Study to Assess the Efficacy and Safety of NTRA-2112 on Intestinal Malabsorption in Preterm Infants: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Study to Assess the Efficacy and Safety of NTRA-2112 on Intestinal Malabsorption in Preterm Infants (NCT02510560), a randomized phase 3 study. The primary outcome is Numbers of Days to Achieve Complete Enteral Feeding.

2. Clinical Question

The trial was registered as randomized, multicenter, double-blind, three-arm, parallel-group, and placebo controlled. Its primary endpoint concerns the time until a feeding threshold was reached and sustained, rather than a single feeding measurement. Lower numbers of days indicate an earlier recorded achievement of that threshold. The registry record also lists days to hospital discharge or readiness for discharge as a secondary outcome, which addresses a related but distinct milestone.

The posted primary outcome summaries include means and standard deviations for each group, and the sponsor’s reported comparisons use a stratified Van Elteren test. Recalculated comparisons based on the posted group summaries estimate unadjusted mean differences. These approaches do not produce identical summaries, so the reported sponsor analysis and the recalculation should be read as different statistical views of the same comparison, not as interchangeable results.

3. Trial Design

The registry identifies this as a phase 3 study sponsored by Elgan Pharma Ltd. It was randomized, multicenter, double-blind, parallel-group, and placebo controlled, with three arms: NTRA-2112 A, NTRA-2112 B, and placebo. The masking field specifies quadruple masking. The planned enrollment recorded in the registry was 300. That figure is the registered enrollment, not a statement of how many participants contributed to every posted outcome analysis.

The intervention descriptions specify oral administration with daily feed for 28 days or until discharge from hospital. The two active groups are described as different doses, but the dose quantities are not reported in the registry record. The record gives a start date of 2016-10-09 and a primary completion date of 2018-04-25. The study status is terminated; the reason for termination is not reported in the registry record.

The primary outcome was the number of days to achieve complete enteral feeding, with a timeframe of 28 days or discharge from hospital. Posted primary outcome group sizes are 84 for NTRA-2112 A, 78 for NTRA-2112 B, and 76 for placebo. Outcome-specific denominators can differ from the registered enrollment, and the record does not explain all reasons for the observed group-size differences or specify how missing primary outcome data were handled.

The registry does not report the original sample-size justification, the planned allocation ratio, or the full protocol for the statistical analyses. It also does not report whether interim analyses were conducted. Those omissions limit what can be concluded about the study’s original design assumptions and planned decision rules. The estimates and planning illustrations associated with the posted results therefore should not be mistaken for a reconstruction of the trial’s original design.

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:

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: Due to early study termination by the Sponsor, only 300 of the 450 intended subjects were enrolled.

6. Primary Endpoint

The registry lists the primary outcome as Numbers of Days to Achieve Complete Enteral Feeding, measured over 28 days or discharge from hospital.

The primary endpoint is the number of days to achieve complete enteral feeding. The registry defines this as the number of days until the first day on which enteral feeding reaches at least 150 ml/kg/day and remains at that level for at least 3 consecutive days. The sustained-threshold definition makes the endpoint more specific than simply recording the first day at which a feeding level is reached: the qualifying level must continue for the stated period.

This is a continuous time measure, summarized in the registry using a mean and standard deviation. It describes the average observed time in each group, while the standard deviation describes the spread of participant-level times around that average. A smaller mean represents fewer days to the defined feeding milestone. The endpoint is used to compare the timing of that milestone between each active group and placebo; by itself, it does not describe other aspects of feeding, discharge, or longer-term health.

The outcome timeframe is 28 days or discharge from hospital. The registry does not provide a detailed rule for observations after discharge, handling of participants who did not reach the threshold within the timeframe, or treatment of missing measurements. These details matter to interpretation because they determine how the recorded number of days is defined for every participant included in the analysis. The registry record also does not report a clinically important difference for this endpoint, so the statistical estimates alone do not establish what size of difference would matter clinically.

7. Results Posted in the Registry

• NTRA-2112 A: mean 9.30 versus 10.30 on control; difference -1.00 (95% CI -2.54 to 0.54), standardized effect d = -0.20; z-test p = 0.203.
• NTRA-2112 B: mean 10.00 versus 10.30 on control; difference -0.30 (95% CI -2.07 to 1.47), standardized effect d = -0.05; z-test p = 0.740.

