Clinical Trial of Safety and Clinical Efficacy of Ergoferon in Liquid Dosage Form in Treatment of Acute Upper Respiratory Tract Infections in Children
Sponsor
Materia Medica Holding (Industry)
Overall Status
Completed
CT.gov ID
NCT01843842
Collaborator
(none)
306
11
2
23
27.8
1.2
Study Details
Study Description
Brief Summary
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 children;
-
to assess clinical efficacy of the liquid dosage form of Ergoferon for treatment acute upper respiratory tract infections in children.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
The overall duration of a patient's participation in the trial is 6 days (screening/randomization, therapy onset - day 1; study therapy period - 5 days; follow-up period-1 day).
Study Design
Study Type:
Interventional
Actual Enrollment
:
306 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Multicentre Double-blind Placebo-controlled Parallel-group Randomized Clinical Trial of Safety and Clinical Efficacy of Ergoferon in Liquid Dosage Form in Treatment of Acute Upper Respiratory Tract Infections in Children
Study Start Date
:
Apr 1, 2013
Actual Primary Completion Date
:
Mar 1, 2015
Actual Study Completion Date
:
Mar 1, 2015
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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
|
Outcome Measures
Primary Outcome Measures
- Percentage of Patients With Recovery/Improvement in Health on Days 2, 3 and 4 of Observation (Based on Patient Diary Data) [On day 2, 3 and 4 of observation]
Based on the data mentioned in a patient's diary
Secondary Outcome Measures
- Dynamics of Fever (Changes in Body Temperature on 2, 3, 4, 5 Days of Observation in Comparison With the Baseline) [baseline and days 2, 3, 4 and 5 of observation]
- Percentage of Patients With Normal Body Temperature (≤37.0ºС) [On day 2, 3, 4, 5 of observation]
Axillary temperature (morning and evening) decline to or below 37.0 ºС
- Severity of Clinical Manifestations of Acute Respiratory Infection (ARI) by Total Symptom Score on Day 3 of Observation (Based on the Results of Pediatrician's Examination) and on Days 2, 3, 4 and 5 of Observation (Based on Patient Diary Data) [on Days 2, 3, 4, 5 of Observation]
The Total Symptom Score (TSS) was based on the severity of each of acute respiratory infection (ARI) symptom. The TSS includes 13 symptoms: Body temperature / fever, Non-specific ARI symptoms (headache, chills, sweating, weakness, muscle pain, drowsiness), Nasal/Throat/Chest symptoms (Runny nose, Nasal congestion, Sneezing, Sore throat, Hoarseness, Cough, Chest pain/Tightness of the chest). The severity of Non-specific and Nasal/Throat/Chest symptom was scored on a symptom severity scale (0 = no symptoms; 1 = mild symptoms; 2 = moderate symptoms; 3 = severe symptoms). The Fever was scored on a symptom severity scale 0 = no symptom (≤37,30С); 1 = mild symptom (37,4-38,00С); 2 = moderate symptom (38,1-39,00); 3 = severe symptom (≥39,10С). Minimum score=0; maximum score=39. The severity of ARI symptoms was recorded: 1) by the doctors on the case record form on Day 3; 2) by one of the patient's parents/adopter on a diary card twice a day (morning and evening) on Days 2-5.
- Duration of Acute Respiratory Infection Symptoms (Fever, Non-specific Symptoms and Nasal/ Throat/ Chest Symptoms) Based on Patient Diary Data [baseline and days 2, 3, 4 and 5 of observation]
Acute respiratory infection (ARI) symptoms include 13 symptoms: Body temperature / fever, Non-specific ARI symptoms (headache, chills, sweating, weakness, muscle pain, drowsiness), Nasal/Throat/Chest symptoms (Runny nose, Nasal congestion, Sneezing, Sore throat, Hoarseness, Cough, Chest pain/Tightness of the chest). The ARI symptoms was recorded by one of the patient's parents/adopter on a diary card twice a day (morning and evening) on Days 1-5.
- Severity of the Disease Within 6 Days Was Assessed Using the "Area Under the Curve" for the Total Symptom Score (TSS) [On days 1-6 of observation]
The Total Symptom Score (TSS) was based on the severity of each of acute respiratory infection (ARI) symptom. The TSS includes 13 symptoms: Body temperature / fever, Non-specific ARI symptoms (headache, chills, sweating, weakness, muscle pain, drowsiness), Nasal/Throat/Chest symptoms (Runny nose, Nasal congestion, Sneezing, Sore throat, Hoarseness, Cough, Chest pain/Tightness of the chest). The severity of Non-specific and Nasal/Throat/Chest symptom was scored on a symptom severity scale (0 = no symptoms; 1 = mild symptoms; 2 = moderate symptoms; 3 = severe symptoms). The Fever was scored on a symptom severity scale 0 = no symptom (≤37,30С); 1 = mild symptom (37,4-38,00С); 2 = moderate symptom (38,1-39,00); 3 = severe symptom (≥39,10С). Minimum score=0; maximum score=39. The severity of ARI symptoms was recorded: 1) by the doctors on the case record form on Days 1, 3, 6; 2) by one of the patient's parents/adopter on a diary card twice a day (morning and evening) on Days 1-5.
