IndoProCaf Effervescent Tablets Effectiveness in Acute Treatment of Migraine and/or Episodic Tension-type Headache and Patients' Satisfaction With the Treatment in Routine Clinical Practice: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for IndoProCaf Effervescent Tablets Effectiveness in Acute Treatment of Migraine and/or Episodic Tension-type Headache and Patients' Satisfaction With the Treatment in Routine Clinical Practice (NCT02115269), a registered phase not stated study. The primary outcome is Percentage of Patients With Significant Pain Reduction.

2. Clinical Question

3. Trial Design

This was a completed post-marketing observational study of IndoProCaf effervescent tablets for acute treatment of primary headache attacks in routine clinical practice. The record identifies Ukraine and Kazakhstan as the settings. The enrolled population was adults taking the treatment for migraine and/or episodic tension-type headache attacks as part of usual clinical care. Registry enrollment was 759; that figure is not necessarily the number included in the primary endpoint analysis.

The record describes a treatment arm for patients taking IndoProCaf and does not describe a randomized control comparison. Allocation is not stated, and the registry explicitly notes that the arms are not a like-for-like control comparison. Consequently, the design should be read as observational rather than as a randomized efficacy trial. Treatment was used in routine practice; the record does not report a standardized treatment assignment procedure, a placebo group, or a concurrent comparator suitable for a controlled contrast.

The study start is recorded as 2014-06 and primary completion as 2015-11. Its status is COMPLETED. These administrative dates do not, by themselves, establish the timing of individual follow-up or the duration of observation for each participant. Those details are not reported in the registry record.

The primary outcome was the percentage of patients with significant pain reduction, assessed up to 2 hours after dosing. The registry also lists secondary outcomes concerning time to significant pain reduction, pain reduction after no response to the first dose, pain reduction after headache relapse, and satisfaction with medicines previously used for headache attacks. Six outcome measures are listed, but the registry record reports no outcome analyses. It does not provide the primary endpoint estimate, secondary endpoint results, confidence intervals, or p-values.

The record identifies Abbott as the sponsor. It does not report enough detail to reconstruct the full protocol, the clinical procedures used at each site, or the statistical analysis plan. Those omissions limit assessment of how closely the recorded outcomes correspond to planned procedures.

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

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Number of patients in full analysis set. Full analysis set included all patients who signed informed consent and complied with all the inclusion and exclusion criteria and who had at least one acceptable headache attack treated with IndoProCaf documented in the patient's diary. This population was used for the effectiveness endpoints reporting.

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.

Population: Safety set included all enrolled patients who have taken at least one dose of IndoProCaf

6. Primary Endpoint

The registry lists the primary outcome as Percentage of Patients With Significant Pain Reduction, measured over up to 2 hours.

The primary endpoint is the percentage of participants with significant pain reduction up to 2 hours after dosing. The registry defines significant reduction by a change in headache severity to mild or no pain at 2 hours, assessed with a four-point pain severity scale. The scale labels are no pain, mild headache allowing normal activities, moderate headache disturbing normal activities, and severe headache disabling activities and requiring bed-rest.

This endpoint translates a change in pain severity into a participant-level response: a person either meets the stated improvement definition or does not. Reporting a percentage can make the frequency of this response easier to interpret than a group average alone. The definition also supplies a clinical threshold rather than treating every small change in a severity rating as equivalent to meaningful improvement.

The endpoint is a short-term measure following an acute dose. It does not, by itself, describe how long improvement lasted, whether headache later returned, how often treatment was used, or whether participants were satisfied with the treatment. The registry lists some of these as separate secondary outcomes, but their results are not reported in the registry record.

The endpoint definition and timeframe are reported, but the observed number of participants meeting the definition and the resulting percentage are not. Therefore, the endpoint’s measurement can be explained, but its observed value and precision cannot be assessed from the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry record gives an outcome definition and some design information, but does not report the statistical analysis plan or outcome analyses. General explanations of the relevant statistical ideas can clarify what would be needed to interpret the endpoint, without implying that those methods were used in this study.

What does a percentage endpoint represent?

For a binary response, each participant is classified according to whether the specified event occurred. The response percentage describes the share of evaluable participants meeting the event definition. Its interpretation depends on both parts of the calculation: the number meeting the definition and the number assessed. The registry’s primary endpoint has a binary definition based on pain improving to mild or no pain by 2 hours. But the observed count and percentage are not reported in the registry record, and the analysis denominator is also not reported. Enrollment alone cannot stand in for that denominator because enrollment and endpoint evaluability are different concepts.

