symptoms (Total Score of the Common Symptoms and Respiratory Symptoms)
Hide Description 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)
Time Frame on days 1, 3 and 7 of the observation
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per Protocol set
Arm/Group Title Ergoferon Group Oseltamivir Group
Hide Arm/Group Description:
Adults aged 18 to 60 years were on the treatment regimen with Ergoferon for 5 days. 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 t.i.d.
Adults aged 18 to 60 years were on Oseltamivir for 5 days (75 mg b.i.d.).
Overall Number of Participants Analyzed 75 72
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Common symptoms, Day 1 19.0  (6.7) 18.6  (6.3)
Common symptoms, Day 3 9.2  (5.1) 7.8  (4.3)
Common symptoms, Day 7 2.3  (2.7) 1.9  (2.3)
Respiratory symptoms, Day 1 6.1  (3.7) 5.9  (3.6)
Respiratory symptoms, Day 3 4.3  (2.4) 4.0  (2.7)
Respiratory symptoms, Day 7 1.3  (1.5) 1.4  (1.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ergoferon Group, Oseltamivir Group
Comments PP set was analyzed
Type of Statistical Test Non-Inferiority or Equivalence
Comments The margin of no clinical importance was assumed to be 0.5 point or less to assess any symptom based on 4 point scale.
Statistical Test of Hypothesis P-Value <0.05
Comments To adjust for multiple comparisons the adaptive Holm method was used as a way to control type 1 error
Method t-test, 1 sided
Comments Means were compared using the modified two-sample Student t-test including computation of a confidence interval for a difference between means
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0
Estimation Comments [Not Specified]
6.Secondary Outcome
Title The Number of the Antipyretic Intake
Hide Description A subject recorded the number of antipyretic intake in patient diary.
Time Frame Day 1 to Day 5
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per Protocol set
Arm/Group Title Ergoferon Group Oseltamivir Group
Hide Arm/Group Description:
Adults aged 18 to 60 years were on the treatment regimen with Ergoferon for 5 days. 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 t.i.d.
Adults aged 18 to 60 years were on Oseltamivir for 5 days (75 mg b.i.d.).
Overall Number of Participants Analyzed 75 72
Mean (Standard Deviation)
Unit of Measure: Number of Doses
Day 1 0.65  (0.48) 0.72  (0.45)
Day 2 0.40  (0.49) 0.49  (0.50)
Day 3 0.19  (0.39) 0.15  (0.36)
Day 4 0.01  (0.12) 0.03  (0.17)
Day 5 0.00  (0.00) 0.01  (0.12)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ergoferon Group, Oseltamivir Group
Comments PP set was analyzed
Type of Statistical Test Non-Inferiority or Equivalence
Comments To compare the number of antipyretic intake the margin of no clinical importance was assumed to be 0.2
Statistical Test of Hypothesis P-Value <0.05
Comments To adjust for multiple comparisons, the adaptive Holm method was used as a way to control type 1 error
Method t-test, 1 sided
Comments Means were compared using the modified two-sample Student t-test including computation of a confidence interval for a difference between means
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0
Parameter Dispersion
Type: Standard Deviation
Value: 0.5
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Change in the Patient’s Quality of Life.
Hide Description 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).
Time Frame Day 7 vs. Day 1
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per Protocol set
Arm/Group Title Ergoferon Group Oseltamivir Group
Hide Arm/Group Description:
Adults aged 18 to 60 years were on the treatment regimen with Ergoferon for 5 days. 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 t.i.d.
Adults aged 18 to 60 years were on Oseltamivir for 5 days (75 mg b.i.d.).
Overall Number of Participants Analyzed 75 72
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Day 1 9.5  (1.9) 9.4  (2.2)
Day 7 5.4  (0.9) 5.4  (0.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ergoferon Group, Oseltamivir Group
Comments PP set was analyzed
Type of Statistical Test Non-Inferiority or Equivalence
Comments To compare the quality of life total score the margin of no clinical importance was assumed to be 0.2 of Oseltamivir group value
Statistical Test of Hypothesis P-Value <0.05
Comments To adjust for multiple comparisons, the adaptive Holm method was used as a way to control type 1 error
Method t-test, 1 sided
Comments The changes of means (Day 7 vs Day 1) were compared using the modified two-sample Student t-test including computation of a confidence interval
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0
Parameter Dispersion
Type: Standard Deviation
Value: 2.2
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Change in the Subjective Health Status
Hide Description 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).
Time Frame Day 7 vs. Day 1
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per Protocol set
Arm/Group Title Ergoferon Group Oseltamivir Group
Hide Arm/Group Description:
Adults aged 18 to 60 years were on the treatment regimen with Ergoferon for 5 days. 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 t.i.d.
Adults aged 18 to 60 years were on Oseltamivir for 5 days (75 mg b.i.d.).