- Number of Intakes of Antipyretics if Indicated [On day 1, 2, 3, 4 and 5 of the treatment]
Based on data mentioned in a patient's diary
- Percentage of Patients With Exacerbation of the Disease Course [On days 1-6 of observation]
The development of disease complications requiring antibiotics administration or hospitalization
Eligibility Criteria
Criteria
Ages Eligible for Study:
3 Years
to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Patients of both sexes aged over 3 years and under 18 years.
-
Patients who consulted a doctor within 24 hours after the onset of acute respiratory infection (body temperature no less than 38.0°C when visiting a doctor + intensity of symptoms ≥ 4 scores (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) during seasonal morbidity.
-
The possibility to start therapy within 24 hours after the onset of the first symptoms of acute respiratory infection.
-
Usage of contraceptive methods by sexually active teenagers of both sexes during the trial and within 30 days after ending of the participation in the trial.
-
Availability of information sheet (Informed Consent form) for parents/adopters of patient for participation in the clinical trial, Version 2.1 or Version 2.2, signed by one parent/adopter of patient. For patients over 14 years - availability of information sheet (Informed Consent form) for participation in the clinical trial, Version 2.1 or Version 2.2, signed by a patient and one parent/adopter of patient.
Exclusion Criteria:
-
Suspected bacterial infection or presence of a severe disease requiring use of antibacterial drugs (including sulfanilamides).
-
Suspected initial manifestations of diseases that have symptoms similar to acute respiratory infection (other infectious diseases, influenza-like syndrome at the onset of systemic connective tissue disorders, oncohematology and other pathology).
-
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.
-
Medical history of sarcoidosis.
-
Oncological diseases.
-
Exacebration or decompensation of chronic diseases affecting the patient's ability to participate in the clinical trial.
-
Medical history of polyvalent allergy.
-
Allergy/ intolerance to any of the components of medications used in the treatment.
-
Impaired glucose tolerance, diabetes mellitus.
-
Hereditary fructose intolerance (as the study drug contains maltitol).
-
Intake of medicines listed in the section "Prohibited concomitant treatment" for 1 month prior to the inclusion in the trial.
-
Pregnancy, unwillingness of sexually active female patients to use of contraceptive methods during the study.
-
Drug addiction, alcohol usage in the amount 2 units of alcohol per day on the part of patient's parents/adopters.
-
Mental disorders of patient or of patient's parents/adopters.
-
Patient's parents/ adopters, 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 the inclusion in the trial.
-
Patient's parent/adopter is related to the research personnel of the investigative site, who are directly involved in the trial or are the immediate relative of the researcher. The immediate relatives includes husband/wife, parents, children or brothers (or sisters), regardless of whether they are natural or adopted.
