Efficacy and Safety After Multiple Doses of TNP-2198 Capsules, Rabeprazole Sodium Enteric-coated Tablets and Amoxicillin Capsules in Helicobacter Pylori Infected-positive Participants: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Efficacy and Safety After Multiple Doses of TNP-2198 Capsules, Rabeprazole Sodium Enteric-coated Tablets and Amoxicillin Capsules in Helicobacter Pylori Infected-positive Participants (NCT06076694), a randomized phase 2 study. The primary outcome is The Eradication Rate of Helicobacter Pylori Infection.

2. Clinical Question

3. Trial Design

The registry record describes a randomized, open-label, parallel-group study at a single center. It is registered as Phase 2; the official title describes the study as Phase Ic/IIb. The study status is completed, and the recorded enrollment is 80 participants. The study start date is 2022-06-26, and primary completion is recorded as 2022-09-20.

Participants were assigned to Group A, Group B, Group C, Group D, or a control group. The four active regimens differed in TNP-2198 dose, the listed use of amoxicillin, dosing frequency, or treatment duration. The control regimen listed rabeprazole and amoxicillin. The arm descriptions specify treatment for 14 days in Groups A, B, and C, and for 7 days in Group D; a treatment duration for the control group is not reported in the registry record.

Masking is listed as none, so the study was open-label. The registry record identifies a primary endpoint, the eradication rate of H. pylori, measured as participants with a negative urea breath test. It specifies different assessment windows relative to the first dose: Day 44~Day 50 for Groups A, B, and C and the control group, and Day 37~Day 43 for Group D. The mITT population description separately refers to a test performed on Day 28 to 34 after the last dose. The registry record does not explain how these timing descriptions relate to one another.

The record does not report the original sample-size justification, the intended statistical analysis plan, or further details about randomization procedures. These omissions limit how fully the design and analysis choices can be evaluated.

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

Analysis population for the primary outcome, as defined in the registry: Modified Intent-to-Treat Analysis Set (mITT): Refers to all randomized participants who have 14C UBT performed on Day 28 to 34 after the last dose of the study.

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.

6. Primary Endpoint

The registry lists the primary outcome as The Eradication Rate of Helicobacter Pylori Infection, measured over Group A, B,C,control group: Urea breath test is assessed Day 44~Day 50 after the first dose; Group D: Urea breath test is assessed Day 37~ Day 43 after the first dose.

The primary endpoint is the count of participants whose urea breath test was negative. The registry record defines a negative test as H. pylori eradication. The outcome is therefore binary at the participant level: each assessed participant either had a negative test or did not. The posted results give the number with the event and the number in each group.

A urea breath test is used in this study as the test-based criterion for the primary outcome. The registry record places the assessment after treatment, with an assessment window of Day 44~Day 50 after the first dose for Groups A, B, and C and the control group, and Day 37~Day 43 for Group D. The mITT definition also specifies a test on Day 28 to 34 after the last dose. The record does not report additional endpoint validation details or explain the relationship between those timing descriptions.

For a binary outcome, a group’s event count is interpreted alongside the number of participants assessed. A count alone does not describe the uncertainty in the observed proportion or establish that groups differ. The comparisons therefore also report estimated risk differences and confidence intervals. The endpoint captures the specified test result at the stated assessment; it does not, by itself, describe other clinical outcomes or longer-term results, which are not reported in the registry record.

7. Results Posted in the Registry

• Group A: 94.7% (18/19) versus 80.0% (16/20) on control; risk difference 14.7 percentage points (95% CI -5.5 to 34.9), risk ratio 1.18 (0.93–1.51); unadjusted two-proportion z-test p = 0.169.
• Group B: 89.5% (17/19) versus 80.0% (16/20) on control; risk difference 9.5 percentage points (95% CI -12.8 to 31.8), risk ratio 1.12 (0.86–1.46); unadjusted two-proportion z-test p = 0.412.
• Group C: 50.0% (5/10) versus 80.0% (16/20) on control; risk difference -30.0 percentage points (95% CI -65.6 to 5.6), risk ratio 0.62 (0.32–1.21); unadjusted two-proportion z-test p = 0.091.
• Group D: 100.0% (10/10) versus 80.0% (16/20) on control; risk difference 20.0 percentage points (95% CI 2.5 to 37.5), risk ratio 1.25 (1.00–1.56); unadjusted two-proportion z-test p = 0.129.

8. Statistical Interpretation

9. Statistical Methods Explained

What does the event count represent?

The primary outcome is binary for each participant: the urea breath test was either negative or not negative. The posted count records participants meeting the endpoint definition. Its denominator is the number shown for that group in the primary outcome results. For example, the record reports 18 participants with the event in Group A, with 19 in that group’s outcome denominator. The count should be read together with its denominator; it is not a rate unless expressed relative to that denominator.

General statistical explanation: a binary outcome is often summarized as a proportion, and a comparison can describe the difference between two such proportions. The registry record reports risk differences, which express the group comparison on an absolute scale. A positive estimate means the observed proportion in the named group is higher than in control; a negative estimate means it is lower. The estimate is descriptive of the analyzed data and is subject to sampling uncertainty.