A response percentage is more informative when accompanied by a confidence interval. General explanation: a confidence interval conveys the uncertainty around an estimate arising from sampling variability and, under the method’s assumptions, identifies a range of values compatible with the data at the stated confidence level. A narrower interval indicates greater precision; a wider interval indicates less precision. Neither the endpoint estimate nor a confidence interval is reported, so the registry does not allow readers to judge the endpoint’s precision.

Why does the outcome definition matter?

The registry defines significant pain reduction by reaching mild or no pain at 2 hours. A threshold-based outcome has a clear interpretation, but it also compresses information: participants just meeting the threshold and those with a greater improvement both count as responders, while changes that do not cross the threshold do not. The scale descriptions give clinical meaning to the categories, but the record does not report the distribution of severity ratings or the number crossing the response threshold. Nor does it report how diary entries were checked or handled when incomplete.

General explanation: measurement rules should be specified before analysis because changes to thresholds, timing windows, or handling of missing assessments can alter a binary response rate. The registry states the endpoint definition and timeframe, but does not report whether there were deviations from the stated assessment or how such deviations were treated.

What can a comparison establish?

In a randomized comparison, random assignment is intended to make groups comparable, on average, with respect to measured and unmeasured factors at the start of follow-up. In an observational study, treatment is not established by random assignment in the registry record, and the note explicitly says this is not a randomized comparison. Thus, an outcome percentage among treated participants describes what was recorded in that group; it does not by itself estimate what would have happened to the same participants under a different treatment or no treatment.

General explanation: a control group can help distinguish a treatment-associated change from changes that might occur because of the natural course of a condition, expectations, co-interventions, or measurement practices. A comparison is most interpretable when its groups are comparable and outcome ascertainment is consistent. The record does not establish a like-for-like control comparison, and it does not report adjusted analyses that might address differences among participants. It is therefore not possible to infer a causal treatment contrast from the registry information.

How should uncertainty and p-values be read?

General explanation: a p-value evaluates how compatible the observed data are with a specified null model, conditional on the assumptions of the test. It does not measure the probability that a treatment works, nor does it describe the size or practical importance of an effect. An estimate and its confidence interval are generally needed to understand magnitude and precision. The registry reports no analyses, so there are no reported p-values or intervals to interpret.

When results are recalculated from summary statistics, they are unadjusted recalculations and may differ from a sponsor’s own analysis because of rounding, analysis populations, covariate adjustment, or other methodological choices. No recalculated result is reported in this registry record. Any planning illustration based on an observed effect would not be an outcome analysis; sample-size calculations describe a hypothetical design under stated assumptions and do not show the power actually achieved in a completed study.

What does over-dispersion mean in general?

Over-dispersion describes variation greater than a statistical model assumes. For example, outcomes may be more variable because observations are clustered, participants differ substantially, or events are not independent. If a model ignores excess variation, its standard errors can be too small and its confidence intervals too narrow. This is a general statistical concern, not a reported feature of this study. The registry record does not describe a model, clustering adjustment, or assessment of over-dispersion.

For this study, the basic interpretive requirements remain the same: a reported endpoint count, analysis denominator, estimate, and uncertainty measure would be needed to assess the response rate; details of the analysis population and missing data handling would be needed to assess possible bias; and a credible comparison would be needed for a causal contrast. These elements are not reported in the registry record.

10. Exact Estimates for Each Arm

No two-arm comparison is shown for this trial, but each arm's result can still be summarized with exact interval estimates computed from the posted counts. The Clopper-Pearson interval is exact and conservative; the Wilson interval is a common closer-to-nominal alternative; the Bayesian credible interval uses a uniform Beta(1, 1) prior. For small groups the three can differ noticeably.