-
Patient's parent/adopter 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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Municipal Institution "Child Health City Hospital №11" | Ekaterinburg | Russian Federation | 620028 | |
| 2 | State Educational Institution of Higher Professional Education "Moscow State Medical Academy named after I.M. Sechenov" | Moscow | Russian Federation | 119992 | |
| 3 | State Budgetary Educational Institution of Higher Professional Education Novosibirsk State Medical University of Ministry of Health of Russian Federation | Novosibirsk | Russian Federation | 630091 | |
| 4 | Municipal Health Care Institution "City Child Health Clinical Polyclinic №5" | Perm | Russian Federation | 614066 | |
| 5 | St. Peterburg State Health Care Institution "Child Health City Hospital №45 of the Nevsky Region" | St. Peterburg | Russian Federation | 193312 | |
| 6 | State Budgetary Health Care Institution "Сity Child Health Polyclinic №44" | St. Petersburg | Russian Federation | 191144 | |
| 7 | St. Petersburg State Budgetary Health Care Institution "Сity Polyclinic №44" | St. Petersburg | Russian Federation | 192212 | |
| 8 | State Budgetary Educational Institution of Higher Professional Education "St. Petersburg State Pediatric Medical Academy" of Ministry of Health of Russian Federation | St. Petersburg | Russian Federation | 194100 | |
| 9 | State Health Care Institution "Child Health City Hospital №22" | St. Petersburg | Russian Federation | 196650 | |
| 10 | Limited Liability Company "Alliance Biomedical-Russian group" | St.Petersburg | Russian Federation | 194356 | |
| 11 | State Budgetary Educational Institution of Higher Professional Education " Yaroslavl State Medical Academy" of Ministry of Health | Yaroslavl | Russian Federation | 150000 |
Sponsors and Collaborators
- Materia Medica Holding
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Materia Medica Holding
ClinicalTrials.gov Identifier:
NCT01843842
Other Study ID Numbers:
- MMH-ER-007
First Posted:
May 1, 2013
Last Update Posted:
Nov 29, 2018
Last Verified:
Nov 1, 2018
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Ergoferon in Liquid Dosage Form | Placebo |
|---|---|---|
| Arm/Group Description | Children aged 3 to 18 years were on the treatment regimen with Ergoferon in Liquid Dosage Form for 5 days. 1 dosing spoon (5 ml) per 1 intake: on day 1 of the treatment 8 dosing spoons (1 dosing spoon every 30 minutes for the first 2 hours, then 1 dosing spoon 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 dosing spoon tablet 3 times a day. | Children aged 3 to 18 years were on the treatment regimen with Placebo for 5 days. 1 dosing spoon (5 ml) per 1 intake: on day 1 of the treatment 8 dosing spoons (1 dosing spoon every 30 minutes for the first 2 hours, then 1 dosing spoon 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 dosing spoon tablet 3 times a day. |
| Period Title: Overall Study | ||
| STARTED | 154 | 152 |
| COMPLETED | 153 | 151 |
| NOT COMPLETED | 1 | 1 |
Baseline Characteristics
| Arm/Group Title | Ergoferon in Liquid Dosage Form | Placebo | Total |
|---|---|---|---|
| Arm/Group Description | 1 dosing spoon (5 ml) per 1 intake: on day 1 of the treatment 8 dosing spoons (1 dosing spoon every 30 minutes for the first 2 hours, then 1 dosing spoon 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 dosing spoon tablet 3 times a day | 1 dosing spoon (5 ml) per 1 intake: on day 1 of the treatment 8 dosing spoons (1 dosing spoon every 30 minutes for the first 2 hours, then 1 dosing spoon 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 dosing spoon tablet 3 times a day | Total of all reporting groups |
| Overall Participants | 154 | 152 | 306 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
9.8
(4.1)
|
10.2
(4.2)
|
10.0
(4.1)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
67
43.5%
|
80
52.6%
|
147
48%
|
| Male |
87
56.5%
|
72
47.4%
|
159
52%
|
| Region of Enrollment (Count of Participants) | |||
| Russia |
154
100%
|
152
100%
|
306
100%
|
Outcome Measures
| Title | Percentage of Patients With Recovery/Improvement in Health on Days 2, 3 and 4 of Observation (Based on Patient Diary Data) |
|---|---|
| Description | Based on the data mentioned in a patient's diary |
| Time Frame | On day 2, 3 and 4 of observation |
Outcome Measure Data
| Analysis Population Description |
|---|
| Per Protocol set |
| Arm/Group Title | Ergoferon in Liquid Dosage Form | Placebo |
|---|---|---|