Overall Number of Participants Analyzed 75 72
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Day 1 41.6  (18.2) 46.2  (15.4)
Day 7 87.7  (10.7) 88.0  (10.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ergoferon Group, Oseltamivir Group
Comments PP set was analyzed
Type of Statistical Test Non-Inferiority or Equivalence
Comments To compare the patient subjective health status assessment the margin of no clinical importance was assumed to be 0.2 of Oseltamivir group value
Statistical Test of Hypothesis P-Value <0.05
Comments To adjust for multiple comparisons, the adaptive Holm method was used as a way to control type 1 error
Method t-test, 1 sided
Comments Changes of means (Day 7 vs Day 1) were compared using the modified two-sample Student t-test including computation of a confidence interval
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0
Parameter Dispersion
Type: Standard Deviation
Value: 18.2
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Percentage of Patients With Complications of the Influenza
Hide Description Pneumonia, sinusitis, otitis media are examples of the influenza complications
Time Frame Day 1 to Day 7
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per Protocol set
Arm/Group Title Ergoferon Group Oseltamivir Group
Hide Arm/Group Description:
Adults aged 18 to 60 years were on the treatment regimen with Ergoferon for 5 days. 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 t.i.d.
Adults aged 18 to 60 years were on Oseltamivir for 5 days (75 mg b.i.d.).
Overall Number of Participants Analyzed 75 72
Measure Type: Number
Unit of Measure: Percentage of participants
0 2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ergoferon Group, Oseltamivir Group
Comments PP set was analyzed
Type of Statistical Test Non-Inferiority or Equivalence
Comments The clinically significant difference (margin) between two percentages was assumed to be 20% or more of the effect of Oseltamivir
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method The Wald method of Z statistics calcul
Comments The Wald method of Z statistics calculation was performed including computation a confidence interval for a difference between proportions
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0
Estimation Comments [Not Specified]
Time Frame Adverse/Serious adverse events were registered from Day 1 to Day 7 and during 30 days after the end of the research
Adverse Event Reporting Description Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=161, Safety Population)
 
Arm/Group Title Ergoferon Group Oseltamivir Group
Hide Arm/Group Description Adults aged 18 to 60 years were on the treatment regimen with Ergoferon for 5 days. 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 t.i.d. Adults aged 18 to 60 years were on Oseltamivir for 5 days (75 mg b.i.d.).
All-Cause Mortality
Ergoferon Group Oseltamivir Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Ergoferon Group Oseltamivir Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/81 (0.00%)      0/80 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Ergoferon Group Oseltamivir Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   11/81 (13.58%)      15/80 (18.75%)    
Blood and lymphatic system disorders     
Monocytosis  1  1/81 (1.23%)  1 1/80 (1.25%)  1
Lymphocytosis  1  0/81 (0.00%)  0 1/80 (1.25%)  1
Thrombocytosis  1  1/81 (1.23%)  1 0/80 (0.00%)  0
Granulocytopenia  1  1/81 (1.23%)  1 1/80 (1.25%)  1
Leukopenia  1  1/81 (1.23%)  1 0/80 (0.00%)  0
Eosinophilia  1  0/81 (0.00%)  0 1/80 (1.25%)  1
Gastrointestinal disorders     
Nausea  1  0/81 (0.00%)  0 2/80 (2.50%)  2
Throat burning sensation of  1  1/81 (1.23%)  1 0/80 (0.00%)  0
Abnormal feces  1  1/81 (1.23%)  1 0/80 (0.00%)  0
Infections and infestations     
Acute pneumonia  1  0/81 (0.00%)  0 1/80 (1.25%)  1
Acute sinusitis  1  0/81 (0.00%)  0 1/80 (1.25%)  1
Investigations     
Urine white blood cells increased  1  2/81 (2.47%)  2 1/80 (1.25%)  1
Urine red blood cells increased  1  2/81 (2.47%)  2 2/80 (2.50%)  2
Crystal urine  1  1/81 (1.23%)  1 0/80 (0.00%)  0
Bacteria urine  1  2/81 (2.47%)  2 1/80 (1.25%)  1
Specific gravity urine increased  1  0/81 (0.00%)  0 1/80 (1.25%)  1
Transaminases increased  1  1/81 (1.23%)  1 1/80 (1.25%)  1
Bilirubin increased  1  2/81 (2.47%)  2 0/80 (0.00%)  0
Blood monocytes increased  1  1/81 (1.23%)  1 0/80 (0.00%)  0
ESR increased  1  0/81 (0.00%)  0 1/80 (1.25%)  1
Psychiatric disorders     
Depression  1  0/81 (0.00%)  0 1/80 (1.25%)  1
Renal and urinary disorders     
Urine mucous  1  3/81 (3.70%)  3 1/80 (1.25%)  1
Proteinuria  1  4/81 (4.94%)  4 4/80 (5.00%)  4
Glycosuria  1  1/81 (1.23%)  1 0/80 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Difficulty breathing  1  0/81 (0.00%)  0 1/80 (1.25%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
 
Results Point of Contact
Name/Title: Mikhail Putilovskiy, MD, PhD, Head of department of clinical trials
Organization: Materia Medica Holding
Phone: +74952761575 ext 302
Responsible Party: Materia Medica Holding
ClinicalTrials.gov Identifier: NCT01804946     History of Changes
Other Study ID Numbers: MMH-ER-001
First Submitted: March 4, 2013
First Posted: March 5, 2013
Results First Submitted: April 13, 2015
Results First Posted: June 23, 2015
Last Update Posted: June 23, 2015