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 Randomized Control Trial Comparing Prokinetics and Their Influence on Endoscopy Outcomes for Upper GI Bleed. (NCT02017379), a randomized na study. The primary outcome is Erythromycin, Metoclopromide vs Control Enabling Visualization of the Entire Gastric Mucosa ..
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02017379 |
| Phase | NA |
| Condition | Upper Gastrointestinal Bleeding |
| Allocation | Randomized |
| Design model | Factorial |
| Masking | Double |
| Enrollment | 4 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Texas Tech University Health Sciences Center, El Paso |
| Results posted | Yes |
2. Clinical Question
Population
Patients with upper gastrointestinal bleeding undergoing endoscopy. The registry record does not report further eligibility details or participant characteristics.
Intervention
Intravenous erythromycin infusion, dose 250 mg, 30 min-60 min before the procedure, or intravenous metoclopromide infusion, dose 10 mg, 30-60 minutes prior to endoscopy.
Comparator
Control, described as no medications before endoscopy. The record does not report the number of participants assigned to each group.
Primary question
Whether erythromycin or metoclopramide, compared with control, enables visualization of the entire gastric mucosa at the stated 45 minutes timeframe.
The study concerns the visibility of the stomach lining during endoscopy in the setting of upper gastrointestinal bleeding. The registry summary describes the two study drugs as prokinetics and frames their proposed role as speeding stomach emptying before endoscopy. The clinical question is therefore about whether the whole gastric mucosa can be visualized, not simply whether a drug was administered or whether an endoscopy took place.
The registry lists source of bleeding, second-look endoscopy, blood units transfused, and mortality among the secondary outcomes. These outcomes could address other aspects of the clinical course, but their inclusion does not establish that any were measured or analyzed. The record says the study was terminated, the principal investigator left the institution, efforts to contact the study team were unsuccessful, and no study data are available. Consequently, the clinical question remains unanswered by the posted results. The record does not report an observed comparison of either intervention with control.
3. Trial Design
The registry describes a randomized, double-masked study with a factorial model. The condition is upper gastrointestinal bleeding, and the listed interventions are erythromycin and metoclopromide. The control arm is described as receiving no medication before endoscopy. The record does not explain the factorial structure, including how treatment factors were arranged or which comparisons were planned.
The recorded enrollment is 4. That figure describes enrollment in the registry; the record does not report how participants were distributed among the arms, whether all enrolled participants were randomized, or how many contributed data to any outcome. The study phase is listed as NA. The sponsor is Texas Tech University Health Sciences Center, El Paso.
The recorded study start is 2014-06 and primary completion is 2014-09. The status is terminated. The primary outcome timeframe is 45 minutes. The record states that the study was terminated and that the principal investigator left the institution. Efforts to contact the principal investigator or other study team members were unsuccessful, and no study data are available.
Randomization is intended, in general, to reduce systematic differences between treatment groups at assignment. Masking is intended to limit the influence of knowledge about treatment assignment on care, assessment, or reporting. Those are general purposes of these design features, not evidence that they were successfully implemented in this study. The registry record does not report the randomization procedure, allocation concealment, who was masked, or whether masking was maintained. With no participant-level or group-level outcome results, the design description cannot be used to estimate an intervention effect.
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 | Erythromycin | Metoclopromide | Control |
|---|---|---|---|
| STARTED | 0 | 0 | 0 |
| COMPLETED | 0 | 0 | 0 |
| NOT COMPLETED | 0 | 0 | 0 |
Analysis population for the primary outcome, as defined in the registry: The study was terminated and the PI has left the institution. Efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available.
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: The study was terminated and the PI has left the institution. Efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available.
| Characteristic | Unit | Erythromycin | Metoclopromide | Control | Total |
|---|---|---|---|---|---|
| Participants analysed | 0 | 0 | 0 | 0 | |
| Age, Categorical: <=18 years | — | — | — | — | |
| Age, Categorical: Between 18 and 65 years | — | — | — | — | |
| Age, Categorical: >=65 years | — | — | — | — | |
| Sex: Female, Male: Female | — | — | — | — | |
| Sex: Female, Male: Male | — | — | — | — | |
| Region of Enrollment: United States | participants | — | — | — | — |
6. Primary Endpoint
The registry lists the primary outcome as Erythromycin, Metoclopromide vs Control Enabling Visualization of the Entire Gastric Mucosa ., measured over 45 minutes.
| Element | Registry entry |
|---|---|
| Result type | N/A |
| Measure of spread | not applicable |
| Unit | not stated |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint concerns whether erythromycin or metoclopramide, compared with control, enables visualization of the entire gastric mucosa. The stated timeframe is 45 minutes. This outcome focuses on what the endoscopist can see during the procedure, which is directly aligned with the study's question about the use of prokinetic drugs before endoscopy for upper gastrointestinal bleeding.