| Arm/Group Description | Children aged 3 to 18 years were on the treatment regimen with Ergoferon in Liquid Dosage Form for 5 days. 1 dosing spoon (5 ml) per 1 intake: on day 1 of the treatment 8 dosing spoons (1 dosing spoon every 30 minutes for the first 2 hours, then 1 dosing spoon 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 dosing spoon tablet 3 times a day. | Children aged 3 to 18 years were on the treatment regimen with Placebo for 5 days. 1 dosing spoon (5 ml) per 1 intake: on day 1 of the treatment 8 dosing spoons (1 dosing spoon every 30 minutes for the first 2 hours, then 1 dosing spoon 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 dosing spoon tablet 3 times a day. |
| Measure Participants | 145 | 148 |
| Day 2 |
9
5.8%
|
1
0.7%
|
| Day 3 |
21
13.6%
|
11
7.2%
|
| Day 4 |
44
28.6%
|
33
21.7%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Ergoferon in Liquid Dosage Form, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.016 |
| Comments | ||
| Method | Global Test Statistic | |
| Comments | See O'Brien 1984, Pocock 1997. | |
| Title | Dynamics of Fever (Changes in Body Temperature on 2, 3, 4, 5 Days of Observation in Comparison With the Baseline) |
|---|---|
| Description | |
| Time Frame | baseline and days 2, 3, 4 and 5 of observation |
Outcome Measure Data
| Analysis Population Description |
|---|
| Per Protocol set. The morning temperature in 13 patients (7 in the Ergoferon group and 6 in the placebo group) was excluded from the analysis due to mistakes in diaries. |
| Arm/Group Title | Ergoferon in Liquid Dosage Form | Placebo |
|---|---|---|
| Arm/Group Description | Children aged 3 to 18 years were on the treatment regimen with Ergoferon in Liquid Dosage Form for 5 days. 1 dosing spoon (5 ml) per 1 intake: on day 1 of the treatment 8 dosing spoons (1 dosing spoon every 30 minutes for the first 2 hours, then 1 dosing spoon 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 dosing spoon tablet 3 times a day. | Children aged 3 to 18 years were on the treatment regimen with Placebo for 5 days. 1 dosing spoon (5 ml) per 1 intake: on day 1 of the treatment 8 dosing spoons (1 dosing spoon every 30 minutes for the first 2 hours, then 1 dosing spoon 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 dosing spoon tablet 3 times a day. |
| Measure Participants | 138 | 142 |
| Day 2, Morning |
-0.96
(0.55)
|
-0.79
(0.53)
|
| Day 3, Morning |
-1.49
(0.47)
|
-1.30
(0.50)
|
| Day 4, Morning |
-1.77
(0.41)
|
-1.69
(0.44)
|
| Day 5, Morning |
-1.90
(0.37)
|
-1.86
(0.38)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Ergoferon in Liquid Dosage Form, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Title | Percentage of Patients With Normal Body Temperature (≤37.0ºС) |
|---|---|
| Description | Axillary temperature (morning and evening) decline to or below 37.0 ºС |
| Time Frame | On day 2, 3, 4, 5 of observation |
Outcome Measure Data
| Analysis Population Description |
|---|
| Per Protocol set. |
| Arm/Group Title | Ergoferon in Liquid Dosage Form | Placebo |
|---|---|---|
| Arm/Group Description | Children aged 3 to 18 years were on the treatment regimen with Ergoferon in Liquid Dosage Form for 5 days. 1 dosing spoon (5 ml) per 1 intake: on day 1 of the treatment 8 dosing spoons (1 dosing spoon every 30 minutes for the first 2 hours, then 1 dosing spoon 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 dosing spoon tablet 3 times a day. | Children aged 3 to 18 years were on the treatment regimen with Placebo for 5 days. 1 dosing spoon (5 ml) per 1 intake: on day 1 of the treatment 8 dosing spoons (1 dosing spoon every 30 minutes for the first 2 hours, then 1 dosing spoon 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 dosing spoon tablet 3 times a day. |
| Measure Participants | 145 | 148 |
| Day 2, Morning |
21
13.6%
|
16
10.5%
|
| Day 2, Evening |
29
18.8%
|
22
14.5%
|
| Day 3, Morning |
68
44.2%
|
53
34.9%
|
| Day 3, Evening |
59
38.3%
|
51
33.6%
|
| Day 4, Morning |
89
57.8%
|
86
56.6%
|
| Day 4, Evening |
81
52.6%
|
78
51.3%
|
| Day 5, Morning |
98
63.6%
|
97
63.8%
|
| Day 5, Evening |
94
61%
|
95
62.5%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Ergoferon in Liquid Dosage Form, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | >0.05 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
| Title | Severity of Clinical Manifestations of Acute Respiratory Infection (ARI) by Total Symptom Score on Day 3 of Observation (Based on the Results of Pediatrician's Examination) and on Days 2, 3, 4 and 5 of Observation (Based on Patient Diary Data) |
