This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Clinical Trial of Safety and Clinical Efficacy of Ergoferon in Liquid Dosage Form in Treatment of Acute Upper Respiratory Tract Infections in Children (NCT01843842), a randomized phase 3 study. The primary outcome is Percentage of Patients With Recovery/Improvement in Health on Days 2, 3 and 4 of Observation (Based on Patient Diary Data).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01843842 |
| Phase | Phase 3 |
| Condition | Acute Upper Respiratory Tract Infections |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Quadruple |
| Enrollment | 306 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Materia Medica Holding |
| Results posted | Yes |
2. Clinical Question
Population
Children with acute upper respiratory tract infections. The registry record lists enrollment of 306 and identifies the primary-outcome population as the Per Protocol set. It does not report the eligibility criteria, age range, clinical setting, or the number of participants included in that analysis.
Intervention
Liquid Ergoferon, listed as 5 ml 3 times a day. The registry record describes the trial as assessing safety and clinical efficacy for treatment of acute upper respiratory tract infections in children. Treatment duration and further administration details are not reported in the registry record.
Comparator
Placebo, also listed as 5 ml 3 times a day. The trial is described as placebo-controlled, randomized, parallel-group, and quadruple-masked. The registry record does not specify which people or roles were masked, or how the random sequence and treatment allocation were handled.
Primary question
The primary outcome concerns the percentage of participants with recovery or improvement in health on days 2, 3 and 4 of observation, based on patient diary data. The registry record does not report the outcome values, a comparison between groups, or uncertainty estimates, so the size and precision of any difference cannot be assessed from this record.
3. Trial Design
The registry identifies NCT01843842 as a completed Phase 3 clinical trial sponsored by Materia Medica Holding. It describes a multicentre, randomized, double-blind, placebo-controlled, parallel-group trial and lists quadruple masking. Enrollment is recorded as 306. The record gives a start date of 2013-04 and a primary completion date of 2015-03.
The two interventions are liquid Ergoferon and placebo. Both arm descriptions list a dose of 5 ml 3 times a day. The registry identifies acute upper respiratory tract infections as the condition under study. It does not report the treatment period, follow-up schedule beyond the specified outcome observation days, the number or locations of participating centres, or the age range and other eligibility criteria.
Randomization and masking can help limit systematic differences in treatment assignment and outcome assessment. Those are general design principles; the registry does not detail the sequence-generation procedure, allocation concealment, or who was masked. The parallel-group structure means the arms are described as separate groups, but the record does not provide further design procedures.
The primary outcome is the percentage of participants with recovery or improvement in health on days 2, 3 and 4, based on patient diary data. The listed analysis population is the Per Protocol set. Several additional outcomes concern fever, symptom scores, symptom duration, antipyretic use, and exacerbation. The registry record does not report the numerical primary-outcome results or explain how the reported outcome time points were combined or compared.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Overall Study
| Stage | Ergoferon in Liquid Dosage Form | Placebo |
|---|---|---|
| STARTED | 154 | 152 |
| COMPLETED | 153 | 151 |
| NOT COMPLETED | 1 | 1 |
Reasons for not completing this period:
| Reason | Ergoferon in Liquid Dosage Form | Placebo |
|---|---|---|
| Do not meet inclusion criteria | 1 | 1 |
Analysis population for the primary outcome, as defined in the registry: Per Protocol set
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
| Characteristic | Unit | Ergoferon in Liquid Dosage Form | Placebo | Total |
|---|---|---|---|---|
| Participants analysed | 154 | 152 | 306 | |
| Age, Continuous | years | 9.8 (SD 4.1) | 10.2 (SD 4.2) | 10.0 (SD 4.1) |
| Sex: Female, Male: Female | Participants | 67 | 80 | 147 |
| Sex: Female, Male: Male | Participants | 87 | 72 | 159 |
| Region of Enrollment: Russia | Participants | 154 | 152 | 306 |
6. Primary Endpoint
The registry lists the primary outcome as Percentage of Patients With Recovery/Improvement in Health on Days 2, 3 and 4 of Observation (Based on Patient Diary Data), measured over On day 2, 3 and 4 of observation.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | percentage of participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is the percentage of participants recorded as having recovery or improvement in health on days 2, 3 and 4 of observation. The registry says that this assessment is based on patient diary data and identifies the analysis population as the Per Protocol set. The endpoint is therefore a binary participant-level classification, expressed as a percentage, at specified observation times. The registry record does not define the exact criteria for recovery or improvement, explain how diary entries were converted into that classification, or state how missing diary information was handled.
