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 Study of Metoclopramide in Small Bowel Capsule Endoscopy (NCT01630109), a randomized phase 4 study. The primary outcome is Difference in Treatment vs. Placebo in Pill Capsule Completion Rates.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01630109 |
| Phase | Phase 4 |
| Condition | Pill Capsule Endoscopy Completion Rates |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Double |
| Enrollment | 5 |
| Arms in the primary outcome | 3 |
| Lead sponsor | Ascension Health |
| Results posted | Yes |
2. Clinical Question
Population
Patients undergoing small bowel capsule endoscopy. The registry record lists enrollment of 5 and does not provide further eligibility details or a more specific description of the participant population.
Intervention
Metoclopramide given before the Pill Cam was swallowed: 5 mg or 10 mg, described as a pro-motility agent. The brief summary specifies administration 30 minutes before swallowing the capsule.
Comparator
Placebo control. The study is described as randomized, double-blind, and placebo-controlled, with a parallel design.
Primary question
Does capsule completion within 12 hours differ between metoclopramide and placebo, and between the 5 mg and 10 mg doses? The primary endpoint is the percentage of complete capsule studies.
The clinical question concerns whether giving metoclopramide before capsule endoscopy is associated with a different chance of completing the capsule study within the stated timeframe. The registry also describes interest in gastric and small bowel transit times and in completion rates among participants with and without diabetes.
The posted primary results are completion percentages for each randomized arm: 100.0% for Metoclopramide 5 mg, 0.0% for Metoclopramide 10 mg, and 100.0% for placebo. The corresponding arm sizes are 1, 1, and 3. These results are descriptive and come from a very small enrolled group. They do not provide a precise estimate of how completion rates compare in a broader population.
The registry record does not report a formal treatment comparison, a confidence interval, or a statistical test for the primary endpoint. It also does not report results for gastric transit time, small bowel transit time, or completion rates by diabetes status. The clinical question is therefore broader than the results available to assess: the posted completion percentages address only part of the stated study aims.
3. Trial Design
The registry describes a Phase 4, randomized, double-blind, parallel study with placebo control. Participants undergoing small bowel capsule endoscopy were to be assigned to Metoclopramide 5 mg, Metoclopramide 10 mg, or placebo. The brief summary states that the study medication was given 30 minutes before the participant swallowed the Pill Cam. Ascension Health is listed as the sponsor, and the study status is completed.
The registry lists enrollment of 5. The posted outcome groups contain 1 participant in the 5 mg arm, 1 participant in the 10 mg arm, and 3 participants in the placebo arm. These small arm sizes mean that an individual participant’s outcome has a substantial influence on the percentage reported for that arm. Randomization and masking describe the planned design, but they do not by themselves make the observed percentages precise.
The study’s primary outcome is the difference in treatment versus placebo in pill capsule completion rates, with the measure described as the percentage of complete capsule studies and a timeframe of 12 hours. The description also says the study is looking at differences between the two metoclopramide doses. Secondary outcomes listed in the registry concern gastric transit time, small bowel transit time, and completion rates in diabetic versus non-diabetic participants.
The registry record does not report the randomization procedure, allocation concealment, details of who was masked, eligibility criteria, or a protocol-level sample-size justification. It also does not report a statistical analysis plan, planned interim analyses, or analysis populations. Those details cannot be inferred from the designation of the study as randomized and double-blind.
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.
Before assignment: No events to report.
Overall Study
| Stage | Metoclopramide 5 mg | Metoclopramide 10 mg | Placebo Control |
|---|---|---|---|
| STARTED | 1 | 1 | 3 |
| COMPLETED | 1 | 1 | 3 |
| NOT COMPLETED | 0 | 0 | 0 |
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 | Metoclopramide 5 mg | Metoclopramide 10 mg | Placebo Control | Total |
|---|---|---|---|---|---|
| Participants analysed | 1 | 1 | 3 | 5 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 1 | 1 | 3 | 5 |
| Age, Categorical: >=65 years | Participants | 0 | 0 | 0 | 0 |
| Age, Continuous | years | 54 (SD 0) | 59 (SD 0) | 46 (SD 12.76) | 50.20 (SD 10.84) |
| Sex: Female, Male: Female | Participants | 0 | 0 | 2 | 2 |
| Sex: Female, Male: Male | Participants | 1 | 1 | 1 | 3 |
| Region of Enrollment: United States | participants | 1 | 1 | 3 | 5 |
6. Primary Endpoint
The registry lists the primary outcome as Difference in Treatment vs. Placebo in Pill Capsule Completion Rates, measured over 12 hours.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | percentage of complete capsule studies |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is the percentage of complete capsule studies within 12 hours. A capsule study is counted in terms of whether the capsule examination was completed during the specified timeframe. The endpoint is intended to capture whether the capsule traversed the small bowel sufficiently for the study to be considered complete, rather than measuring transit time alone.
