Study to Evaluate the Efficacy and Safety of Hyoscine Butylbromide Tablets for the Treatment of Occasional or Recurrent Episodes of Gastric or Intestinal Spasm-like Pain or Discomfort: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Study to Evaluate the Efficacy and Safety of Hyoscine Butylbromide Tablets for the Treatment of Occasional or Recurrent Episodes of Gastric or Intestinal Spasm-like Pain or Discomfort (NCT02242305), a randomized phase 3 study. The primary outcome is Change of the Mean Pain Intensity Score Measured on a Visual Analogue Scale (VAS) Within 3 Days (and Within 1 Day) - ANCOVA.

2. Clinical Question

The study concerns symptom ratings recorded by participants rather than an objective measure of pain. Each participant recorded pain intensity in an evening diary, describing pain during the previous 24 hours. Baseline was the intensity of the first episode on Day 1 after randomization and before study medication. The trial therefore frames its main question around change from an individually recorded starting point, rather than a comparison of pain scores at a single follow-up assessment.

The registry describes randomization, double masking, a double-dummy design, parallel groups, and multiple centers. These design features define the intended comparison, but the record does not provide the primary outcome estimates, their uncertainty, or a test of the treatment contrast. The clinical question can be identified; its answer cannot be determined from the results reported in the registry record.

3. Trial Design

This is a randomized, double-blind, double-dummy, active-controlled, parallel-group, multi-center Phase 3 trial. The registry lists enrollment as 302 and status as completed. The recorded start date is 2008-11-01, and the primary completion date is 2009-07-20. Boehringer Ingelheim is listed as the sponsor.

The official title describes a comparison of hyoscine butylbromide tablets with hyoscine butylbromide Capsule 10mg. It identifies the tablets as 10 mg and states a regimen of 20mg, 3 Times Daily, Orally, over a period of 3 days. The brief summary likewise frames the study as a comparison with capsules. The arm descriptions themselves are blank, so additional details about the treatment regimens are not reported in the registry record.

Double-dummy designs are generally used when treatments differ in how they are given or appear: participants can receive matching active and inactive treatments to help maintain masking. That is a general description of the design concept, not confirmation of the specific dosing or administration procedures used in this trial. The registry identifies placebo as an intervention, but does not explain its role in the arm structure. The two safety groups listed are the tablet and capsule groups.

The trial’s primary measure is change in mean pain intensity on a Visual Analogue Scale, described for the treatment period and for an earlier assessment within 1 day. The registry names ANCOVA as the analysis method in the primary outcome title. It also lists secondary measures covering pain frequency, patient global assessment of efficacy, adverse events, investigator assessment of tolerability, clinically relevant abnormalities across laboratory and other examinations, and time to therapeutic effect.

The record does not report the detailed randomization procedure, allocation ratio, masking procedures, site count, or protocol deviations by group. It also does not report a full statistical analysis plan. Those details should not be inferred from the broad design labels.

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: Per-Protocol Set (PPS): All randomized subjects in FAS without any major protocol violation were included into the per protocol set, including those subjects who had good treatment compliance (80% to 120%), who did not take any restriction medications during the study period and whose Case Report Form (CRF) was complete as requested.

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: Full Analysis Set (FAS): According to the Intent-to-Treat (ITT) principle, all randomized subjects who took at least one dose of study medication and who provided any data for the primary efficacy endpoint were used in FAS. Baseline participants less than participant flow as no abdominal pain within 3 weeks following randomization were withdrawn.

6. Primary Endpoint

The registry lists the primary outcome as Change of the Mean Pain Intensity Score Measured on a Visual Analogue Scale (VAS) Within 3 Days (and Within 1 Day) - ANCOVA, measured over 3 days (1 day).

The primary endpoint is change from baseline in mean pain intensity, measured using a Visual Analogue Scale, during the treatment period. The registry describes assessments within 3 days and within 1 day. Participants recorded pain intensity in an evening diary for the previous 24 hours. Baseline was the pain intensity of the first episode on Day 1 after randomization and before study medication. The scale runs from 0 to 10 cm, anchored by no pain and the most severe pain imaginable.