As a general statistical concept, a percentage gives the proportion of an analysis group meeting a stated outcome definition. It can make the frequency of an outcome interpretable, but it does not by itself describe the uncertainty around the estimate or establish whether groups differ. For a treatment comparison, readers also need group-specific results, a clearly defined contrast, and an uncertainty measure such as a confidence interval. Those numerical results are not reported in the registry record.
The endpoint is assessed on multiple observation days. A separate percentage at each time point can answer a different question from a combined summary across time. The registry record does not report a single numerical comparison that resolves those possibilities. Because the endpoint definition, results, and analysis details are incomplete, the outcome label alone cannot establish the direction, magnitude, or precision of a group difference.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record describes the trial and names its primary outcome, but it does not report the outcome values for either arm. It also does not report an effect estimate comparing Ergoferon with placebo, a confidence interval, or a p-value for the primary outcome. Consequently, the direction and magnitude of any observed difference, and how precisely it was estimated, cannot be determined from the registry record.
The primary outcome covers recovery or improvement on days 2, 3 and 4. Those are multiple assessment times, not automatically a single result. A comparison at each time could yield a different estimate from a summary that combines information across times. The record does not report which comparison was used as the primary statistical contrast, how any repeated observations were handled, or whether a particular day was designated as the decisive comparison. It therefore does not support a conclusion about a primary treatment effect.
The listed primary analysis population is the Per Protocol set. This identifies the population named in the registry, but not its size or the criteria used to determine inclusion. Without those details, readers cannot assess how the analysis population relates to the randomized groups or whether exclusions could affect interpretation. The number randomized to each arm and the number contributing primary-outcome data are not reported in the registry record.
The safety fields report zero participants affected by serious adverse events in the Ergoferon arm and zero in the placebo arm. The record also lists other adverse-event counts of 3 and 2, respectively. These counts should be read as registry entries, not as evidence that the groups had equivalent safety profiles: the record does not give a comparative analysis, uncertainty estimates, event descriptions, or enough information to judge how completely adverse events were collected. Deaths are not reported in the registry record.
The absence of numerical efficacy results is the central interpretive limitation. A trial description, even one specifying randomization, masking, and a placebo comparator, is not a substitute for the outcome data. No treatment benefit, lack of benefit, or equivalence can be inferred from the available registry results. Any assessment of the primary outcome would require the group-specific results, the analysis definition, and estimates of statistical uncertainty.
9. Statistical Methods Explained
What does a percentage outcome represent? The primary endpoint is expressed as a percentage of participants with recovery or improvement in health. As a general statistical concept, this type of outcome classifies each participant according to whether a defined event occurred, then expresses the frequency of that classification within an analysis group. The definition matters: readers need to know what counted as recovery or improvement and how diary information was evaluated. Those operational details are not reported in the registry record.
A percentage is easier to interpret alongside its denominator. For this endpoint, the record names the Per Protocol set but does not report how many participants in each arm were included or how many had usable diary data. It also does not report group-specific percentages. Therefore, neither the underlying proportions nor their sampling uncertainty can be checked from the registry record. The overall enrollment figure does not identify the analysis denominators.