As a general matter, an endpoint should translate a research question into an outcome that can be assessed consistently. Complete visualization might be recorded in different ways, but the registry record does not report the endpoint's operational definition, scoring method, assessor, or data format. It also does not report whether the assessment was made at one precisely specified procedural moment within the timeframe or how incomplete or indeterminate assessments would be handled. These details matter because consistent definitions reduce variation in measurement and help readers understand what a group comparison represents.
The registry gives no primary-outcome results, and the study description explicitly says no study data are available. It is therefore not possible to report the frequency of complete visualization in any group, estimate a difference between groups, or assess the precision of such a difference. The endpoint's rationale can be described from the study question, but its observed value and comparative result are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted record does not provide an estimate of the primary endpoint. It says no study data are available, and the analysis count is 0. There are no reported group results from which to assess whether the entire gastric mucosa was visualized, or whether visualization differed between erythromycin, metoclopramide, and control. The clinical question therefore has no answer in the registry's results.
The recorded enrollment is 4, but enrollment alone is not an outcome. The record does not state the number randomized to each arm, the number assessed for the primary endpoint, or whether anyone was excluded from an analysis. It would be inappropriate to infer outcomes, group balance, or the amount of missing outcome data from the enrollment figure.
The adverse-event record lists zero for the displayed serious and other event counts and zero deaths in each of the three named groups. However, the record also says no study data are available. Those zero entries should not be interpreted as evidence that no adverse events or deaths occurred; the registry does not explain how these fields were populated in relation to the unavailable study data. No serious adverse-event terms are listed. An absence of reported events is not the same as a documented finding of no events.
There is no estimate, confidence interval, or p-value for the primary comparison in the record. A confidence interval, in general, describes the range of effect values compatible with the data and the method used; it cannot be interpreted when the underlying estimate and analysis are absent. Likewise, no conclusion about statistical significance can be drawn without a reported analysis. The registry includes secondary outcome names, but does not report their results or analyses.
The study's terminated status and the stated loss of contact with the study team help explain why results are unavailable; they do not reveal what the results would have been. The record does not report the reason for termination beyond the information about the principal investigator leaving and unsuccessful contact efforts. No treatment-effect estimate should be substituted for the unavailable analysis, and the record does not support a claim that either intervention was beneficial, ineffective, or equivalent to control.
Any planning illustration based on an observed effect would require an outcome estimate, but no study data or effect estimate is reported. Thus, such an illustration cannot serve as a reconstruction of the trial's design or as evidence about its results. The record does not report a protocol-based sample-size justification or a completed statistical analysis.
9. Statistical Methods Explained
General explanation: randomized allocation is used to create comparison groups whose baseline characteristics are less systematically related to treatment assignment than they might be in a nonrandomized comparison. This supports causal interpretation when allocation is implemented as intended and when follow-up, outcome measurement, and analysis are also appropriate. Randomization does not guarantee that groups will be identical, especially in a small study. The registry record calls this study randomized, but does not report its sequence-generation method, allocation concealment, or group assignments. Without those details or results, the impact of randomization cannot be evaluated.
General explanation: masking can reduce the chance that expectations about a treatment influence behavior or outcome assessment. The registry calls the study double-masked, but does not identify which people were masked or describe how masking was maintained. Since the primary outcome involves visualization during endoscopy, details about who assessed it and whether the assessment was masked would help readers judge the possibility of measurement or observer effects. Those details are not reported in the registry record.
The design is described as factorial, but the factorial structure is not reported. In general, a factorial design studies more than one treatment factor within a common study structure and may estimate effects for each factor, combinations of factors, or interactions between factors. An interaction asks whether the effect associated with one factor differs according to the level of another factor. These distinctions affect which treatment contrasts are appropriate and how results should be interpreted. The registry's intervention and arm descriptions name erythromycin, metoclopromide, and control, but do not establish the factor levels, combined-treatment groups, or intended contrasts. A factorial analysis should not be presumed from the label alone.