A change-from-baseline measure is used to describe how an outcome moves relative to each participant’s starting measurement. In general, this can account for differences in starting scores when treatment groups are compared. A pain-intensity scale also captures the participant’s own experience, which is pertinent when the symptom of interest is pain. The diary format records the participant’s rating in relation to a defined period, rather than relying only on recall at a later visit.

The registry names ANCOVA for this endpoint. In general, analysis of covariance compares outcomes between groups while accounting for specified covariates; the covariates used in this trial are not reported in the registry record. The outcome description identifies the Per-Protocol Set as the analysis population, but the posted definition is truncated. The estimated change in either period, the contrast between groups, and its uncertainty are not reported in the registry record. Thus, the endpoint and its intended measurement can be described, but the magnitude and precision of the observed comparison cannot be assessed.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does ANCOVA mean?

ANCOVA, or analysis of covariance, is a general statistical approach for comparing an outcome across groups while adjusting for selected covariates. For a change-from-baseline endpoint, the analysis may account for starting measurements or other prespecified characteristics, depending on the model. This can help make the comparison more precise when the included covariates are informative and the model is appropriate. These are general properties of ANCOVA, not details confirmed about the model used in this trial.

The primary outcome title names ANCOVA, but the registry record does not report the covariates, model specification, handling of treatment-by-covariate terms, assumptions checks, or the estimate produced by the model. It also does not report whether the within-1-day and within-3-day assessments used the same model specification. Without those details, the method can be identified at a broad level, but it cannot be independently reconstructed or fully evaluated.

What does a change-from-baseline endpoint express?

A change score describes movement from a participant’s baseline value to a later measurement or defined period. In general, this puts the focus on improvement or worsening relative to the starting point rather than on the later score alone. The trial defines the baseline pain intensity as the first episode on Day 1 after randomization and before study medication. It describes the mean VAS score over the 3-day treatment period and names change within 3 days and within 1 day as the endpoint timeframes.

Because the scale is completed by participants, the measurement represents their recorded perception of pain. The registry says ratings were made in an evening diary for pain during the previous 24 hours. Diary-based measurement can structure reporting over time, but it does not eliminate measurement error or differences in how individuals use a scale. These are general considerations; the record does not report measurement reliability or the frequency of missing diary entries.

How should a treatment estimate and confidence interval be read?

In general, a treatment estimate describes the direction and magnitude of a comparison on the outcome’s scale. A confidence interval expresses statistical uncertainty around that estimate under the model and its assumptions. A narrower interval represents greater precision than a wider interval, while an interval that includes values on both sides of no difference may be compatible with different interpretations. These general explanations do not describe the result of this trial: the primary estimate and its confidence interval are not reported in the registry record.

A p-value, when reported, addresses how compatible the observed data are with a specified null model; it does not measure clinical importance or the probability that a treatment effect is true. The registry record does not report a primary p-value. Without the estimate and its uncertainty, readers cannot judge the precision or inferential result of the primary comparison.

What does the design contribute?

Random assignment is generally intended to balance prognostic factors across treatment groups on average, reducing the risk that treatment comparisons are driven by systematic differences at entry. Double masking is generally intended to limit differences in participant and investigator expectations or assessment. A double-dummy design is generally a way to preserve masking when treatments have different presentations. These are general aims of the named design features; the registry does not describe how assignment was generated, how masking was maintained, or whether masking was assessed.

Parallel-group designs compare groups assigned to different strategies over the study period. The record describes this trial as parallel-group and active-controlled. An active control means the comparison is framed against another active treatment rather than solely against no active treatment. The registry’s official title identifies capsules as the comparator. Although placebo appears in the intervention list, its role in the comparison is not reported in the registry record.

How do the planning assumptions differ from trial results?

In general, a sample-size calculation is a planning exercise based on assumptions about the effect to detect, variability, significance level, allocation, and statistical method. The assumptions listed for the planning illustration specify a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. The illustration is described as using a fraction of the observed effect. These assumptions are not the trial’s own design justification, and the illustration is not observed power.

Planning estimates are not outcome findings. They do not show how many participants were needed under the trial’s actual protocol, nor do they establish whether the study had adequate power for its observed results. The trial’s own sample-size justification, the effect assumptions used in its protocol, and any interim analyses are not reported in the registry record. The planning illustration should therefore be understood as a conditional calculation, not as evidence about the treatment comparison.