How should a treatment comparison be read? In a randomized comparison, an effect estimate describes the contrast between the outcome in the intervention group and the outcome in the comparator group. The estimate needs a clearly stated scale and a defined analysis population. A confidence interval is a general statistical tool that conveys the range of estimates compatible with the observed data under the method’s assumptions. A narrow interval indicates greater precision than a wide interval, while the interval’s location helps readers assess which effects remain compatible with the data. No primary-outcome effect estimate or confidence interval is reported in the registry record.
A p-value is another general statistical summary. It relates the observed data to a specified null hypothesis under a statistical model; it is not the probability that the treatment has no effect, and it does not describe the size or clinical relevance of an estimate. The registry record does not report a primary-outcome p-value or the statistical model used. No conclusion based on statistical significance can be drawn from the endpoint description alone.
Why do multiple assessment times matter? Recovery or improvement is assessed on days 2, 3 and 4. When an outcome is evaluated repeatedly, the analysis must define whether each day is a separate comparison, whether changes over time are modeled, or whether a summary across days is used. These approaches answer different questions. Repeated measurements from the same participant are generally related rather than independent, so a method that accounts for that relationship may be relevant. This is a general methodological point, not a description of the trial’s analysis. The registry record does not report the method used or identify a single primary contrast among the listed time points.
What is multiplicity? Multiplicity arises when a study evaluates several outcomes, time points, or statistical comparisons. As a general concept, conducting many tests can increase the chance of finding a result that appears notable even when the underlying effects are absent. Possible approaches include defining a primary contrast in advance or applying an adjustment, but the appropriate approach depends on the design and research question. The registry lists a primary outcome with multiple time points and several secondary outcomes. It does not report whether multiplicity was addressed, or how the primary time points and secondary outcomes were prioritized.
What does the analysis population imply? The registry names the Per Protocol set for the primary outcome. In general, a per-protocol analysis focuses on participants who meet specified criteria for adherence and eligibility, though the exact rules vary by study. The record does not define those criteria or provide the analysis population size. Randomized trials can also report an analysis based on participants as randomized, but this registry record does not say whether such an analysis was conducted or provide its results. No comparison between analysis populations can therefore be made.
How should missing observations be considered? Diary-based outcomes can be unavailable when a participant does not complete an entry or when information cannot be classified. General statistical methods may handle missingness in different ways, and their assumptions can affect estimates. The registry record does not report the amount or pattern of missing primary-outcome data, any imputation method, or a sensitivity analysis. Readers cannot determine whether missing diary data changed the analysis set or how the analysis accounted for it.
The record includes a planning illustration described as based on the observed effect, with a two-sided significance level of 0.05, equal allocation, and a normal approximation. It describes the illustration as planning rather than the trial’s own design. The actual sample-size results from that illustration are not reported in the registry record. More generally, sample-size planning uses assumptions about the effect and variability or event frequency to estimate the information a future study might need. It does not show that an effect was observed, and it is not observed power. The registry does not report the trial’s original sample-size justification or statistical analysis plan.
10. Multiplicity, Missing Data and Analysis Populations
The primary outcome is assessed on days 2, 3 and 4, and the registry also lists secondary outcomes covering fever, body temperature, symptom scores, symptom duration, antipyretic use, and exacerbation. Multiple outcomes and assessment times create a multiplicity question: readers need to know which comparison was designated as primary and whether any adjustment or hierarchy was used to interpret the collection of analyses. The registry record does not report a multiplicity procedure or explain how results across the primary time points were combined.
The record does not report the primary-outcome results, group-specific denominators, confidence intervals, or p-values. It also does not report the amount or pattern of missing diary data, how missing values were handled, or any sensitivity analysis. For a diary-based endpoint, those details matter because unavailable entries may affect both the analysis population and the estimated percentage. No assumptions about missing data can be attributed to the trial based on this record.