|---|---|
| Description | The Total Symptom Score (TSS) was based on the severity of each of acute respiratory infection (ARI) symptom. The TSS includes 13 symptoms: Body temperature / fever, Non-specific ARI symptoms (headache, chills, sweating, weakness, muscle pain, drowsiness), Nasal/Throat/Chest symptoms (Runny nose, Nasal congestion, Sneezing, Sore throat, Hoarseness, Cough, Chest pain/Tightness of the chest). The severity of Non-specific and Nasal/Throat/Chest symptom was scored on a symptom severity scale (0 = no symptoms; 1 = mild symptoms; 2 = moderate symptoms; 3 = severe symptoms). The Fever was scored on a symptom severity scale 0 = no symptom (≤37,30С); 1 = mild symptom (37,4-38,00С); 2 = moderate symptom (38,1-39,00); 3 = severe symptom (≥39,10С). Minimum score=0; maximum score=39. The severity of ARI symptoms was recorded: 1) by the doctors on the case record form on Day 3; 2) by one of the patient's parents/adopter on a diary card twice a day (morning and evening) on Days 2-5. |
| Time Frame | on Days 2, 3, 4, 5 of Observation |
Outcome Measure Data
| Analysis Population Description |
|---|
| Per Protocol set |
| Arm/Group Title | Ergoferon in Liquid Dosage Form | Placebo |
|---|---|---|
| Arm/Group Description | Children aged 3 to 18 years were on the treatment regimen with Ergoferon in Liquid Dosage Form for 5 days. 1 dosing spoon (5 ml) per 1 intake: on day 1 of the treatment 8 dosing spoons (1 dosing spoon every 30 minutes for the first 2 hours, then 1 dosing spoon 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 dosing spoon tablet 3 times a day. | Children aged 3 to 18 years were on the treatment regimen with Placebo for 5 days. 1 dosing spoon (5 ml) per 1 intake: on day 1 of the treatment 8 dosing spoons (1 dosing spoon every 30 minutes for the first 2 hours, then 1 dosing spoon 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 dosing spoon tablet 3 times a day. |
| Measure Participants | 145 | 148 |
| Fever (Day 3, doctor's examination) |
0.3
(0.5)
|
0.4
(0.6)
|
| Non-specific (Day 3, doctor's examination) |
1.7
(1.8)
|
1.9
(1.8)
|
| Nasal/Throat/Chest (Day 3, doctor's examination) |
3.6
(2.2)
|
3.7
(2.1)
|
| All symptoms (Day 3, doctor's examination) |
5.5
(3.7)
|
6.0
(3.6)
|
| Fever (Day 2, patient diary data) |
0.8
(0.7)
|
1.0
(0.8)
|
| Non-specific (Day 2, patient diary data) |
3.3
(3.0)
|
4.1
(3.1)
|
| Nasal/Throat/Chest (Day 2, patient diary data) |
4.4
(2.8)
|
5.0
(2.8)
|
| All symptoms (Day 2, patient diary data) |
9.4
(6.1)
|
11.1
(6.3)
|
| Fever (Day 3, patient diary data) |
0.3
(0.5)
|
0.5
(0.6)
|
| Non-specific (Day 3, patient diary data) |
1.7
(1.9)
|
1.9
(1.8)
|
| Nasal/Throat/Chest (Day 3, patient diary data) |
3.3
(2.2)
|
3.6
(2.1)
|
| All symptoms (Day 3, patient diary data) |
5.6
(4.2)
|
6.4
(4.1)
|
| Fever (Day 4, patient diary data) |
0.1
(0.3)
|
0.1
(0.4)
|
| Non-specific (Day 4, patient diary data) |
0.6
(1.1)
|
0.8
(1.2)
|
| Nasal/Throat/Chest (Day 4, patient diary data) |
2.3
(2.0)
|
2.3
(1.4)
|
| All symptoms (Day 4, patient diary data) |
3.1
(2.9)
|
3.3
(2.5)
|
| Fever (Day 5, patient diary data) |
0.0
(0.2)
|
0.0
(0.2)
|
| Non-specific (Day 5, patient diary data) |
0.2
(0.8)
|
0.2
(0.6)
|
| Nasal/Throat/Chest (Day 5, patient diary data) |
1.3
(1.5)
|
1.3
(1.2)
|
| All symptoms (Day 5, patient diary data) |
1.6
(2.0)
|
1.6
(1.7)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Ergoferon in Liquid Dosage Form, Placebo |
|---|---|---|
| Comments | Fever (Day 3, doctor's examination) | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0283 |
| Comments | p-value is not adjusted for multiple comparisons | |
| Method | Kruskal-Wallis | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Ergoferon in Liquid Dosage Form, Placebo |
|---|---|---|
| Comments | Non-specific (Day 3, doctor's examination) | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3264 |
| Comments | ||
| Method | Kruskal-Wallis | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Ergoferon in Liquid Dosage Form, Placebo |
|---|---|---|
| Comments | Nasal/Throat/Chest (Day 3, doctor's examination) | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.7060 |
| Comments | ||
| Method | Kruskal-Wallis | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Ergoferon in Liquid Dosage Form, Placebo |
|---|---|---|
| Comments | All symptoms (Day 3, doctor's examination) | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.25 |
| Comments | ||
| Method | Kruskal-Wallis | |
| Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Ergoferon in Liquid Dosage Form, Placebo |
|---|---|---|
| Comments | Severity of clinical manifestations of acute respiratory infection (ARI) by Total Symptom Score on Days 2, 3, 4 and 5 of Observation (Based on Patient Diary Data) | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.244 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Title | Duration of Acute Respiratory Infection Symptoms (Fever, Non-specific Symptoms and Nasal/ Throat/ Chest Symptoms) Based on Patient Diary Data |
|---|---|
| Description | Acute respiratory infection (ARI) symptoms include 13 symptoms: Body temperature / fever, Non-specific ARI symptoms (headache, chills, sweating, weakness, muscle pain, drowsiness), Nasal/Throat/Chest symptoms (Runny nose, Nasal congestion, Sneezing, Sore throat, Hoarseness, Cough, Chest pain/Tightness of the chest). The ARI symptoms was recorded by one of the patient's parents/adopter on a diary card twice a day (morning and evening) on Days 1-5. |
| Time Frame | baseline and days 2, 3, 4 and 5 of observation |
Outcome Measure Data
| Analysis Population Description |
|---|
| Per Protocol set. |
| Arm/Group Title | Ergoferon in Liquid Dosage Form | Placebo |
|---|---|---|
| Arm/Group Description | Children aged 3 to 18 years were on the treatment regimen with Ergoferon in Liquid Dosage Form for 5 days. 1 dosing spoon (5 ml) per 1 intake: on day 1 of the treatment 8 dosing spoons (1 dosing spoon every 30 minutes for the first 2 hours, then 1 dosing spoon 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 dosing spoon tablet 3 times a day. | Children aged 3 to 18 years were on the treatment regimen with Placebo for 5 days. 1 dosing spoon (5 ml) per 1 intake: on day 1 of the treatment 8 dosing spoons (1 dosing spoon every 30 minutes for the first 2 hours, then 1 dosing spoon 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 dosing spoon tablet 3 times a day. |
| Measure Participants | 145 | 148 |
| Fever |
26.7
(22.9)
|
31.6
(23.9)
|
| Non-specific symptoms |
55.2
(31.0)
|
60.8
(30.5)
|
| Nasal/ throat/ chest symptoms |
84.0
(33.2)
|
88.9
(29.9)
|
| All symptoms |
86.0
(30.8)
|
91.1
(27.9)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Ergoferon in Liquid Dosage Form, Placebo |
|---|---|---|
| Comments | Duration of fever based on Patient Diary Data | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1158 |
| Comments | ||
| Method | Kruskal-Wallis | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Ergoferon in Liquid Dosage Form, Placebo |
|---|---|---|
| Comments | Duration of non-specific symptoms based on Patient Diary Data | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.5755 |
| Comments | ||
| Method | Kruskal-Wallis | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Ergoferon in Liquid Dosage Form, Placebo |
|---|---|---|
| Comments | Duration of nasal/ throat/ chest symptoms based on Patient Diary Data | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4331 |
| Comments | ||
| Method | Kruskal-Wallis | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Ergoferon in Liquid Dosage Form, Placebo |
|---|---|---|
| Comments | Duration of all acute respiratory infection symptoms (fever, non-specific symptoms and nasal/ throat/ chest symptoms) based on Patient Diary Data | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3560 |
| Comments | ||
| Method | Kruskal-Wallis | |
| Comments | ||
| Title | Severity of the Disease Within 6 Days Was Assessed Using the "Area Under the Curve" for the Total Symptom Score (TSS) |
|---|---|
| Description | The Total Symptom Score (TSS) was based on the severity of each of acute respiratory infection (ARI) symptom. The TSS includes 13 symptoms: Body temperature / fever, Non-specific ARI symptoms (headache, chills, sweating, weakness, muscle pain, drowsiness), Nasal/Throat/Chest symptoms (Runny nose, Nasal congestion, Sneezing, Sore throat, Hoarseness, Cough, Chest pain/Tightness of the chest). The severity of Non-specific and Nasal/Throat/Chest symptom was scored on a symptom severity scale (0 = no symptoms; 1 = mild symptoms; 2 = moderate symptoms; 3 = severe symptoms). The Fever was scored on a symptom severity scale 0 = no symptom (≤37,30С); 1 = mild symptom (37,4-38,00С); 2 = moderate symptom (38,1-39,00); 3 = severe symptom (≥39,10С). Minimum score=0; maximum score=39. The severity of ARI symptoms was recorded: 1) by the doctors on the case record form on Days 1, 3, 6; 2) by one of the patient's parents/adopter on a diary card twice a day (morning and evening) on Days 1-5. |