How should a risk difference be read?

The risk difference for Group A versus control is 0.147; for Group B it is 0.095; for Group C it is -0.3; and for Group D it is 0.2. These values are reported as proportions, not as percentage-point values. They summarize the observed contrast between each group and control. They do not adjust for other characteristics, and the registry record does not describe an adjusted model.

The record also includes relative risks for the reported comparisons, and an odds ratio for Groups A, B, and C. These are alternative ways to express a binary-outcome contrast. A risk difference expresses an absolute contrast; a relative risk compares proportions as a ratio; an odds ratio compares odds. Each measure has its own interpretation, and values on different scales should not be compared as if they were interchangeable. The record does not report an odds ratio for Group D.

What does a confidence interval add?

General statistical explanation: a confidence interval describes the range of values compatible with the observed data under the interval’s method and assumptions. A wider interval signals less precision than a narrower one. An interval that spans zero for a risk difference includes values corresponding to no difference as well as values in either direction. The registry record does not state the confidence level or method used for these intervals, so those details should not be presumed.

The reported intervals are -0.055 to 0.349 for Group A, -0.128 to 0.318 for Group B, -0.656 to 0.056 for Group C, and 0.025 to 0.375 for Group D. Their breadth reflects substantial uncertainty in the estimated differences, especially in the groups with fewer outcome observations. The interval for Group D does not span zero, but its reported unadjusted p-value is 0.129. Because the interval method and test method are not reported, this apparent difference should be flagged rather than reconciled by assumption.

What does an unadjusted p-value tell the reader?

General statistical explanation: a p-value describes how unusual data at least as incompatible with a specified null hypothesis would be under that hypothesis and the test’s assumptions. It is not the probability that the null hypothesis is true, and it does not measure the size or clinical importance of a difference. The registry reports unadjusted p-values of 0.169 for Group A, 0.412 for Group B, 0.091 for Group C, and 0.129 for Group D. The record does not identify the testing procedure or report adjusted p-values.

Because several regimens are compared with control, multiplicity is relevant. General statistical explanation: when many hypotheses are tested, the chance of at least one apparently unusual result can increase if each test is interpreted independently. Procedures for controlling that issue need to be specified in an analysis plan. No such procedure is reported in the registry record, so the posted p-values should not be interpreted as multiplicity-adjusted evidence.

Which analysis population is described?

The primary outcome population is called the modified Intent-to-Treat Analysis Set. It is defined as all randomized participants who had 14C UBT performed on Day 28 to 34 after the last dose. This definition makes the availability of the specified test part of the analysis population. The registry record does not report how many randomized participants lacked a test, how those participants were treated analytically, or whether another analysis population was used as a sensitivity check.

General statistical explanation: missing endpoint data can affect a comparison if the probability of having an observed result differs between groups or is related to the outcome. Researchers may use different prespecified approaches to handle missing outcomes, but the choice and its assumptions matter. The record does not report a missing-data method, so no assumption about the unobserved test results is justified.

The posted event counts and denominators should be distinguished from the safety group denominators. For example, the primary endpoint denominators are 19 for Group A and 19 for Group B, while the safety groups list 20 at risk in each. The registry record does not explain these differences. Without participant-flow details, the reasons for differing denominators cannot be determined.

10. Confidence Intervals and Precision

The group comparisons are estimated with limited precision. The reported risk-difference intervals are broad, and each interval spans a meaningful range of possible contrasts. For Group A, the interval runs from -0.055 to 0.349; for Group B, from -0.128 to 0.318; for Group C, from -0.656 to 0.056. Those intervals include zero, so the reported estimates do not rule out no difference under the interval method. The Group D interval, 0.025 to 0.375, lies above zero, but the corresponding unadjusted p-value is 0.129. The confidence-interval level and method are not reported, and the test method is also not reported, so the difference between these two summaries cannot be resolved from the registry record.

General statistical explanation: precision concerns how narrowly an estimate is localized by the data and analysis assumptions. It is distinct from the estimated direction or size of an effect. Smaller groups and fewer observed events generally provide less information for estimating a binary outcome contrast, which can result in wider intervals. This is relevant because the outcome denominators vary across groups, and Groups C and D have smaller denominators than the other groups.

The reported comparisons should therefore be read as uncertain estimates rather than exact differences. The record does not report the confidence level, the interval calculation method, or a detailed statistical analysis plan. Those omissions limit interpretation of interval coverage and the relationship between intervals and p-values. More precise estimates would require additional information or data, but the registry record does not provide a basis for predicting what a larger study would find.

11. 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 participants and not total events. They are available for the comparisons of Groups A, B, and C with control; no planning figures are reported for Group D. The rows consider planning for 100% of the observed effect, 75% of the observed effect, and 50% of the observed effect. For example, planning for 75% of the observed effect in the Group A comparison gives 158 participants per arm for 80% power and 211 participants per arm for 90% power.