R code and output

arm    <- c("Primary Headaches")
n      <- c(663)
events <- c(599)
for (i in seq_along(n)) {
  ci <- binom.test(events[i], n[i])$conf.int          # Clopper-Pearson exact interval
  cr <- qbeta(c(0.025, 0.975), 1 + events[i], 1 + n[i] - events[i])   # Bayesian, uniform Beta(1,1) prior
  wi <- (function(x, n) { p <- x / n; z <- qnorm(0.975); d <- 1 + z^2 / n
    c((p + z^2 / (2 * n) - z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d, (p + z^2 / (2 * n) + z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d) })(events[i], n[i])
  cat(sprintf("ARM|%s|%d|%d|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f\n", arm[i], n[i], events[i], 100 * events[i] / n[i],
              100 * ci[1], 100 * ci[2], 100 * wi[1], 100 * wi[2], 100 * cr[1], 100 * cr[2]))
}

ARM  Primary Headaches  663  599  90.3  87.8  92.5  87.9  92.4  87.9  92.4

11. Multiplicity, Missing Data and Analysis Populations

The registry lists six outcome measures, including the primary endpoint and secondary outcomes concerning time to pain reduction, response after no response to the first dose, response after headache relapse, and satisfaction with medicines previously used for headache attacks. Because multiple outcomes can be examined, readers would ordinarily want to know which was primary for confirmatory inference, whether secondary analyses were exploratory, and whether any procedure was used to account for multiple testing. The registry record does not report a multiplicity strategy or the statistical analysis plan.

Multiplicity matters because testing several hypotheses can increase the chance that at least one result appears unusual by chance when each test is considered separately. General explanation: adjustment methods can control error rates across a family of tests, while a clearly prespecified hierarchy can identify which outcomes carry confirmatory weight. These approaches affect interpretation; they do not change the clinical meaning of the endpoint itself. Since no outcome analyses or p-values are reported, the registry does not allow assessment of whether multiplicity affected any claimed findings.

The primary endpoint population is described as participants who signed informed consent, met inclusion and exclusion criteria, and had at least one acceptable treated headache attack documented in a diary. The description is truncated in the registry record, and the number included in this population is not reported. Enrollment of 759 should not be read as the primary analysis denominator.

Missing-data handling is also not reported. The record does not say how missing diary entries, unavailable 2-hour assessments, or participants without an acceptable attack were handled in the endpoint analysis. General explanation: excluding participants with missing outcomes can lead to bias if the probability of missingness is related to their response. Different assumptions or sensitivity analyses may be appropriate, but the registry does not describe any such approach. Consequently, neither the extent nor the possible influence of missing outcome data can be assessed.

12. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: hypertension crisis (0.1%), face oedema (0.1%), loss of consiousness (0.1%).

For the primary-headache group, the registry reports 702 participants at risk and 3 affected for serious adverse events. For other adverse events, it reports 702 at risk and 16 affected. The registry lists Hypertension crisis, Face oedema, and Loss of consiousness as serious adverse event terms, each with a reported value of 0.1%. The spelling of the last term follows the registry record. Deaths are not reported in the registry record.

These figures describe recorded events in the registry; they are not estimates of treatment-attributable risk. Without a like-for-like control comparison, the counts do not establish whether an event was caused by IndoProCaf or whether the event frequency differs from another treatment or from no treatment. The record does not report details such as event ascertainment procedures, follow-up completeness, or how the listed percentages were calculated.

Serious adverse events and other adverse events are separate categories in the registry summary and should not be combined or treated as interchangeable. The listed percentages do not provide a full safety profile, and the absence of a reported event is not evidence that it could not occur. The available record supports describing the reported counts and terms, but not a comparative safety conclusion.

13. What the Result Does, and Does Not, Mean

The registry record defines a specific short-term response: pain improving to mild or no pain by 2 hours after dosing. It also identifies a routine-practice setting and an adult population treating migraine and/or episodic tension-type headache attacks with IndoProCaf. These details make the intended clinical question understandable and distinguish the endpoint from longer-term outcomes such as duration of relief, recurrence, or satisfaction.

What the record does not provide is the observed result for that primary endpoint. There is no reported response count, percentage, confidence interval, or p-value. The listed enrollment of 759 is not a substitute for the number assessed at the endpoint. The registry also lists secondary measures, but reports no analyses for them. Thus, the available information does not show the magnitude or precision of any observed pain response.

Even if a treated-group response rate were reported, this observational design would not, by itself, establish that the treatment caused the response. The registry notes that this is not a randomized comparison and does not describe a like-for-like control. Outcomes in routine practice can reflect patient characteristics, condition course, expectations, concurrent care, and how outcomes are recorded, as well as treatment exposure. A controlled causal estimate would require an appropriate comparison and analysis, neither of which is reported.

The safety summary likewise reports recorded event counts and terms rather than a comparative estimate. The serious adverse event counts and listed percentages should be read as registry descriptions, not as proof of causation or as a complete accounting of risk. Deaths are not reported in the registry record.

