Multicenter Randomized Parallel Group Phase III Study Comparing the Bowel Cleansing Efficacy, Safety and Tolerability of NER1006 Versus a Sodium Picosulfate and Magnesium Salt Solution Using Day Before-Only 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 a Sodium Picosulfate and Magnesium Salt Solution Using Day Before-Only Dosing Regimen in Adults. (NCT02273141), a randomized phase 3 study. The primary outcome is Number of Patients With Successful Bowel Cleansing (Overall Colon).

2. Clinical Question

3. Trial Design

NCT02273141 was a randomized, single-masked, parallel-group phase III study sponsored by Norgine. The record lists enrollment of 515 and describes the study as completed. It gives a start date of 2014-11 and a primary completion date of 2015-08. The brief summary states that approximately 484 patients would be randomized, with the aim of having a minimum of 220 patients in each of the 2 groups. These are different enrollment descriptions: the record does not explain their relationship or give a reconciliation.

Participants were assigned to NER1006 or SP+MS. Both regimens used day-before-only split dosing, but their stated starting times differed: NER1006 commenced on the evening before colonoscopy, while SP+MS commenced on the morning before colonoscopy. The registry describes masking as single; who was masked is not reported in the registry record. Details of sequence generation, allocation concealment, and the operational procedures used to maintain masking are also not reported in the registry record.

The stated primary purpose was to compare overall bowel-cleansing success using a non-inferiority study design. The record identifies colorectal cancer, colorectal carcinoma, and colon cleansing among the conditions. It describes secondary outcomes involving adenoma and polyp detection in the ascending colon and overall colon. The full protocol, the rationale for the planned enrollment, and further information about trial conduct are not reported in the registry record.

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, 220 per arm, was based on assumed overall cleansing success rates of 70% for SP+MS and 75% for 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 One day (day before colonoscopy).

The primary endpoint was the number of participants with successful bowel cleansing in the overall colon. An experienced and trained colonoscopist, acting as a blinded central reader, assessed bowel cleansing using segmental Harefield Cleansing Scale scores. A final grade was derived from those scores. Grades A and B counted as successful, corresponding in the registry description to all mucosa being visible; grades C and D counted as unsuccessful. The stated timeframe was one day, the day before colonoscopy.

This endpoint gives a participant-level summary of whether cleansing met the specified success classification across the overall colon. That makes the result relevant to the study’s stated comparison of bowel-cleansing efficacy. The segmental assessment and central reader are part of the endpoint definition, while the conversion into successful or unsuccessful categories sets the rule for counting participants.

The endpoint definition alone does not show how many participants met the success criterion in either group. Those counts, the non-inferiority margin, and the uncertainty around the comparison are not reported in the registry record. Without those results, the endpoint’s operational definition can be described, but the comparative finding cannot be assessed.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does non-inferiority mean?

General statistical explanation: a non-inferiority design asks whether a new intervention can be shown not to be worse than a comparator by more than a prespecified amount. That amount is called the non-inferiority margin. The conclusion depends on the margin, the effect estimate, its uncertainty, and the planned analysis. A study can be designed to address non-inferiority without the registry record reporting whether the criterion was met. In this trial, non-inferiority is stated as the design for comparing overall cleansing success, but the margin, analysis details, and outcome results are not reported in the registry record.

How is the primary endpoint formed?

The endpoint is a binary participant-level classification: successful or unsuccessful overall bowel cleansing. The registry describes a blinded central reader using segmental Harefield Cleansing Scale scores to derive a final grade. Grades A and B were classified as successful, and grades C and D as unsuccessful. General statistical explanation: for a binary endpoint, an analysis typically compares the proportions or counts in the defined categories between groups. The exact measure and model used depend on the statistical plan. The registry record does not report the primary outcome counts or the analysis method, so no comparative effect should be inferred from the endpoint definition alone.

What does a confidence interval contribute?

General statistical explanation: a confidence interval gives a range of effect estimates compatible with the data under the assumptions of the analysis. Its width conveys precision: a wider interval indicates greater uncertainty, while a narrower interval indicates more precision. For a non-inferiority question, the interval is considered relative to the prespecified margin and the direction of the comparison. No confidence interval for the primary endpoint is reported in the registry record. As a result, the precision of the comparison and its relation to any non-inferiority margin cannot be evaluated.

