Multicenter Randomized Parallel Group Phase III Study Comparing the Bowel Cleansing Efficacy, Safety and Tolerability of NER1006 Versus MOVIPREP® Using 2-Day Split-Dosing and 1-Day Morning Split-Dosing Regimen in Adults.: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Multicenter Randomized Parallel Group Phase III Study Comparing the Bowel Cleansing Efficacy, Safety and Tolerability of NER1006 Versus MOVIPREP® Using 2-Day Split-Dosing and 1-Day Morning Split-Dosing Regimen in Adults. (NCT02273167), a randomized phase 3 study. The primary outcome is Number of Patients With Successful Bowel Cleansing (Overall Colon).

2. Clinical Question

The trial also lists adenoma detection and polyp detection outcomes for the ascending colon and overall colon. Those measures address what was detected during colonoscopy, while the primary endpoint concerns the quality of bowel cleansing. These are related aspects of the procedure but are not interchangeable outcomes.

The clinical question is therefore about a specific comparison of cleansing regimens and timing, rather than a general comparison of all bowel preparations. The two NER1006 schedules differ from the MOVIPREP schedule in both the preparation used and, for one NER1006 group, the timing of dosing. Because the registry does not give primary outcome results by group, the relative success of these regimens cannot be described from this record.

3. Trial Design

This was a randomized, parallel-group phase III study with single masking. It compared three regimens: NER1006 with 2-Day Split-Dosing, NER1006 with 1-Day Morning Split-Dosing, and MOVIPREP with 2-Day Split-Dosing. The trial is marked completed. The registry lists 849 participants enrolled; its brief summary had described a plan to randomize approximately 810 patients, with a minimum of 245 patients in each of the 3 groups.

Randomization assigns participants to treatment groups by chance, which is intended to reduce systematic differences between groups at the outset. In a parallel-group design, participants remain in the assigned group rather than crossing over to another regimen. The registry does not report the randomization sequence method, allocation concealment, or other implementation details.

Single masking means that some aspect of treatment assignment was masked, but the registry record does not identify who was masked. For the primary outcome, it does specifically state that a blinded central reader—an experienced and trained colonoscopist—assessed cleansing using the Harefield Cleansing Scale. This central assessment is relevant because the endpoint depends on interpretation of colonoscopy findings.

The primary comparison was designed as a non-inferiority assessment of each NER1006 regimen against MOVIPREP. The record does not report the non-inferiority margin, the planned statistical analysis details, or the numerical results. The study began in 2014-10, and primary completion is recorded as 2015-08. The sponsor is Norgine. The population was adults requiring cleansing before a procedure that requires a clean bowel, according to the brief summary.

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: The overall number of participants analyzed was based on the mFAS. This included all randomized patients, except any patient who (i) was randomized but subsequently failed to meet entry criteria and (ii) in whom it was confirmed (from their patient diary) that the same patient did not receive any study drug.

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 number of participants for analysis, 245 per arm, was based on assumed overall cleansing success rates of 90% for both MOVIPREP and NER1006, a non-inferiority margin of 10%, and at least 90% power to demonstrate non-inferiority. The overall number of participants analyzed was based on the modified full analysis set (mFAS).

6. Primary Endpoint

The registry lists the primary outcome as Number of Patients With Successful Bowel Cleansing (Overall Colon), measured over Up to 2 days (from day of first dosing to day of colonoscopy).

The primary endpoint is the number of participants with successful bowel cleansing of the overall colon. The assessment used segmental Harefield Cleansing Scale scores, from which a final grade of A, B, C, or D was derived. Grades A and B counted as successful; grades C and D counted as unsuccessful. The registry describes success as a result in which all mucosa could be visualized.

A central reader who was an experienced and trained colonoscopist assessed the cleansing. Central, blinded reading can help make outcome assessment more consistent and reduce the chance that knowledge of treatment assignment influences grading. The record does not give further details about the reader process or how disagreements, if any, were handled.

The outcome was assessed up to 2 days, from the day of first dosing to the day of colonoscopy. Bowel cleansing is directly relevant to the procedure because the endpoint is based on how much mucosa can be visualized. The endpoint is binary for the stated primary classification: each participant is categorized as successful or unsuccessful. That makes the group comparison a comparison of participant counts or proportions, although the registry does not report those primary outcome counts or proportions.

The registry states that overall success with both NER1006 schedules was evaluated against MOVIPREP using a non-inferiority design. A non-inferiority question asks whether an intervention’s outcome is not unacceptably worse than the comparator under a prespecified margin. The margin and the evidence needed to assess it are not reported in the registry record, so the primary endpoint’s observed result cannot be interpreted from the available record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The trial’s stated primary approach is non-inferiority. In general, a non-inferiority study asks whether an intervention’s outcome is not worse than a comparator by more than a prespecified amount. That amount is called the non-inferiority margin. It represents the largest disadvantage that the study’s design considers compatible with non-inferiority. The margin is essential to interpretation because a result cannot be judged against the design’s criterion without knowing it. The margin is not reported in the registry record.