Completion is used because the study’s stated aim is to assess whether metoclopramide affects the rate at which capsule examinations are completed. A completion percentage can describe the proportion of participants meeting the endpoint in each arm. It is distinct from gastric transit time and small bowel transit time, which are listed as separate outcomes and would describe timing rather than completion status.
The posted percentages are 100.0% for Metoclopramide 5 mg, 0.0% for Metoclopramide 10 mg, and 100.0% for placebo. The respective arm sizes are 1, 1, and 3. With such small groups, these percentages give a limited basis for estimating the underlying completion rates. In particular, a percentage from an arm with 1 participant reflects that participant’s outcome and should not be treated as a stable estimate for a wider patient population.
The registry record does not give additional operational details about how completion was defined or adjudicated, nor does it report endpoint-level missingness. The endpoint’s stated timeframe is 12 hours; further specification is not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted primary outcome is descriptive. Capsule completion was recorded for 100.0% of the Metoclopramide 5 mg arm, 0.0% of the Metoclopramide 10 mg arm, and 100.0% of the placebo arm. The group sizes were 1, 1, and 3, respectively. These percentages describe what happened among the participants represented in each group; they do not, by themselves, establish a treatment effect or a reliable difference in completion rates.
The arm sizes are central to interpretation. When an arm contains only 1 participant, its percentage depends entirely on that participant’s outcome. The placebo percentage is based on 3 participants, still a small group. A change in the outcome of an individual would substantially alter a percentage in a group this small. Consequently, the apparent contrast between the 10 mg and other arms is highly uncertain as an estimate of what might occur in a larger group.
The registry record reports no statistical analyses for the outcome. It contains no treatment-effect estimate, confidence interval, or p-value. A confidence interval would ordinarily communicate the range of values compatible with the observed data under a specified method; without one, the precision of any between-group difference is not quantified in the posted results. No formal comparison can be reconstructed from the posted summary in this record, and no recalculated comparison is presented.
The results also do not resolve the study’s other stated questions. The registry lists gastric transit time, small bowel transit time, and completion rates by diabetes status as secondary outcomes, but numerical findings for those outcomes are not reported in the registry record. The completion percentages therefore should not be interpreted as evidence about transit times or about a possible difference between diabetic and non-diabetic participants.
In short, the recorded percentages show variation across the three arms in this small enrolled group. They do not indicate how precisely the true completion rates are estimated, whether the observed pattern is reproducible, or whether any difference is attributable to treatment. The registry record does not report an inferential analysis that would support those conclusions.
9. Statistical Methods Explained
The study is described as randomized, double-blind, parallel, and placebo-controlled. These design features address different aspects of a trial. Randomization is intended to assign participants to treatment groups by chance, helping reduce systematic differences between groups. Masking is intended to limit the influence of treatment knowledge on participant experience, care, or outcome assessment. A parallel design means participants are assigned to a group rather than receiving each study treatment in sequence. These general explanations do not establish how the procedures were implemented in this study; detailed procedures are not reported in the registry record.
What does the primary percentage represent?
The primary outcome is the percentage of complete capsule studies within 12 hours. For each arm, the posted percentage describes the observed completion outcome among the participants recorded in that arm. The reported values are 100.0% for Metoclopramide 5 mg, 0.0% for Metoclopramide 10 mg, and 100.0% for placebo. Because the arm sizes are 1, 1, and 3, these percentages carry little information about the range of outcomes that could occur in a broader population. An observed percentage is a point estimate, not a guarantee that the underlying rate equals that value.
Why does uncertainty matter?
Statistical uncertainty describes how much an estimate may vary because it is based on a limited set of observations. A confidence interval is a conventional way to express uncertainty around an estimate, conditional on the method and assumptions used. Wider intervals generally indicate less precision. The registry record does not report confidence intervals for the primary outcome, and it does not report a formal comparison between treatment arms. The posted percentages therefore cannot show the precision of the treatment contrasts.
Small groups make uncertainty particularly important. With an arm size of 1, a single observed outcome determines the arm’s completion percentage. This is a general property of proportions in very small samples, not a separate finding about the biological effect of either dose. The placebo group also contains only 3 participants, so its percentage is based on limited information. Comparisons among these groups are accordingly descriptive rather than persuasive estimates of population differences.