8. Secondary Efficacy Endpoints

The registry also posts results for secondary outcomes. For each outcome below, the endpoint type, the test applied to the posted summary statistics, the result and its interpretation are given in turn. Secondary endpoints are usually not adjusted for multiple testing, so they support rather than confirm the primary finding.

Number of Days to Achieve Discharge From Hospital or Readiness to Discharge

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • NTRA-2112 A: mean 36.40 versus 36.00 on control; difference 0.40 (95% CI -4.30 to 5.10), standardized effect d = 0.03; z-test p = 0.868.
  • NTRA-2112 B: mean 33.80 versus 36.00 on control; difference -2.20 (95% CI -6.69 to 2.29), standardized effect d = -0.15; z-test p = 0.336.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between NTRA-2112 A and the control. The interval gives the range of effects that remain compatible with the data.
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between NTRA-2112 B and the control. The interval gives the range of effects that remain compatible with the data.

The registry lists one secondary outcome: days to hospital discharge or readiness for discharge. Its group means are close in the posted results, and the recalculated active-versus-placebo mean differences are small relative to the uncertainty in those estimates. The sponsor’s stratified comparisons are also reported for both active groups. Taken together, the secondary endpoint does not present a clear pattern of a precise difference across the active groups and placebo.

This endpoint concerns a later or related clinical milestone than the primary feeding endpoint, but it is not the same measure. A participant’s time to the feeding threshold and time to discharge can be related without being interchangeable. The secondary results therefore provide additional context, not a replacement for the primary outcome. Nor do they establish that a difference in feeding time necessarily leads to a difference in discharge timing.

Secondary findings generally carry less evidential weight when many outcomes or comparisons are examined without an adjustment for multiplicity. Testing multiple hypotheses increases the chance that at least one result appears noteworthy by chance. The registry record does not report a multiplicity adjustment or the full hierarchy of planned outcomes and tests. The reported secondary p-values should consequently be treated as unadjusted evidence unless the record supplies further information, rather than as independent confirmation of the primary result.

The record reports a single secondary outcome title and does not describe whether additional secondary measures were planned but not posted. The results should be interpreted within that limitation. Their main role is to describe the observed pattern for the discharge-related measure, while the uncertainty and incomplete reporting of analysis details caution against strong conclusions from the secondary comparisons.

Secondary outcomes registered for this trial, for reference (only those above were recalculated):

• Number of Days to Achieve Discharge From Hospital or Readiness to Discharge

9. Statistical Interpretation

10. Statistical Methods Explained

The registry presents two types of comparison for each primary active-versus-placebo contrast. The sponsor-reported results use a stratified Van Elteren test. Separately, recalculated results use the posted group means and standard deviations to estimate an unadjusted difference in means and its confidence interval. These methods emphasize different features of the data, which helps explain why their p-values are not the same.

What does the stratified Van Elteren test do?

In general, the Van Elteren test is a stratified, rank-based comparison. A rank-based approach uses the ordering of observations rather than relying only on a comparison of group averages. Stratification means that comparisons are conducted within defined strata and then combined. This can account for a stratification structure specified by the study, but the particular stratification factors and implementation are not reported in the registry record. The record identifies the method and provides a p-value for each active group versus placebo, but it does not provide a treatment-effect estimate or confidence interval from this test.

A p-value describes how compatible the observed data are with a specified null comparison under the assumptions of the test. It is not the probability that the null hypothesis is true, and it does not measure the size or clinical importance of an effect. Because the registry does not report the full analysis plan or all test details, the p-values should be interpreted as the sponsor-reported results rather than as a complete account of the inferential procedure.

What does the recalculated mean difference represent?

The recalculated estimate subtracts the placebo mean from the active-group mean. A negative difference therefore means the posted active-group mean was lower, or involved fewer days, than the posted placebo mean. These are simple unadjusted comparisons calculated from the summary statistics. They do not incorporate the stratification used by the sponsor’s reported test, nor do they adjust for other factors. The registry record identifies the recalculations as unadjusted, and the sponsor’s own analysis is the primary reported analysis for its test-based comparisons.