The stated primary analysis population is the Per Protocol set, but the criteria defining that set and its size are not reported in the registry record. The record also does not report whether an analysis based on all randomized participants was conducted, or how its findings compared with the Per Protocol analysis. The randomization method and allocation concealment procedures are not described.
These omissions limit assessment of the robustness and precision of the outcome analysis. They do not establish that the study failed to use a particular method; they mean that the method is not reported in the registry record. The record does not include the protocol or a detailed statistical analysis plan.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Ergoferon in Liquid Dosage Form | 0 | 154 | 0.0% |
| Placebo | 0 | 152 | 0.0% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Ergoferon in Liquid Dosage Form | 3 of 154 |
| Placebo | 2 of 152 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Ergoferon in Liquid Dosage Form | Placebo |
|---|---|---|---|
| Ear ache | Ear and labyrinth disorders | 1 of 154 | 0 of 152 |
| Diarrhea | Gastrointestinal disorders | 0 of 154 | 1 of 152 |
| Vomiting | Gastrointestinal disorders | 1 of 154 | 0 of 152 |
| Dizziness | Nervous system disorders | 1 of 154 | 0 of 152 |
| Disturbance of a night's sleep | Psychiatric disorders | 0 of 154 | 1 of 152 |
| Skin rash | Skin and subcutaneous tissue disorders | 1 of 154 | 0 of 152 |
The registry safety fields list 154 participants at risk for serious adverse events in the Ergoferon arm and 152 in the placebo arm. The number affected by serious adverse events is recorded as 0 in each arm. For other adverse events, the record lists 154 participants at risk and 3 affected in the Ergoferon arm, and 152 at risk and 2 affected in the placebo arm. These are counts recorded by the registry, not a complete description of the events.
As a general statistical concept, a count of affected participants describes how many people met the recorded event classification; it does not, by itself, summarize event severity, timing, recurrence, or the uncertainty around a between-group difference. The registry does not report descriptions of the other adverse events, a comparative statistical analysis, or an explanation of the event-collection and classification procedures. The serious-event counts should therefore be read as reported counts, not as proof that the arms have the same safety profile.
Deaths are not reported in the registry record. This should not be interpreted as a reported count of zero deaths. A complete safety assessment would require further information about event definitions, collection, follow-up, and the clinical details of reported events; those details are not reported in the registry record.
12. What the Result Does, and Does Not, Mean
The registry record establishes that NCT01843842 was a completed, randomized, placebo-controlled Phase 3 trial of liquid Ergoferon in children with acute upper respiratory tract infections. It identifies recovery or improvement on days 2, 3 and 4, based on patient diary data, as the primary outcome and names the Per Protocol set as the analysis population. These details describe the trial question and intended outcome, but they do not reveal the observed primary result.
The primary-outcome percentages, group comparison, confidence interval, and p-value are not reported in the registry record. Readers therefore cannot determine whether the recorded outcomes favored either group, how large a difference may have been, or how precisely it was estimated. The endpoint description alone does not establish benefit, lack of benefit, or equivalence. A lack of reported results is not evidence that the groups had the same outcome.
The safety record lists zero participants affected by serious adverse events in each arm and lists other adverse-event counts of 3 for Ergoferon and 2 for placebo. These entries do not support a broad comparative safety conclusion because the registry does not provide event descriptions, uncertainty estimates, or further details about collection and follow-up. Deaths are not reported in the registry record.
General statistical interpretation requires more than knowing that a trial was randomized and masked. The outcome definitions, analysis population, denominators, missing-data handling, prespecified comparisons, and uncertainty estimates all affect what can be concluded. Several of these details are not reported in the registry record. The trial’s design features can be described, but they cannot replace the missing numerical results.
The registry’s planning illustration is described as a planning exercise based on an observed effect, not as the trial’s own design or as evidence of observed power. Without the primary results and the analysis details, the record does not support an estimate of the treatment contrast or its practical importance.