Why do analysis populations matter?

The primary endpoint description says the overall number analyzed was based on an mFAS. It says this included randomized patients except for certain exclusions, including patients who were randomized but subsequently failed to meet entry criteria, and patients for whom a diary confirmed that the same patient did not receive any study treatment. The available wording ends mid-description, so the full definition and any further exclusions are not reported in the registry record. General statistical explanation: an analysis population determines which participants contribute to an estimate. Different populations can answer different questions, and in non-inferiority studies the chosen population and consistency across analyses can be especially important. The record does not report additional analysis-population results or how missing primary endpoint values were handled.

What do the planning assumptions mean?

The record describes planning illustrations based on an observed effect, with a two-sided significance level of 0.05, equal allocation between groups, and a normal approximation. It says the effect to detect is expressed as a stated fraction of the observed effect. General statistical explanation: such calculations illustrate the sample size associated with particular assumptions; they do not establish the trial’s observed power. They are not the trial’s own design justification unless the registry explicitly says so, and the record describes them as planning illustrations rather than the trial’s original design. No numerical illustration results, observed effect value, or original sample-size justification are reported in the registry record.

Why can over-dispersion matter?

General statistical explanation: over-dispersion occurs when variation in the data is greater than a model assumes. If a model does not account for that extra variation, uncertainty estimates can be too small and inferential results can be misleading. Whether over-dispersion is relevant depends on the outcome and analysis model. The primary endpoint is described as a binary classification, but the model and any assessment of its assumptions are not reported in the registry record. It would therefore be inappropriate to claim that over-dispersion was assessed or present in this study.

10. Multiplicity, Missing Data and Analysis Populations

The record lists six outcome measures and six analyses. It names four secondary outcomes: adenoma detection rate in the ascending colon, adenoma detection rate in the overall colon, polyp detection rate in the ascending colon, and polyp detection rate in the overall colon. The record does not give their results in the information available for this analysis. It also does not provide enough detail to describe the other listed outcome measures or the full analysis set.

General statistical explanation: when a study tests multiple outcomes or makes multiple comparisons, the chance of at least one apparently notable result can increase if each test is interpreted separately. A multiplicity plan may specify which outcome is primary, how secondary outcomes are interpreted, or whether statistical error rates are adjusted. Such a plan is not reported in the registry record. The record also does not report interim analyses or stopping rules, so neither their presence nor their absence should be inferred.

The mFAS description refers to exclusions for failure to meet entry criteria and for participants confirmed by diary not to have received any study treatment. The available description is truncated, and the full population definition is not reported in the registry record. The handling of missing endpoint values, the extent of missingness, and any sensitivity analyses are not reported either. These details matter because analysis-population membership and missing-data methods can affect the interpretation of a comparative estimate. Without them and without the primary outcome results, the robustness of the non-inferiority assessment cannot be evaluated.

11. Safety Results

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

Deaths

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: ovarian abscess (0.4%).

The registry reports serious adverse events for 241 participants at risk in the SP+MS group and 235 at risk in the NER1006 group. Serious adverse events affected 0 participants in SP+MS and 1 in NER1006. Deaths were 0 in each group. For other adverse events, 9 participants were affected among 241 at risk in SP+MS, and 32 among 235 at risk in NER1006. These are participant counts as recorded, not estimates of causation or treatment effect.

Ovarian abscess is listed among the top serious adverse event terms, with 0.4% reported. The record does not provide further context in the information available for this analysis, including the event’s group assignment or the basis for the percentage. It should not be used to infer a group-specific rate.

General statistical explanation: adverse-event counts are descriptive unless accompanied by appropriate definitions, observation periods, and a comparative analysis. Differences in counts alone do not establish that an intervention caused an event or altered risk. The registry information does not report event attribution, exposure duration, statistical comparisons, or details of how adverse events were collected. The counts therefore provide a limited description of reported events, not a complete safety assessment.

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

The record establishes that NCT02273141 was a randomized, single-masked, parallel-group phase III study comparing two day-before-only bowel-cleansing regimens in adults. It describes a primary endpoint based on successful overall cleansing, with grades A and B of the Harefield Cleansing Scale classified as successful. It also states that the primary comparison used a non-inferiority design. These registry entries describe the question and endpoint, not the answer to the question.