What can be concluded from the analysis information?

The record allows identification of the primary measurement, its timeframes, the stated analysis family, and the named analysis population. It does not provide the model output needed to interpret the primary comparison. It also does not give enough detail to reproduce the analysis or assess its assumptions. Any explanation of ANCOVA, confidence intervals, randomization, masking, or planning calculations is general statistical context, not a substitute for the results and methods absent from the registry record.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists the primary endpoint at more than one timeframe: change within 3 days and within 1 day. It also lists secondary outcomes across pain frequency, patient and investigator assessments, adverse events, clinical abnormalities, and time to therapeutic effect. When several endpoints or timepoints are evaluated, multiplicity can arise because repeated tests increase the chance of at least one apparently unusual result under a global null. In general, analysis plans may address this through prespecified outcome hierarchies or adjustment procedures. The approach used for this trial is not reported in the registry record.

The primary outcome title indicates ANCOVA, but the record does not describe how the within-1-day and within-3-day assessments were prioritized, whether either was a key confirmatory test, or how multiple comparisons were handled. The registry also does not report the results for the secondary outcomes. Their inclusion in the outcome list does not establish that all were analyzed or that any particular multiplicity strategy was used.

The primary endpoint is described for the Per-Protocol Set. The record gives a partial definition: it refers to randomized subjects in the Full Analysis Set without major protocol violations and mentions treatment compliance of 80% to 120%, no restricted medications during the study period, and case-report-form criteria. The definition is truncated, and the full analysis-population descriptions are not reported in the registry record. The treatment-group counts for the primary analysis are also not reported.

The registry does not describe missing-data amounts, reasons for missing diary entries, imputation, sensitivity analyses, or how participants with incomplete follow-up were handled. These details matter because incomplete outcome data can affect the interpretation of a group comparison. Without the relevant methods and results, the robustness of the primary analysis cannot be assessed.

11. 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 5% reporting threshold.

The registry’s adverse-event entries list zero serious adverse events and zero other adverse events in the hyoscine butylbromide tablet group, with 146 at risk. The capsule group entries list zero serious adverse events and zero other adverse events, with 142 at risk. The deaths field is not reported in the registry record, and no serious adverse event terms are listed.

These figures describe the recorded counts for the groups and categories shown. They should not be read as proof that no adverse experiences of any kind occurred. The record does not provide event definitions, follow-up completeness, exposure time, severity details beyond the serious-event category, or a fuller account of how events were collected and coded. The secondary outcome list includes adverse events and tolerability measures, but corresponding results are not reported in the registry record.

In general, safety interpretation considers the number of events, the number of participants assessed, the duration of observation, and the nature and severity of events. The listed at-risk counts give group denominators for these entries, but the record does not provide the additional detail needed to characterize event timing or patterns. The zero counts are therefore a limited registry summary, not a comprehensive assessment of safety.

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

The registry record establishes that a randomized, double-blind, double-dummy, active-controlled, parallel-group trial was conducted to evaluate hyoscine butylbromide tablets in comparison with capsules for self-reported gastric or intestinal spasm-like pain. It identifies a participant-recorded pain-intensity outcome, its baseline definition, its intended timeframes, and ANCOVA as the named analysis method. It also provides selected adverse-event counts for the tablet and capsule groups.

It does not report the primary treatment estimates, confidence intervals, or p-values. That omission prevents assessment of the size and direction of the comparison, its statistical precision, and the extent to which the observed data distinguish among possible effects. The existence of a completed trial, a defined endpoint, or an analysis label cannot fill that gap.

The record also does not report results for the listed secondary outcomes. Therefore, the available information cannot establish what the study found about pain frequency, global assessments, tolerability, clinical abnormalities, or time to therapeutic effect. Nor does it provide enough information to assess missing data, multiplicity, or the full analysis populations.

In general, statistical evidence is interpreted by considering the estimate, its uncertainty, the design, and the analysis choices together. Even a precise estimate would not by itself settle questions about clinical importance or applicability beyond the study population. Here, the primary estimate and its uncertainty are absent, so those further judgments cannot be made from the registry record. The safety counts should likewise be kept within their narrow scope: they report zero events in the listed categories, while other safety details and the deaths field are not reported in the registry record.