| Time Frame | On days 1-6 of observation |
Outcome Measure Data
| Analysis Population Description |
|---|
| Per Protocol set. |
| Arm/Group Title | Ergoferon in Liquid Dosage Form | Placebo |
|---|---|---|
| Arm/Group Description | Children aged 3 to 18 years were on the treatment regimen with Ergoferon in Liquid Dosage Form for 5 days. 1 dosing spoon (5 ml) per 1 intake: on day 1 of the treatment 8 dosing spoons (1 dosing spoon every 30 minutes for the first 2 hours, then 1 dosing spoon 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 dosing spoon tablet 3 times a day. | Children aged 3 to 18 years were on the treatment regimen with Placebo for 5 days. 1 dosing spoon (5 ml) per 1 intake: on day 1 of the treatment 8 dosing spoons (1 dosing spoon every 30 minutes for the first 2 hours, then 1 dosing spoon 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 dosing spoon tablet 3 times a day. |
| Measure Participants | 145 | 148 |
| Fever (Days 1, 3, 6 doctor's examination) |
1.3
(0.6)
|
1.5
(0.7)
|
| Non-specific (Days 1, 3, 6 doctor's examination) |
4.9
(3.0)
|
5.2
(2.6)
|
| Nasal/Throat/Chest (Days 1, 3, 6 doctor's examinat |
6.9
(3.6)
|
7.2
(3.3)
|
| All symptoms (Days 1, 3, 6 doctor's examination) |
13.1
(5.7)
|
13.9
(5.3)
|
| Fever (Days 1-5, patient diary data) |
2.1
(1.6)
|
2.6
(1.7)
|
| Non-specific (Days 1-5, patient diary data) |
8.7
(6.7)
|
10.1
(6.6)
|
| Nasal/Throat/Chest (Days 1-5, patient diary data) |
13.4
(8.0)
|
14.4
(7.1)
|
| All symptoms (Days 1-5, patient diary data) |
26.3
(14.8)
|
29.6
(14.1)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Ergoferon in Liquid Dosage Form, Placebo |
|---|---|---|
| Comments | Fever (Days 1, 3, 6 doctor's examination) | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0166 |
| Comments | p-value is not adjusted for multiple comparisons | |
| Method | Kruskal-Wallis | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Ergoferon in Liquid Dosage Form, Placebo |
|---|---|---|
| Comments | Non-specific (Days 1, 3, 6 doctor's examination) | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0820 |
| Comments | ||
| Method | Kruskal-Wallis | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Ergoferon in Liquid Dosage Form, Placebo |
|---|---|---|
| Comments | Nasal/Throat/Chest (Days 1, 3, 6 doctor's examination) | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.7227 |
| Comments | ||
| Method | Kruskal-Wallis | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Ergoferon in Liquid Dosage Form, Placebo |
|---|---|---|
| Comments | All symptoms (Days 1, 3, 6 doctor's examination) | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2645 |
| Comments | ||
| Method | Kruskal-Wallis | |
| Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Ergoferon in Liquid Dosage Form, Placebo |
|---|---|---|
| Comments | Fever (Days 1-5, patient diary data) | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0142 |
| Comments | p-value is not adjusted for multiple comparisons | |
| Method | Kruskal-Wallis | |
| Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Ergoferon in Liquid Dosage Form, Placebo |
|---|---|---|
| Comments | Non-specific (Days 1-5, patient diary data) | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0145 |
| Comments | p-value is not adjusted for multiple comparisons | |
| Method | Kruskal-Wallis | |
| Comments | ||
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Ergoferon in Liquid Dosage Form, Placebo |
|---|---|---|
| Comments | Nasal/Throat/Chest (Days 1-5, patient diary data) | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2963 |
| Comments | ||
| Method | Kruskal-Wallis | |
| Comments | ||
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Ergoferon in Liquid Dosage Form, Placebo |
|---|---|---|
| Comments | All symptoms (Days 1-5, patient diary data) | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0364 |
| Comments | p-value is not adjusted for multiple comparisons | |
| Method | Kruskal-Wallis | |
| Comments | ||
| Title | Number of Intakes of Antipyretics if Indicated |
|---|---|
| Description | Based on data mentioned in a patient's diary |
| Time Frame | On day 1, 2, 3, 4 and 5 of the treatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| Per Protocol set. |
| Arm/Group Title | Ergoferon in Liquid Dosage Form | Placebo |
|---|---|---|