What would a formal comparison add?
A formal comparison would estimate how completion differs between specified groups and quantify uncertainty using a statistical method appropriate to the design and outcome. It could also state how the analysis handles the two metoclopramide doses, whether the doses are compared separately with placebo, and whether any adjustment is made for multiple comparisons. Those methods and results are not reported in the registry record. The record lists 0 analyses, so no inferential result such as a p-value or treatment-effect interval is available to interpret.
The primary outcome is a binary status summarized as a percentage, but the registry labels its result format as a count-type outcome. The record does not provide a model specification or enough analysis details to identify a particular statistical test. No statistical test should be inferred solely from the fact that the trial was randomized.
How should sample-size illustrations be read?
Any sample-size illustrations associated with the posted results are planning illustrations based on the observed effect, under stated assumptions. They are not the trial’s original sample-size calculation and are not observed power. A planning calculation asks how many participants might be needed for a future study to detect a chosen effect under specified assumptions. It does not change the uncertainty in the current trial, and it cannot establish that the current study was adequately sized. The registry record does not report the original sample-size justification or the assumptions used to plan enrollment.
Over-dispersion is a general concern when observed outcomes vary more than a statistical model expects. If present, it can make uncertainty estimates based on a simpler model too small. The registry record does not report a model or enough participant-level data to assess over-dispersion here, and this endpoint’s posted arm summaries do not support such an assessment. More generally, the appropriate analysis depends on the outcome definition, design, and prespecified plan; those details are not available in the registry record.
What can and cannot be inferred?
The arm percentages show the outcomes recorded in this small study, while the randomized design describes how treatment assignment was intended to occur. Neither fact alone establishes a precise treatment effect. Without a reported analysis plan, comparison estimate, uncertainty interval, or endpoint-level participant data, readers cannot assess adjustment choices, model fit, or sensitivity to missing outcomes. The statistical interpretation should therefore remain limited to the descriptive results actually reported.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists a primary completion outcome and secondary outcomes concerning gastric transit time, small bowel transit time, and capsule completion by diabetes status. Considering multiple outcomes or multiple treatment comparisons can raise the chance of obtaining at least one apparently notable result by chance. General approaches include defining a primary comparison in advance, adjusting for multiplicity, or treating secondary analyses as exploratory. The registry record does not report whether any such approach was planned or used.
The primary outcome description covers treatment versus placebo and also refers to comparing the 5 mg and 10 mg doses. The record does not specify which pairwise comparisons were prespecified, how those comparisons were ordered, or whether any multiplicity adjustment was applied. It reports 0 analyses, so no adjusted or unadjusted inferential results are available.
Missing data can affect interpretation if outcome status is unavailable for some randomized participants. The record does not report missing outcome counts, reasons for missingness, or how missing observations were handled. The posted arm sizes and percentages do not establish whether every randomized participant contributed an evaluable endpoint. No missing-data method or sensitivity analysis is reported in the registry record.
The analysis populations are also not described. For example, the registry record does not state whether the primary outcome was analyzed according to randomized assignment or among participants who completed the procedure. The record does not report a statistical analysis plan, so the intended population and handling of deviations from assigned treatment are unknown. These omissions limit assessment of both bias and reproducibility; they should not be filled in by assumption.
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 |
|---|---|---|---|
| Metoclopramide 5 mg | 0 | 1 | 0.0% |
| Metoclopramide 10 mg | 0 | 1 | 0.0% |
| Placebo Control | 0 | 3 | 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 |
|---|---|
| Metoclopramide 5 mg | 0 of 1 |
| Metoclopramide 10 mg | 0 of 1 |
| Placebo Control | 0 of 3 |
The registry reports serious adverse events and other adverse events separately for each arm. For Metoclopramide 5 mg, 0 serious adverse events were recorded among 1 participant at risk, and 0 other adverse events among 1 participant at risk. For Metoclopramide 10 mg, the corresponding figures are 0 among 1 and 0 among 1. For placebo, they are 0 among 3 and 0 among 3.
These are event counts from the participants included in the safety record. The small numbers of participants at risk mean that the absence of a recorded event in these groups gives limited information about event frequency in a broader population. The registry record does not list any serious adverse-event terms.
The deaths fields are not populated with a numeric value. Death counts are therefore not reported in the registry record; they should not be read as zero. The safety figures are descriptive and do not establish that an event cannot occur, nor do they support a precise comparison of safety between arms.