The most defensible reading is that the registry describes how the comparison was intended to be conducted and measured, but does not provide the primary results needed to interpret its outcome.

13. Why This Trial Matters Statistically

This trial is statistically informative as an example of the difference between a clearly defined research question and a result that can be evaluated. The record specifies randomization, masking, the active comparator, the pain-intensity scale, and the primary analysis label. Those details help identify the intended estimand: change in a participant-rated pain measure over a defined treatment period, compared between tablet and capsule groups.

The trial also illustrates why endpoint definitions matter. Baseline is tied to the first episode on Day 1 after randomization and before medication, and ratings concern pain during the previous 24 hours. This makes the timing and reference point part of the meaning of the outcome, rather than incidental data-collection details. The record describes assessments within 1 day and within 3 days, so interpretation would also depend on how the timeframes were handled in the analysis.

At the same time, the record shows the limits of design information without outcome estimates. Knowing that ANCOVA was named does not reveal the adjusted comparison, its uncertainty, or the assumptions used. Knowing that the study was randomized and double-blind does not replace the need for results. Likewise, a planning illustration based on the observed effect is not a measure of observed power and cannot be treated as the trial’s own sample-size justification.

The safety entries provide another useful statistical distinction: zero recorded events in specified categories is not the same as proof of no risk. Counts need context about definitions, observation, and data completeness. The record’s limited safety information therefore supports only a narrow description of the listed counts.

Overall, the study raises a clinically focused comparison but the registry information available for interpretation is incomplete. The design and endpoint can be described, while the treatment effect and its precision remain undetermined from the registry record.

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 main limitation for interpreting this trial is that the registry record does not report the primary outcome results. The treatment-group changes, comparison estimate, uncertainty interval, and test result are absent. The record therefore does not permit a statistical assessment of the primary question, even though it describes the endpoint and names ANCOVA.

The primary outcome population is described as the Per-Protocol Set, but its definition is truncated. The full criteria, number analyzed in each group, and reasons for any exclusions are not reported in the registry record. A per-protocol analysis can differ from an analysis that retains all randomized participants, so the missing analysis-population details limit understanding of how the result was intended to represent the randomized comparison.

The registry does not report missing diary data, data-handling methods, model covariates, model diagnostics, or sensitivity analyses. It also does not state how multiplicity was addressed across the two timeframes and the listed secondary outcomes. These omissions limit assessment of the analysis’s robustness and its inferential interpretation.

The official title gives tablet strength and regimen wording, while the arm descriptions are blank. Placebo is listed as an intervention, but its role is not explained. The record does not report the randomization sequence, allocation concealment, masking procedures, site count, or protocol deviations by group. These details should not be inferred from the design labels.

Finally, the safety record is limited to selected counts. It does not report the deaths field, event timing, exposure-adjusted summaries, or detailed event descriptions. These are limitations of the registry information available for this analysis, not assertions that the information was absent from the full trial documentation.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Study to Evaluate the Efficacy and Safety of Hyoscine Butylbromide Tablets for the Treatment of Occasional or Recurrent Episodes of Gastric or Intestinal Spasm-like Pain or Discomfort — NCT02242305.
• Registry record last updated 2017-07-27; status last verified 2017-07.
• Results first posted 2017-07-27.
• 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.

18. Record Summary

NCT02242305 is a completed Phase 3 randomized, double-blind, double-dummy, active-controlled, parallel-group, multi-center trial sponsored by Boehringer Ingelheim. It enrolled 302 participants and compared hyoscine butylbromide tablets with capsules for self-reported gastric or intestinal spasm-like pain or discomfort. The recorded start date is 2008-11-01 and the primary completion date is 2009-07-20.

The primary endpoint is change in mean pain intensity on a Visual Analogue Scale, described within 3 days and within 1 day, with ANCOVA named in the outcome title. The outcome description identifies the Per-Protocol Set, but its definition is truncated. Primary treatment estimates and uncertainty are not reported in the registry record. The safety entries list zero serious and zero other adverse events for the tablet and capsule groups; deaths are not reported in the registry record.