The standard deviation describes how spread out individual observations are within a group. A pooled standard deviation combines information about spread across the two groups for the recalculation. The standardized effect estimate expresses the mean difference relative to that pooled spread. This can help describe the size of a difference on a scale that accounts for outcome variability, but it does not provide a clinical interpretation on its own. In particular, a standardized effect does not tell readers what difference would be meaningful to infants or families.

Why can two analyses give different p-values?

The stratified Van Elteren test is rank based and stratified, while the recalculated comparison is an unadjusted comparison of means. The tests can therefore use the data differently and need not return the same p-value. This is not, by itself, evidence that one result is erroneous. The sponsor-reported p-values should be kept distinct from the recalculated p-values and confidence intervals rather than blended into one result. The registry record does not provide enough detail to reproduce the sponsor’s stratified analyses independently.

The record reports no discrepancy flag for the recalculations. Even so, a summary-statistic recalculation is not a substitute for an individual-participant analysis or the full sponsor analysis. It cannot reproduce participant-level handling, any stratification, or decisions about missing observations that are not described in the registry record.

Why does outcome variability matter?

General statistical explanation: variability affects how precisely a group mean or a difference in means can be estimated. When participant outcomes vary substantially within groups, the observed means are less informative about the underlying group averages than they would be with less variability, all else being equal. The standard deviations posted for the primary outcome show that days to the feeding milestone varied across participants. A confidence interval combines the estimated difference with its uncertainty, so wider intervals indicate less precision.

Over-dispersion is a concern in settings where a model assumes more uniform variation than the data actually contain. In general, underestimating variability can make standard errors too small and confidence intervals too narrow. The primary endpoint is analyzed as a continuous mean outcome, and the registry record does not report an over-dispersion assessment or a model requiring a count-data dispersion assumption. It would therefore be inappropriate to claim that over-dispersion was assessed or affected these results.

Finally, the registry record does not report whether the analysis was intention-to-treat, per-protocol, or based on another population definition. It also does not state how missing values were handled, whether the analyses were adjusted for multiple comparisons, or whether any interim analyses occurred. These methodological details can affect the interpretation of estimates and p-values, and their absence should remain visible when assessing the reported findings.

11. Confidence Intervals and Precision

The recalculated confidence intervals express uncertainty around the unadjusted mean differences. For NTRA-2112 A, the estimate is -1.0 day, and the interval extends from -2.54 to 0.540 days. For NTRA-2112 B, the estimate is -0.3 day, and the interval extends from -2.072 to 1.472 days. Both intervals include zero, so the posted summary statistics are compatible with no mean difference as well as with differences in either direction.

The intervals also show that the estimated differences are not highly precise. For NTRA-2112 A, the interval includes values indicating fewer days in the active group and values indicating more days. The same is true for NTRA-2112 B. The point estimates alone should not be read as exact effects: each is an estimate from the observed group summaries, and the interval conveys the uncertainty around it.

These confidence intervals are for the recalculated unadjusted mean comparisons, not for the sponsor’s stratified Van Elteren tests. The registry gives p-values for those sponsor tests but does not report associated effect estimates or confidence intervals. Accordingly, the intervals cannot be used to describe the uncertainty of the sponsor’s test-based effect estimate.

A confidence interval does not give the probability that the true effect lies inside the specific interval. In general, it is a range produced by a method that, under its assumptions, would cover the target quantity at its stated confidence level over repeated use. The confidence level for these recalculated intervals is not stated in the registry record. The registry also does not report a clinically important difference for the primary endpoint, so the intervals cannot by themselves distinguish clinically important from unimportant values.

12. Planning a Similar Trial: Sample Size

This is a planning illustration, not a re-evaluation of the original trial. It asks: if a new study wanted to detect a difference like the one observed, or a smaller one, how large would it need to be? It is deliberately not “observed power” of the finished trial, which is not a meaningful quantity.

The planning figures are participants per arm, not total events. They are illustrations based on the observed effect, not the trial’s original sample-size design. The listed assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. Each planning scenario uses the stated fraction of the observed effect as the effect to detect. The original trial’s own sample-size assumptions and justification are not reported in the registry record.