12. What the Result Does, and Does Not, Mean
The result establishes a narrow descriptive fact about the participants recorded in the study: completion percentages differed across the treatment arms, with 100.0% in the 5 mg arm, 0.0% in the 10 mg arm, and 100.0% in placebo. The associated arm sizes were 1, 1, and 3. These observed values are the available primary-outcome results in the registry record.
They do not establish that metoclopramide changes capsule completion rates. The small groups leave substantial uncertainty about what completion rates might be in a larger population, and the registry reports no treatment-effect estimate, confidence interval, or statistical test. The percentages should not be generalized as if they were stable estimates of the underlying rates.
The results also do not establish whether the 5 mg and 10 mg doses differ from one another, or whether either differs from placebo. Although the primary outcome description names these comparisons, no formal comparison is reported. Nor do the posted completion percentages answer the questions about gastric transit time, small bowel transit time, or completion rates by diabetes status; those results are not reported in the registry record.
The record’s randomized, double-blind design describes important planned features, but the available summary does not document the detailed methods needed to assess their implementation. In particular, randomization procedures, analysis populations, missing-data handling, and the statistical analysis plan are not reported. The observations therefore support a description of the recorded sample, not a definitive conclusion about treatment effects or the reliability of the results.
13. Why This Trial Matters Statistically
This study illustrates how the scale of a trial shapes the interpretation of even a simple percentage outcome. Completion is straightforward to describe, but an arm percentage based on 1 participant is highly sensitive to that participant’s result. The reported percentages may look sharply separated, yet the small group sizes prevent them from providing precise estimates of population completion rates.
It also demonstrates why design labels and outcome values need to be read together. Randomization and double-blinding are intended to limit bias, but they cannot compensate for limited information when only a few participants contribute to the reported outcome. Nor can the design labels substitute for an analysis plan, comparison estimate, or uncertainty interval.
The registry lists several questions beyond the primary completion outcome, including transit times and completion by diabetes status. Without posted results for those outcomes, readers cannot assess whether the study’s broader aims were addressed. The absence of reported inferential analyses also means there is no basis in this record for judging the strength or precision of between-group evidence.
Statistically, the study is a useful reminder that a percentage is not self-interpreting. Its meaning depends on the number of observations, the endpoint definition, and the analysis used. Here, the percentages convey the observed outcomes in a very small sample, while leaving considerable uncertainty about patterns beyond it.
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 most direct limitation is the enrollment of 5, with outcome-group sizes of 1, 1, and 3. Such small groups provide little information for estimating completion rates or comparing arms. Percentages from the 5 mg and 10 mg groups are each based on a single participant, so they are particularly sensitive to individual outcomes.
The registry record reports no formal statistical analyses, treatment-effect estimates, confidence intervals, or p-values. It therefore does not quantify uncertainty or provide an inferential comparison. The record also does not report the original sample-size justification, randomization procedure, allocation concealment, detailed masking procedures, eligibility criteria, or statistical analysis plan.
Results for the listed secondary outcomes—gastric transit time, small bowel transit time, and completion rates by diabetes status—are not reported in the registry record. The record does not describe missing outcome data, missing-data handling, or the analysis populations. The deaths fields do not contain numeric counts, and death counts are not reported in the registry record.
Finally, the endpoint description gives a 12-hour timeframe but does not provide further operational or adjudication details. These limitations restrict what can be concluded from the posted results. They do not establish that a particular design choice or analysis was absent; such information is simply not reported in the registry record.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Study of Metoclopramide in Small Bowel Capsule Endoscopy — NCT01630109.
- Registry record last updated 2014-02-27; status last verified 2014-01.
- Results first posted 2014-02-27.
- 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.
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18. Record Summary
NCT01630109 is a completed Phase 4 study sponsored by Ascension Health, described as randomized, double-blind, parallel, and placebo-controlled. It enrolled 5 participants undergoing small bowel capsule endoscopy. The planned groups were Metoclopramide 5 mg, Metoclopramide 10 mg, and placebo.
The primary outcome was the percentage of complete capsule studies within 12 hours. The posted completion values were 100.0% for Metoclopramide 5 mg, 0.0% for Metoclopramide 10 mg, and 100.0% for placebo, with group sizes of 1, 1, and 3. The registry reports 0 analyses and does not report a formal statistical comparison or uncertainty interval.
Secondary outcomes concerned gastric transit time, small bowel transit time, and completion rates by diabetes status; their results are not reported in the registry record. Serious and other adverse-event counts were zero in the recorded groups, while death counts are not reported in the registry record. The limited sample and missing analysis details constrain interpretation of the observed percentages.