What does a confidence interval add?

In general, a confidence interval describes uncertainty around an estimated effect. A narrow interval indicates greater precision than a wide interval, while both the estimate and interval’s position relative to the non-inferiority margin matter for a non-inferiority conclusion. A point estimate alone would not describe that uncertainty. The registry record does not report a primary effect estimate or its confidence interval, so neither the direction nor the precision of the primary comparison can be assessed.

How does randomization contribute?

In general, random allocation helps balance measured and unmeasured characteristics between groups on average, reducing confounding in a comparison of assigned interventions. It does not guarantee identical groups, and it does not prevent bias from missing outcomes, departures from assigned treatment, or outcome assessment. This study is recorded as randomized and parallel-group. The registry does not report details of the sequence generation or allocation concealment, so those implementation features cannot be evaluated from this record.

Why does outcome assessment matter?

The primary endpoint depends on grading colon cleansing using segmental scores from the Harefield Cleansing Scale. The record states that a blinded central reader, an experienced and trained colonoscopist, made the assessment. In general, masking an assessor can reduce the potential for expectations about treatment to affect outcome classification. The scale’s final grades were grouped into success, grades A and B, and failure, grades C and D. The registry does not describe whether or how reader agreement was assessed.

What do binary outcome analyses usually compare?

In general, a binary outcome records whether each participant did or did not experience a defined event. Here, the primary event is successful bowel cleansing. A group comparison can be expressed through participant counts, proportions, or a contrast between those proportions. The chosen effect measure and statistical model should be reported because different measures answer the comparison in different forms. The record provides no primary group counts, effect measure, model, or uncertainty estimate. No such comparison can be reconstructed from the safety counts.

How should sample-size illustrations be read?

In general, a sample-size illustration based on an observed effect explores the number of participants that might be needed under stated assumptions. It is a planning exercise, not a measure of the trial’s observed power and not evidence that an effect is real. The record describes an illustration based on the observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the effect to detect is described as a stated fraction of the observed effect. The record also distinguishes participant-per-arm planning for non-time-to-event outcomes from total-event planning for time-to-event outcomes. Such an illustration does not replace the trial’s own design rationale, which is not reported in the registry record.

In general, over-dispersion matters when observed variation is greater than the model assumes: standard errors may then be too small if the extra variation is ignored. That concern applies only where the outcome and analysis model warrant it. The primary endpoint is binary, but the model used is not reported, so it would be inappropriate to claim that over-dispersion was assessed or relevant to the actual analysis.

The registry record lists 6 outcome measures and 12 analyses, but does not provide a full statistical analysis plan. It does not report the actual tests, model specifications, confidence level, handling of missing data, or multiplicity adjustment for the primary analysis. General statistical concepts clarify what would be needed to interpret the design; they do not fill in those missing trial-specific methods.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists a primary outcome and secondary outcomes covering adenoma detection and polyp detection in the ascending colon and overall colon. It also records 6 outcome measures and 12 analyses. Multiple outcomes or analyses can create multiplicity: when many hypotheses are tested, the chance of at least one apparently positive result can rise unless the analysis plan accounts for that structure. In general, a prespecified testing hierarchy or statistical adjustment may help control that risk. The registry record does not report a multiplicity strategy, so it is not possible to determine how the listed analyses were handled.

The primary endpoint analysis population is described as the modified full analysis set, or mFAS. The available description says it included randomized patients, except for patients who failed entry criteria and patients for whom it was confirmed from the patient diary that the same patient did not receive any study treatment. The population description is truncated, so its full definition is not reported in the registry record. The number analyzed in each group is also not reported.

Missing outcome data can affect both the estimate and its precision. In general, interpretation depends on how much data are missing, why they are missing, and how the analysis handles them. The registry does not report primary endpoint missingness, imputation methods, sensitivity analyses, or whether all randomized participants with available outcomes were included. It also does not provide enough detail to compare analysis populations. These omissions matter especially for non-inferiority studies, where analysis choices and departures from treatment can affect interpretation. No conclusion about those issues can be made from the registry record.

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 1% reporting threshold.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: procedural intestinal perforation (0.4%), alcohol abuse (0.4%).

The safety figures list serious adverse events and other adverse events separately for the three treatment groups. Serious adverse events are recorded for MOVIPREP 2-Day Split-Dosing, NER1006 2-Day Split-Dosing, and NER1006 1-Day Morning Split-Dosing as 0, 2, and 0 participants, respectively. Other adverse events are recorded as 31, 41, and 49 participants, respectively. These are descriptive counts, not adjusted comparisons.

The figures also give the number at risk for each category: 263 for MOVIPREP serious and other adverse events, 262 for NER1006 2-Day serious and other adverse events, and 269 for NER1006 1-Day Morning serious and other adverse events. The registry does not report comparative statistical tests or confidence intervals for these safety counts. It is therefore not possible to determine from these figures alone whether the observed differences reflect a reliable difference between regimens.