The 80% power column gives the number of participants per arm indicated by the planning calculation for an 80% chance of detecting the specified effect under those assumptions. The 90% power column gives the corresponding number per arm for a 90% chance. Power is a property of a planned design under assumed conditions; it does not describe the probability that a particular result is correct or the probability that a treatment effect exists.

The scenarios that plan for 100% of the observed effect use the observed estimate as the target effect. Scenarios planning for 75% or 50% of that effect target smaller differences. Smaller effects are harder to distinguish from random variation, so they require more participants per arm to attain the same planned power. The displayed values can become very large when the observed effect is small relative to the outcome variability; they should be read as sensitivity illustrations, not as recommended enrollment targets for a future study.

These figures are not observed power. They do not calculate the probability that the completed trial detected an effect after seeing its results. They also do not account for design details or analysis choices not included in the stated planning assumptions, such as the sponsor’s stratified test, because the illustration is based on the stated normal-approximation setup.

13. How the Sample Size Is Derived

Power is the probability that a study of a given size rejects the null hypothesis when a specific true effect exists. It depends on four things: the effect to detect, the variability of the outcome, the significance level (here a two-sided α of 0.05, so z_1−α/2 = 1.960) and the desired power (z_1−β = 0.842 for 80% and 1.282 for 90%).

Formula

n is the number of participants in each arm, Δ is the difference in means to detect and σ is the common standard deviation.

Worked calculation for this trial

1. Observed difference Δ = -1.000; pooled standard deviation σ = 4.950.
2. n = 2 × (1.96 + 0.842)² × 4.950² / -1.000² = 384.6, rounded up to 385 participants per arm for 80% power.

The smaller-effect rows in the table above repeat the same calculation with the effect multiplied by 0.75 and 0.5 (for ratios, applied to the logarithm of the ratio).

R code

alpha <- 0.05
z_a   <- qnorm(1 - alpha / 2)          # two-sided
delta <- -1                      # observed difference in means
sigma <- 4.9497770695229                     # pooled standard deviation
n_per_arm <- function(power, frac = 1) {
  ceiling(round(2 * (z_a + qnorm(power))^2 * sigma^2 / (delta * frac)^2, 6))
}
for (f in c(1, 0.75, 0.5))
  cat(sprintf("%3.0f%% of observed effect: n per arm = %s (80%% power), %s (90%% power)\n", 100 * f,
              format(n_per_arm(0.80, f), big.mark = ","), format(n_per_arm(0.90, f), big.mark = ",")))

# Check against R's built-in function (t-based, so very slightly larger)
cat("power.t.test:", round(power.t.test(delta = delta, sd = sigma, power = 0.80)$n, 1), "\n")

# Simulation: exact two-sample t-test using simulated means and variances
set.seed(2510560)
n    <- n_per_arm(0.80)
reps <- 20000
m_diff <- rnorm(reps, delta, sigma * sqrt(2 / n))             # difference in sample means
s2     <- sigma^2 * rchisq(reps, 2 * (n - 1)) / (2 * (n - 1))   # pooled sample variance
tstat  <- m_diff / sqrt(s2 * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(tstat) > qt(0.975, 2 * (n - 1))), reps))

Output from running the code

100% of observed effect: n per arm = 385 (80% power), 515 (90% power)
 75% of observed effect: n per arm = 684 (80% power), 916 (90% power)
 50% of observed effect: n per arm = 1,539 (80% power), 2,060 (90% power)
power.t.test: 385.6 
Simulated power at n = 385 per arm: 0.804 (20000 replicates)

The simulation draws many sets of group means and variances at the planned sample size and counts how often the two-sample t-test rejects the null. It should land close to the target power; at very small required sample sizes it can fall below it, because the normal approximation is rough there.

14. Analyses Reported by the Sponsor

The sponsor’s primary-outcome comparisons are reported as stratified Van Elteren tests. The reported p-values are 0.115 for NTRA-2112 A versus placebo and 0.243 for NTRA-2112 B versus placebo. The registry does not provide sponsor-reported effect estimates or confidence intervals for these tests.