The primary outcome asks whether the entire gastric mucosa can be visualized, with a timeframe of 45 minutes. General statistical practice requires a clear definition of the outcome and a consistent assessment procedure before choosing an analysis. For a categorical outcome, a comparison might summarize proportions; for a numerical score, it might compare distributions or averages; other forms of outcome require other methods. These are general examples, not descriptions of the method used in this study. The registry does not report the endpoint format, analysis method, adjustment variables, or a primary effect measure. It is therefore not possible to determine whether the planned analysis matched the data or to reproduce it.
General explanation: estimates should usually be interpreted alongside their uncertainty. A confidence interval communicates the precision of an estimate under the model and assumptions used. A p-value addresses compatibility between the data and a specified null hypothesis under an analysis model; it does not measure the size or clinical importance of an effect. Neither is reported for this study. No effect estimate is available from which to assess precision, and no test result is available from which to discuss statistical evidence.
Over-dispersion is a general concern when count data vary more than a statistical model assumes. If present, it can make model-based uncertainty too small and tests too optimistic unless the analysis accounts for that extra variation. The registry lists blood units transfused among the secondary outcomes, but does not report its outcome format, distribution, or analysis. There is no basis for saying over-dispersion occurred or that any particular count model was used. Similarly, the listed mortality and second-look endoscopy outcomes do not establish that a time-to-event or other specialized analysis was performed.
Planning sample sizes from an observed effect is a general exercise that asks how much information might be needed to detect an effect under specified assumptions. It is not an analysis of treatment efficacy, and it is not observed power. The registry's planning assumptions refer to a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and an effect defined as a fraction of the observed effect. But no observed effect is reported, and the primary outcome is not reduced to one comparison in the analysis information. Any planning illustration cannot be interpreted as a result or as evidence of the trial's original design rationale. The record does not report a protocol-based sample-size justification.
Reproducible interpretation also depends on knowing the analysis population, handling of missing outcomes, covariate adjustment, and the treatment of protocol deviations. The registry does not report these methods. Because no study data are available and the analysis count is 0, the posted record cannot support a reanalysis or a check of assumptions. These are limits of what can be concluded, not evidence that a particular method was or was not used outside the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The record describes a factorial model and names a primary outcome plus secondary outcomes of source of bleeding, second-look endoscopy, blood units transfused, and mortality. It also records 6 outcome measures, but does not identify the full set of measures or provide analyses. The analysis count is 0. The planned set of statistical hypotheses, the ordering of outcomes, and any multiplicity adjustment are not reported in the registry record.
General explanation: when researchers test several outcomes or comparisons, the chance of obtaining at least one apparently unusual result can increase if each test is considered separately. A prespecified analysis plan can identify primary comparisons and explain whether or how multiplicity is addressed. In factorial studies, the number and interpretation of comparisons also depend on the planned treatment contrasts and interaction questions. The record does not provide enough information to determine which comparisons were intended or whether multiplicity methods were considered.
The record says no study data are available. It does not report the number of participants with an assessed primary outcome, the completeness of secondary outcome data, or reasons for any missing assessments. The recorded enrollment of 4 cannot be treated as the number analyzed for any outcome. The analysis population is not reported: there is no statement of whether an analysis would include all randomized participants, participants who received assigned treatment, or another group.
General explanation: missing outcomes can affect interpretation when their occurrence is related to treatment assignment, prognosis, or the outcome itself. Statistical approaches to missing data rely on assumptions that should be made explicit. Here, neither the extent nor the pattern of missing outcome data is reported, so no missing-data assumption or correction can be evaluated. The record also does not report interim analyses, stopping rules, protocol deviations, or a statistical analysis plan. These absences prevent assessment of how multiplicity and missingness would have been handled; they do not establish what happened outside the registry record.
11. What the Result Does, and Does Not, Mean
The registry record establishes that a randomized, double-masked study was registered to compare erythromycin and metoclopramide with control before endoscopy for upper gastrointestinal bleeding. It describes a primary question about visualization of the entire gastric mucosa, specifies a 45 minutes timeframe, lists secondary outcomes, and records the study as terminated. It also records enrollment of 4.