The registry lists “Procedural intestinal perforation” and “Alcohol abuse” among the top serious adverse event terms, each at 0.4%. The group attribution for these terms is not reported in the registry record. Death counts are not reported in the registry record. Adverse event counts are safety observations and should not be treated as evidence about the primary cleansing outcome.

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

The record describes a randomized phase III comparison of two NER1006 dosing schedules with MOVIPREP given by a 2-Day Split-Dosing regimen. Its primary question is whether the NER1006 schedules are non-inferior to MOVIPREP for successful cleansing of the overall colon. The outcome definition is clear: grades A and B on the Harefield Cleansing Scale count as successful, while grades C and D count as unsuccessful.

What the record does not establish is the answer to that question. It reports no primary outcome group counts, estimates, confidence intervals, or non-inferiority margin. Without those elements, it is not possible to determine whether either NER1006 regimen met the non-inferiority criterion, how large any observed difference was, or how precisely the comparison was estimated. A study’s design and endpoint definition are not themselves outcome findings.

The safety counts offer limited descriptive information, but they do not supply a complete comparative safety assessment. The record does not report statistical comparisons or confidence intervals for those figures, and the serious-event term list does not identify treatment groups. The secondary detection outcomes are listed without numerical findings. These gaps mean that the registry record does not support broader claims about comparative efficacy, detection, or safety.

The posted information is useful for understanding the trial structure, the regimens, the endpoint, and the intended non-inferiority question. It is not enough to resolve that question. Interpretation should remain confined to what is recorded: a completed, randomized, parallel-group study with a blinded central outcome reader and reported safety counts, but without the primary efficacy results required for a statistical conclusion.

13. Why This Trial Matters Statistically

This trial raises a useful statistical distinction between a study’s design and its findings. The registry specifies a randomized, parallel-group phase III comparison and identifies a non-inferiority question. Those features explain what the investigators intended to test; they do not show whether the criterion was met. A non-inferiority conclusion requires both an estimated comparison and a prespecified margin, neither of which is reported in the registry record.

The endpoint also illustrates how outcome definitions shape a trial. Cleansing was graded using a scale, then grouped into successful and unsuccessful categories. That binary classification makes the primary question understandable, but the group-level data and uncertainty are needed to know what the comparison showed. Clear definitions cannot substitute for results.

Another statistical lesson concerns analysis populations and missing data. The record names a modified full analysis set but supplies only a partial definition. In a non-inferiority study, readers need to know who entered each analysis and how missing or incomplete outcomes were handled to assess robustness. Those details are not reported in the registry record.

Finally, descriptive safety counts should not be mistaken for comparative evidence. Counts can alert readers to recorded events, but interpretation also depends on denominators, event definitions, follow-up, and uncertainty. The record gives some of these descriptive figures but not a comparative statistical analysis. Overall, this study’s record demonstrates why design information, endpoint rules, analysis details, and numerical outcomes all contribute to a defensible statistical interpretation.

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 principal limitation for interpreting this trial from the registry record is the absence of numerical primary outcome results. The record defines success and states the non-inferiority objective, but does not report group-level counts, estimates, confidence intervals, or the non-inferiority margin. The primary comparison therefore cannot be evaluated.

The primary analysis population is described only partially. The available mFAS definition excludes some randomized patients, but the rest of the description is truncated. The group-specific analysis populations, missing primary assessments, and methods for handling missing data are not reported in the registry record. These details limit assessment of how the analysis relates to random assignment and how sensitive results might be to exclusions.

The registry does not report the statistical analysis plan, the test or model used for the primary endpoint, or how multiplicity across the listed analyses was addressed. It also does not give the randomization procedure or allocation concealment details. Although the outcome assessor is described as blinded, the record does not identify who else was masked.

Safety information is also limited to reported counts and selected serious event terms. Comparative estimates, uncertainty, event timing, and treatment-group attribution for the listed serious event terms are not reported. Death counts are not reported in the registry record. These limitations concern what can be learned from this record; they do not establish that the underlying trial lacked further analyses or documentation.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Multicenter Randomized Parallel Group Phase III Study Comparing the Bowel Cleansing Efficacy, Safety and Tolerability of NER1006 Versus MOVIPREP® Using 2-Day Split-Dosing and 1-Day Morning Split-Dosing Regimen in Adults. — NCT02273167.
• Registry record last updated 2018-05-15; status last verified 2018-04.
• Results first posted 2017-04-18.
• 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

NCT02273167 is a completed, randomized, single-masked, parallel-group phase III study sponsored by Norgine. It enrolled 849 participants. The study compared NER1006 using 2-Day Split-Dosing or 1-Day Morning Split-Dosing with MOVIPREP using 2-Day Split-Dosing.

The primary endpoint was successful cleansing of the overall colon, assessed by a blinded central reader using Harefield Cleansing Scale grades. The registry identifies non-inferiority as the primary comparison but does not report the outcome results or non-inferiority margin. It lists adenoma and polyp detection outcomes as secondary measures. Safety counts are reported, but comparative safety analyses are not. The primary efficacy conclusion cannot be determined from the registry record.