The recalculated comparisons use the posted means and standard deviations to estimate unadjusted mean differences. They give estimates of -1.0 day for NTRA-2112 A versus placebo and -0.3 day for NTRA-2112 B versus placebo, with unadjusted p-values of 0.203 and 0.74, respectively. The recalculation also gives confidence intervals for these mean differences. Because the sponsor test is stratified and rank based while the recalculation compares means without stratification, the differing p-values are not direct substitutes for one another.

The discrepancy flag is false, but the recalculations remain simple checks from posted summary statistics rather than reproductions of the sponsor’s analysis. The registry does not report enough detail to reconstruct the sponsor’s strata or reproduce its test. The sponsor’s results should therefore be read as the reported trial analyses, while the recalculated estimates provide a separate view of the unadjusted mean differences and their precision.

15. Multiplicity, Missing Data and Analysis Populations

The study compares two active groups with placebo on the primary endpoint, and it also reports a secondary endpoint with active-versus-placebo analyses. Multiple comparisons raise a statistical issue: when several hypotheses are tested, the chance of at least one apparently unusual result can increase even if none of the underlying effects is real. Methods such as a prespecified testing hierarchy or an adjustment to the significance threshold can address this issue, but the registry record does not report whether such a plan was used.

The registry reports the sponsor’s p-values and identifies the tests as superiority analyses. It does not report a complete statistical analysis plan, a multiplicity procedure, or a prespecified decision threshold for interpreting the family of comparisons. The recalculated p-values are explicitly unadjusted. They should not be treated as adjusted evidence across the two doses and endpoints.

Important analysis-population details are also not reported in the registry record. In particular, the record does not state whether the sponsor used an intention-to-treat population, a per-protocol population, or another defined population for each analysis. The posted primary outcome group sizes differ across groups, and the secondary outcome has its own group sizes; the record does not explain the participant flow or why some outcome denominators differ.

The registry record does not describe the extent or pattern of missing outcome data, the method used to handle missing observations, or whether any sensitivity analyses were performed. Those details matter because analysis results can depend on which participants contribute data and how unavailable outcomes are treated. The record also does not report whether interim analyses were conducted or whether stopping rules were used. Without those details, it is not possible to assess how they might have affected the analysis or its interpretation.

16. 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 5% reporting threshold.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: necrotising enterocolitis neonatal (8.2%), sepsis neonatal (5.2%), patent ductus arteriosus (3.4%), necrotising colitis (3.1%), neonatal pneumonia (2.1%).

The posted safety results list serious adverse events and other adverse events by group, with counts of participants at risk and affected. For serious adverse events, the record gives 15 affected among 108 at risk in NTRA-2112 A, 10 among 88 in NTRA-2112 B, and 19 among 97 in placebo. The listed death counts are 5, 1, and 4, respectively. The safety denominators differ from the primary outcome analysis group sizes; the registry does not explain the relationship between these populations.

The most frequently listed serious-event terms overall include necrotising enterocolitis neonatal at 8.2%, sepsis neonatal at 5.2%, patent ductus arteriosus at 3.4%, necrotising colitis at 3.1%, neonatal pneumonia at 2.1%, and intestinal perforation at 1.1%. The registry does not provide arm-specific counts for each of these terms in the posted summary, so the terms and percentages should not be interpreted as comparative risks between groups.

These summaries are descriptive. The registry does not provide enough detail about event timing, severity definitions, attribution, or statistical comparisons to establish whether group differences are meaningful or related to treatment. The counts should be read with those limits in mind.

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

The posted primary results describe average time to the defined enteral-feeding milestone in each group. Both recalculated mean differences are negative, indicating lower observed means in the active groups than in placebo. However, each confidence interval includes zero and extends to values in the opposite direction. The estimates therefore do not precisely establish a difference in mean days for either active comparison.

The sponsor’s reported stratified test p-values are 0.115 and 0.243. Those results should be understood as analyses of the posted trial data using the sponsor-identified method, not as probabilities that the treatments work or fail. The record does not report sponsor estimates or confidence intervals for those tests, and it does not report a clinically important threshold for the primary outcome. Statistical evidence and clinical importance are different questions.

These results do not establish that the groups are identical. A lack of precise evidence for a difference is not proof of equivalence or non-inferiority; the registry does not report an equivalence or non-inferiority design. Likewise, the point estimates alone do not establish that either active dose produces a meaningful change. The uncertainty shown by the recalculated intervals is important when interpreting both the direction and magnitude of the observed differences.