Those design and status details do not constitute evidence of an intervention effect. No study data are available, and no analyses are reported. The record therefore does not show whether complete visualization occurred, how often it occurred in any group, or whether the groups differed. It does not support conclusions about uncertainty, statistical significance, or the size of an effect. Nor does it show that the interventions and control were equivalent.
The adverse-event entries with zeros are not a substitute for safety results when the record states that no study data are available. They cannot establish that adverse events or deaths did not occur. Likewise, listing secondary outcomes does not mean those outcomes were measured or analyzed.
General explanation: a trial's design can clarify the question it was intended to address, while its results require observed outcome data and a reported analysis. When results are unavailable, readers can describe the planned comparison and the limits of the record, but cannot fill the gap with assumptions or with the expected mechanism of an intervention. The information supports a description of the study and its incompleteness, not a judgment about the effects of either drug.
12. Why This Trial Matters Statistically
This record is a useful reminder that a randomized design and a clinically focused endpoint do not by themselves provide evidence about an intervention. The study set out to compare two prokinetic drugs with control for visualization of the entire gastric mucosa during endoscopy, but the registry says it was terminated and that no study data are available. Without outcome data, the intended comparison cannot be estimated.
Statistically, the absence of results also means that precision cannot be assessed. There is no reported group estimate to pair with a confidence interval, no analysis to evaluate, and no basis for determining whether observed differences—if any—would be compatible with chance or important in practice. The recorded enrollment of 4 does not resolve these issues: allocation by group and the availability of outcome assessments are not reported.
The factorial designation makes reporting of the planned contrasts particularly important. In general, interpretation depends on knowing whether the question concerns separate treatment effects, combinations, or interactions. The registry does not describe those details, and no analyses are reported. The study therefore cannot illustrate how those contrasts behaved in observed data.
The record also demonstrates why registry entries should distinguish design information from results. Intervention descriptions and outcome names identify what was intended, while efficacy and safety conclusions require data and analysis. The zero entries in the adverse-event record should be read cautiously because the same record states that study data are unavailable. The most defensible statistical conclusion is that the registered question remains unanswered in the posted results.
13. 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 no study data are available. The registry attributes this to termination of the study and the principal investigator leaving the institution; efforts to contact the investigator or study team were unsuccessful. The record does not report a reason for termination beyond these statements, nor does it report whether any outcomes were collected before termination.
Although enrollment is recorded as 4, the distribution across groups, number randomized, number undergoing endoscopy, and number assessed for the primary endpoint are not reported. No participant characteristics are available to describe the study population beyond the condition of upper gastrointestinal bleeding. The record does not report eligibility criteria or details needed to assess how broadly the intended population was defined.
The primary outcome's operational definition and data format are not reported. The timing is stated as 45 minutes, but the record does not explain how complete visualization was assessed or who assessed it. The factorial structure and intended comparisons are also not described. These omissions limit understanding of the proposed analysis even apart from the absence of results.
The registry lists secondary outcomes, but does not report results for them. It also does not report the analysis population, missing-data handling, protocol deviations, randomization procedures, masking details, or a statistical analysis plan. The adverse-event fields show zeros for the listed groups, but the record's statement that no study data are available means those entries cannot be treated as documented evidence of event-free follow-up. These limitations prevent estimates of benefit, harm, or uncertainty from the registry record.
14. Related Tutorials
15. Related Statistical Calculators
16. Sources
- ClinicalTrials.gov: Randomized Control Trial Comparing Prokinetics and Their Influence on Endoscopy Outcomes for Upper GI Bleed. — NCT02017379.
- Registry record last updated 2021-03-04; status last verified 2021-02.
- Results first posted 2021-03-04.
- 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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17. Record Summary
The registry record describes NCT02017379, a randomized, double-masked study with a factorial model in upper gastrointestinal bleeding. It compares intravenous erythromycin, intravenous metoclopromide, and a control described as receiving no medication before endoscopy. The primary question concerns visualization of the entire gastric mucosa at a 45 minutes timeframe. Listed secondary outcomes include source of bleeding, second-look endoscopy, blood units transfused, and mortality.
Enrollment is recorded as 4; the study phase is listed as NA. The recorded start is 2014-06, primary completion is 2014-09, and status is terminated. The registry states that the principal investigator left the institution, contact efforts were unsuccessful, and no study data are available. No analyses are reported. Consequently, there is no posted estimate of the primary or secondary outcomes and no basis for an efficacy or safety comparison.