13. Why This Trial Matters Statistically
This trial illustrates why a registry entry needs to be read in two layers: the design description and the outcome evidence. The design information identifies a randomized, quadruple-masked, placebo-controlled, parallel-group Phase 3 study of liquid Ergoferon for acute upper respiratory tract infections in children. The primary outcome is also identifiable: a diary-based percentage of participants with recovery or improvement on days 2, 3 and 4. Those details help readers understand the research question and the planned measurement.
Statistical interpretation depends on the numerical results and how they were analyzed. Without group-specific percentages, a defined comparison, and uncertainty estimates, it is not possible to judge the direction, size, or precision of an outcome difference. Naming an endpoint is not equivalent to reporting its result. This distinction is especially relevant when an outcome is assessed at multiple times, since the statistical question depends on how those assessments are treated.
The registry also names the Per Protocol set, but does not define it or report its size. That limits transparency about who contributed to the primary analysis. Likewise, the record lists several secondary outcomes but does not describe multiplicity handling. These are not merely technical details: they help readers understand what the analysis represents and how much confidence to place in an apparent pattern.
The safety entries demonstrate a related point. Counts can be informative, but without event descriptions, comparative estimates, and collection details they cannot carry the full weight of a safety assessment. Overall, the record is useful for identifying the trial’s design, intervention, comparator, and outcome question. It is not sufficient to determine the trial’s primary efficacy findings or the precision of its safety comparisons.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The registry record does not report numerical results for the primary outcome. It gives no group-specific percentages, effect estimate, confidence interval, or p-value. This prevents assessment of the direction, size, and precision of any difference between the Ergoferon and placebo groups.
The endpoint is assessed on days 2, 3 and 4, but the record does not report how those time points were handled statistically or identify the primary contrast used for inference. It does not define the criteria for recovery or improvement, or describe how patient diary entries were converted into the endpoint classification.
The listed analysis population is the Per Protocol set, but its eligibility criteria and size are not reported. Arm-specific denominators for the primary endpoint, the amount and pattern of missing diary data, and missing-data handling are also not reported in the registry record. These gaps prevent assessment of how the analysis population was formed and whether unavailable observations affected the results.
Although several secondary outcomes are listed, the record does not describe a multiplicity strategy or provide their results. Details of random-sequence generation, allocation concealment, who was masked, and the statistical analysis plan are not reported. Eligibility criteria, age range, treatment duration, and further follow-up details are also absent from the record.
The safety information is limited to counts of participants affected by serious and other adverse events. Event descriptions, collection procedures, comparative analyses, and uncertainty estimates are not reported. Deaths are not reported in the registry record. These limits mean the safety counts cannot provide a complete account of comparative safety.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Clinical Trial of Safety and Clinical Efficacy of Ergoferon in Liquid Dosage Form in Treatment of Acute Upper Respiratory Tract Infections in Children — NCT01843842.
- Registry record last updated 2018-11-29; status last verified 2018-11.
- Results first posted 2018-08-03.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
NCT01843842 is listed as a completed Phase 3, multicentre, randomized, quadruple-masked, placebo-controlled, parallel-group trial sponsored by Materia Medica Holding. Enrollment is recorded as 306; the registry gives a start date of 2013-04 and a primary completion date of 2015-03. The study concerns liquid Ergoferon for acute upper respiratory tract infections in children, compared with placebo. Both arm descriptions list 5 ml 3 times a day.
The primary outcome is the percentage of participants with recovery or improvement in health on days 2, 3 and 4, based on patient diary data, with the Per Protocol set named as the analysis population. The registry also lists outcomes involving fever, temperature, symptom scores and duration, antipyretic use, and exacerbation.
Primary-outcome results and statistical uncertainty estimates are not reported in the registry record. Serious adverse-event counts are recorded as 0 in both arms; other adverse-event counts are 3 for Ergoferon and 2 for placebo. Deaths are not reported in the registry record.