| Arm/Group Description | Children aged 3 to 18 years were on the treatment regimen with Ergoferon in Liquid Dosage Form for 5 days. 1 dosing spoon (5 ml) per 1 intake: on day 1 of the treatment 8 dosing spoons (1 dosing spoon every 30 minutes for the first 2 hours, then 1 dosing spoon 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 dosing spoon tablet 3 times a day. | Children aged 3 to 18 years were on the treatment regimen with Placebo for 5 days. 1 dosing spoon (5 ml) per 1 intake: on day 1 of the treatment 8 dosing spoons (1 dosing spoon every 30 minutes for the first 2 hours, then 1 dosing spoon 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 dosing spoon tablet 3 times a day. |
| Measure Participants | 145 | 148 |
| Day 1 |
0.84
(0.86)
|
0.85
(0.78)
|
| Day 2 |
0.20
(0.57)
|
0.30
(0.71)
|
| Day 3 |
0.08
(0.36)
|
0.09
(0.40)
|
| Day 4 |
0.03
(0.26)
|
0.03
(0.25)
|
| Day 5 |
0.01
(0.17)
|
0.00
(0.00)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Ergoferon in Liquid Dosage Form, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.40 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Title | Percentage of Patients With Exacerbation of the Disease Course |
|---|---|
| Description | The development of disease complications requiring antibiotics administration or hospitalization |
| Time Frame | On days 1-6 of observation |
Outcome Measure Data
| Analysis Population Description |
|---|
| Per Protocol set. |
| Arm/Group Title | Ergoferon in Liquid Dosage Form | Placebo |
|---|---|---|
| Arm/Group Description | Children aged 3 to 18 years were on the treatment regimen with Ergoferon in Liquid Dosage Form for 5 days. 1 dosing spoon (5 ml) per 1 intake: on day 1 of the treatment 8 dosing spoons (1 dosing spoon every 30 minutes for the first 2 hours, then 1 dosing spoon 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 dosing spoon tablet 3 times a day. | Children aged 3 to 18 years were on the treatment regimen with Placebo for 5 days. 1 dosing spoon (5 ml) per 1 intake: on day 1 of the treatment 8 dosing spoons (1 dosing spoon every 30 minutes for the first 2 hours, then 1 dosing spoon 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 dosing spoon tablet 3 times a day. |
| Measure Participants | 145 | 148 |
| Number [percentage of participants] |
0
0%
|
0
0%
|
Adverse Events
| Time Frame | Adverse/Serious adverse events were registered from Day 1 to Day 6 | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=306, Safety Population) | |||
| Arm/Group Title | Ergoferon in Liquid Dosage Form | Placebo | ||
| Arm/Group Description | Children aged 3 to 18 years were on the treatment regimen with Ergoferon in Liquid Dosage Form for 5 days. 1 dosing spoon (5 ml) per 1 intake: on day 1 of the treatment 8 dosing spoons (1 dosing spoon every 30 minutes for the first 2 hours, then 1 dosing spoon 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 dosing spoon tablet 3 times a day. | Children aged 3 to 18 years were on the treatment regimen with Placebo for 5 days. 1 dosing spoon (5 ml) per 1 intake: on day 1 of the treatment 8 dosing spoons (1 dosing spoon every 30 minutes for the first 2 hours, then 1 dosing spoon 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 dosing spoon tablet 3 times a day. | ||
All Cause Mortality |
||||
| Ergoferon in Liquid Dosage Form | Placebo | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Ergoferon in Liquid Dosage Form | Placebo | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/154 (0%) | 0/152 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Ergoferon in Liquid Dosage Form | Placebo | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 3/154 (1.9%) | 2/152 (1.3%) | ||
| Ear and labyrinth disorders | ||||
| Ear ache | 1/154 (0.6%) | 0/152 (0%) | ||
| Gastrointestinal disorders | ||||
| Diarrhea | 0/154 (0%) | 1/152 (0.7%) | ||
| Vomiting | 1/154 (0.6%) | 0/152 (0%) | ||
| Nervous system disorders | ||||
| Dizziness | 1/154 (0.6%) | 0/152 (0%) | ||
| Psychiatric disorders | ||||
| Disturbance of a night's sleep | 0/154 (0%) | 1/152 (0.7%) | ||
| Skin and subcutaneous tissue disorders | ||||
| Skin rash | 1/154 (0.6%) | 0/152 (0%) | ||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Results Point of Contact
| Name/Title | Mikhail Putilovskiy, MD, PhD, Head of department of clinical trials |
|---|---|
| Organization | Materia Medica Holding |
| Phone | +74952761575 ext 302 |
| PutilovskiyMA@materiamedica.ru |
Responsible Party:
Materia Medica Holding
ClinicalTrials.gov Identifier:
NCT01843842
Other Study ID Numbers:
- MMH-ER-007
First Posted:
May 1, 2013
Last Update Posted:
Nov 29, 2018
Last Verified:
Nov 1, 2018