The primary outcome counts, the comparative estimate, its precision, and the non-inferiority margin are not reported in the registry record. Consequently, the available information does not show whether the groups differed, whether a non-inferiority criterion was met, or how uncertain any estimated difference would be. The trial’s completion status and enrollment figure do not replace those missing results.

The safety figures describe serious events, other adverse events, and deaths among the reported numbers at risk. They do not establish that an event was caused by a study regimen, and the record does not provide a comparative safety analysis. The ovarian abscess term is reported with 0.4%, but the information available does not establish its group assignment or provide enough context to interpret it further.

General statistical explanation: a trial result is best interpreted by considering the endpoint definition, analysis population, effect estimate, uncertainty, and prespecified decision rule together. For a non-inferiority question, the margin and the confidence interval are particularly important. Those components are not available for the primary comparison in the registry record. The appropriate conclusion is therefore limited: the record describes a comparative trial design and selected safety counts, while the comparative primary efficacy result cannot be assessed from the reported information.

13. Why This Trial Matters Statistically

This trial is statistically notable for its stated non-inferiority objective. Non-inferiority questions require more than a statement that two groups were compared: interpretation depends on the margin defining an acceptable loss, the estimated effect, its uncertainty, and the planned analysis. The registry record gives the design objective and describes the endpoint classification, but does not report the margin or the primary comparison results. This illustrates why a design label alone cannot establish a study’s conclusion.

The outcome construction also matters. The central assessment used segmental Harefield Cleansing Scale scores and converted the final grade into successful or unsuccessful cleansing. That classification defines what was counted, but interpretation still depends on the group-specific results and the population contributing to the analysis. The mFAS is named, although its full definition is not available in the record.

The record also lists adenoma and polyp detection outcomes in different colon locations. Multiple outcomes can raise questions about which results were primary and how secondary analyses should be interpreted. Although the primary outcome is named, the multiplicity strategy and results for the secondary outcomes are not reported in the registry record.

Finally, the registry provides safety counts but not a detailed comparative safety analysis. Separating descriptive counts from causal or inferential claims is essential. Taken together, these features make the record useful for identifying the trial question and several design choices, while its missing statistical results limit evaluation of the comparative evidence.

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 central limitation for interpretation is that the primary outcome comparison is not reported in the registry record. Group-specific success counts, an effect estimate, a confidence interval, a p-value, and the non-inferiority margin are not reported. The statistical method for the primary analysis is also not reported, so the stated design objective cannot be checked against a result or decision rule.

The population information is incomplete. The record refers to an mFAS and names some exclusions, but the available description is truncated. The number of participants included in the primary analysis and the handling of missing endpoint data are not reported. Although the record lists enrollment of 515, it does not explain how that figure relates to the brief summary’s expectation of approximately 484 randomized participants or its aim of a minimum of 220 in each of the 2 groups.

Important design and conduct details are not reported in the registry record, including the identity of the masked party, allocation procedures, the original sample-size justification, and the full statistical analysis plan. The record also does not report whether interim analyses were planned or conducted. Secondary outcome results and a multiplicity strategy are not available in the information used for this analysis.

The safety information is limited to counts and one listed serious adverse event term. Event attribution, observation duration, collection details, and comparative statistical analyses are not reported. These limitations constrain interpretation of both efficacy and safety; they do not establish that the missing methods or results were absent from trial documents outside the registry record.

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 a Sodium Picosulfate and Magnesium Salt Solution Using Day Before-Only Dosing Regimen in Adults. — NCT02273141.
• 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

NCT02273141 is listed as a completed, randomized, single-masked, parallel-group phase III study sponsored by Norgine. It compared NER1006 with SP+MS in adults requiring bowel cleansing before a procedure, using day-before-only split-dosing regimens. The registry lists enrollment of 515, a start date of 2014-11, and a primary completion date of 2015-08.

The primary endpoint was successful overall bowel cleansing, assessed by a blinded central reader using the Harefield Cleansing Scale; grades A and B were classified as successful. The primary comparison was described as non-inferiority. The registry record does not report the primary outcome results, non-inferiority margin, or analysis details needed to evaluate that comparison.

Reported safety counts include serious adverse events, other adverse events, and deaths by group. The record also lists adenoma and polyp detection outcomes. Full population definitions, missing-data methods, multiplicity handling, and further statistical-plan details are not reported in the registry record.