The study status is terminated, but the reason is not reported in the registry record. Termination alone does not explain the outcome findings or indicate why the study ended. The record also does not explain the differences between registered enrollment and outcome-specific group sizes, define the analysis populations, or describe missing-data handling. Conclusions should remain limited to the posted summaries and reported tests, without inferring unreported design or conduct details.

18. Why This Trial Matters Statistically

This trial illustrates why an effect estimate, its uncertainty, and a test result should be considered together. A p-value alone does not describe the size of a difference, while a mean difference alone can give an incomplete impression if its interval is wide. For the primary endpoint, the recalculated mean differences favor fewer observed days in the active groups, but their intervals include zero and values in both directions. That combination makes precision central to interpretation.

The record also makes visible the distinction between a sponsor-reported stratified rank-based test and a simple unadjusted comparison of means. These methods may use the data differently, so their p-values need not match. Keeping the analyses separate helps avoid treating a recalculation from summary statistics as though it were the sponsor’s original analysis.

The three-arm design makes the interpretation of multiple comparisons relevant. Without a reported multiplicity plan, nominal p-values do not by themselves summarize the evidence across all doses and endpoints. The secondary discharge-related outcome adds useful context, but it does not replace the primary feeding outcome or independently confirm it.

Finally, reporting gaps matter to statistical interpretation. The registry does not give the original sample-size justification, analysis populations, missing-data procedures, or reason for termination. These omissions limit the ability to assess design assumptions and the robustness of the posted analyses. Clear distinctions between what the record reports and what remains unknown are essential when drawing conclusions from clinical trial summaries.

19. 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.

Several limitations specific to this trial affect interpretation. The registry record identifies the study as terminated but does not report the reason. It gives a registered enrollment of 300, while the primary and secondary outcome summaries have their own group sizes; participant flow and reasons for differences in outcome denominators are not described. These figures should not be assumed to represent identical analysis populations.

The registry does not report the original sample-size justification, allocation ratio, analysis-population definitions, missing-data methods, or the full analysis plan. It also does not specify the stratification factors used in the sponsor’s Van Elteren tests. Without those details, the sponsor analysis cannot be independently reproduced from the registry record, and the recalculated unadjusted comparisons should not be mistaken for a complete reanalysis.

The record does not report a clinically important difference for the primary endpoint or a multiplicity adjustment across doses and endpoints. Consequently, the estimates cannot establish the clinical importance of a difference, and the reported unadjusted p-values should be interpreted cautiously when considering multiple comparisons. The registry also does not provide sponsor effect estimates and confidence intervals for its stratified tests.

Safety summaries are limited as well. The record gives group counts and overall serious-event terms but does not report arm-specific counts for each listed event term, timing, attribution, or comparative safety analyses in this summary. The registry status and posted summaries do not support inferences about why the trial ended, how missing observations affected results, or the causes of individual adverse events.

20. Related Tutorials

21. Related Statistical Calculators

22. Sources

• ClinicalTrials.gov: Study to Assess the Efficacy and Safety of NTRA-2112 on Intestinal Malabsorption in Preterm Infants — NCT02510560.
• Registry record last updated 2025-08-19; status last verified 2025-07.
• Results first posted 2025-06-06.
• 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.

23. Record Summary

NCT02510560 is a randomized, multicenter, double-blind, three-arm, parallel-group, placebo-controlled phase 3 study sponsored by Elgan Pharma Ltd. It evaluated two NTRA-2112 dose groups against placebo in preterm infants with intestinal malabsorption. The registered enrollment was 300, and the study status is terminated.

The primary endpoint was days to achieve complete enteral feeding, defined as reaching at least 150 ml/kg/day and sustaining that level for at least 3 consecutive days. The sponsor reported stratified Van Elteren tests; recalculated unadjusted mean differences were -1.0 day for NTRA-2112 A versus placebo and -0.3 day for NTRA-2112 B versus placebo. Their confidence intervals include zero. The registry does not report the reason for termination, the original sample-size justification, analysis-population definitions, or missing-data methods.