Accordingly, the record is useful for understanding the study’s purpose, setting, endpoint definition, and selected safety entries. It does not establish an estimate of effectiveness, its precision, or a causal treatment effect. It also does not support conclusions about unreported secondary outcomes or the completeness of adverse event capture. Those limits arise from what is reported, not from the endpoint definition itself.

14. Why This Trial Matters Statistically

This study addresses a statistical question that commonly arises when a treatment is used in routine clinical practice: how to describe participant outcomes when treatment is not assigned through a randomized comparison. Observational data can provide information about use and recorded outcomes in a clinical setting, but interpretation depends on clear definitions, complete reporting, and a careful distinction between a treated-group description and a causal comparison.

The primary endpoint has a stated clinical threshold and timeframe: improvement to mild or no pain by 2 hours. A well-reported response proportion could communicate the frequency of this defined outcome. To assess its precision and interpretability, readers would also need the response count, analysis denominator, uncertainty interval, and an account of missing assessments. These are not reported in the registry record, illustrating why outcome definitions alone are not enough to evaluate a result.

The record also highlights the distinction between an endpoint being registered and an endpoint being analyzed and reported. Six outcome measures are listed, but the registry reports zero analyses. Without results, statistical methods cannot be judged against observed estimates, and multiplicity cannot be evaluated in practice. Transparent reporting of analysis populations, missing-data handling, and uncertainty is essential to make registry findings reproducible and useful.

Finally, the serious adverse event summary shows why safety counts need context. Counts can describe recorded events, but without a comparable control group and sufficient information on ascertainment and follow-up, they do not establish causal attribution or comparative risk. The statistical value of this record lies chiefly in its design and outcome definitions; its reporting gaps prevent quantitative evaluation of the primary response question.

15. 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 central limitation is that the primary endpoint result is not reported in the registry record. The number of participants meeting the definition, the analysis denominator, and the resulting percentage are absent. No confidence interval or p-value is reported, so the magnitude and precision of the endpoint cannot be assessed.

The study is described as observational and not as a randomized comparison. Allocation is not stated, and the record says the arms are not a like-for-like control comparison. It therefore does not provide a basis for isolating a causal treatment effect through a controlled contrast. Details that might clarify participant selection, treatment use, or potential confounding are not reported.

The full description of the primary analysis population is incomplete. Although the record states that participants had to consent, meet inclusion and exclusion criteria, and have at least one acceptable treated attack recorded in a diary, the population description ends prematurely. The number analyzed and the relationship between enrollment and endpoint availability are not reported.

The registry lists six outcome measures but reports no analyses. It does not provide a statistical analysis plan, multiplicity approach, missing-data method, or information about deviations from the endpoint’s stated timing and definition. These omissions make it impossible to determine how the listed outcomes were analyzed or whether missing observations could affect the results.

Safety reporting is also limited to the stated adverse event counts and terms. Follow-up completeness, ascertainment methods, and causal assessment are not reported. Deaths are not reported in the registry record; this should not be interpreted as a confirmed absence of deaths. Overall, the registry record identifies the intended question but does not contain the outcome reporting needed for a quantitative assessment.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: IndoProCaf Effervescent Tablets Effectiveness in Acute Treatment of Migraine and/or Episodic Tension-type Headache and Patients' Satisfaction With the Treatment in Routine Clinical Practice — NCT02115269.
• Registry record last updated 2017-11-06; status last verified 2017-10.
• Results first posted 2017-09-25.
• 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.

19. Record Summary

The record describes a completed post-marketing observational study of IndoProCaf effervescent tablets for acute treatment of migraine and/or episodic tension-type headache in routine clinical practice in Ukraine and Kazakhstan. Abbott is listed as sponsor. Enrollment is 759; the study start is 2014-06 and primary completion is 2015-11.

The primary endpoint is the percentage of participants with pain improved to mild or no pain by 2 hours after dosing. The record lists six outcome measures and defines an eligible primary analysis population, though that description is incomplete. It reports zero analyses, and the primary endpoint estimate and its uncertainty are not reported in the registry record. The design is not described as a randomized comparison, and allocation is not stated.

The safety summary reports 3 affected for serious adverse events and 16 affected for other adverse events, each with 702 at risk. Three serious adverse event terms are listed, each at 0.1%. Deaths are not reported in the registry record. These entries do not establish comparative or causal effects.