The stated planning assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. The effect to detect is set to the stated fraction of the observed effect. The sample-size assumptions for the trial’s original design are not reported in the registry record; these figures are a separate planning illustration computed from observed effects.

The 80% power column gives the estimated participants per arm under those assumptions for a design with 80% power to detect the chosen effect. The 90% power column gives the corresponding per-arm planning figure for a design with 90% power. The curve visualizes how the planning requirement changes with the assumed effect size. Smaller effects require more participants to detect under the same assumptions, as reflected by the larger planning figures for smaller fractions of the observed effect. These are forward-looking planning illustrations, not observed power.

12. 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, p₀ and p₁ are the control and treatment proportions, and p̄ is their average.

Worked calculation for this trial

1. Control proportion p₀ = 0.800; treatment proportion p₁ = 0.947; average p̄ = 0.874.
2. First term: z_1−α/2 × √[2p̄(1−p̄)] = 1.96 × 0.4698 = 0.9208.
3. Second term: z_1−β × √[p₀(1−p₀) + p₁(1−p₁)] = 0.842 × 0.4581 = 0.3856.
4. n = (0.9208 + 0.3856)² / (0.1474)² = 78.6, rounded up to 79 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
p0 <- 0.8                          # control proportion
p1 <- 0.947368421052632                          # treatment proportion
n_per_arm <- function(power, frac = 1) {
  q1 <- p0 + (p1 - p0) * frac               # smaller effect = fraction of the observed difference
  pbar <- (p0 + q1) / 2
  z_b <- qnorm(power)
  ceiling(round((z_a * sqrt(2 * pbar * (1 - pbar)) + z_b * sqrt(p0 * (1 - p0) + q1 * (1 - q1)))^2 / (q1 - p0)^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 (unrounded n per arm)
cat("power.prop.test:", round(power.prop.test(p1 = p0, p2 = p1, power = 0.80)$n, 1), "\n")

# Simulation: how often does the z-test reject at the 80%-power sample size?
set.seed(6076694)
n    <- n_per_arm(0.80)
reps <- 20000
x0 <- rbinom(reps, n, p0); x1 <- rbinom(reps, n, p1)
ph <- (x0 + x1) / (2 * n)
z  <- ((x1 - x0) / n) / sqrt(ph * (1 - ph) * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(z) > z_a, na.rm = TRUE), reps))

Output from running the code

100% of observed effect: n per arm = 79 (80% power), 105 (90% power)
 75% of observed effect: n per arm = 158 (80% power), 211 (90% power)
 50% of observed effect: n per arm = 394 (80% power), 527 (90% power)
power.prop.test: 78.6 
Simulated power at n = 79 per arm: 0.827 (20000 replicates)

The simulation draws many pairs of event counts at the planned sample size and counts how often the two-proportion z-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.

13. Multiplicity, Missing Data and Analysis Populations

The registry record reports comparisons of Groups A, B, C, and D with the control group. Each comparison has an unadjusted p-value. It does not report a multiplicity correction, a hierarchy of primary comparisons, or a rule for deciding which comparison should be treated as the principal test. When several comparisons are examined, the interpretation of unadjusted p-values differs from the interpretation of a single prespecified test. The record does not provide enough information to determine how the investigators intended to address this issue.

The record lists one primary outcome and no posted secondary outcomes. It does not report an analysis plan, interim analyses, or details of any sensitivity analyses. These items are not reported in the registry record and should not be inferred from the outcome results alone.

The primary analysis population is defined as randomized participants who had 14C UBT performed on Day 28 to 34 after the last dose. The registry record does not provide participant-flow information or a missing-data procedure. In particular, it does not state how participants without the specified test were handled, whether their outcomes were imputed, or whether alternative assumptions were tested. The primary endpoint denominators are 19 for Group A, 19 for Group B, 10 for Group C, 10 for Group D, and 20 for control; the reasons for these analysis denominators are not reported.

The safety group denominators differ from the primary outcome denominators in Groups A and B. The record gives 20 participants at risk for safety outcomes in each of those groups, while the primary outcome results use 19. No explanation is reported. The registry record also does not identify the statistical tests underlying the p-values or the methods used to calculate the confidence intervals. These omissions limit assessment of whether all comparisons were handled consistently and how robust the findings are to missing outcomes or analysis choices.

14. 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 0% reporting threshold.

Most frequent non-serious adverse event terms

The safety results list serious adverse events for each group. The count of participants affected by a serious adverse event is 0 in Group A, 0 in Group B, 0 in Group C, 0 in Group D, and 0 in the control group. The record also lists 0 deaths in every group. The groups at risk are 20 for Group A, 20 for Group B, 10 for Group C, 10 for Group D, and 20 for control.

These figures describe what was recorded in the registry results; they do not establish that serious events could not occur or that the regimens have equivalent safety. The registry record does not list serious adverse event terms. It reports participants affected, rather than a detailed event-by-event account, and does not give additional information about event severity, timing, relatedness, or follow-up. Other adverse events are listed separately, but those counts are not the serious adverse event counts.

The safety denominators should not be confused with the primary endpoint denominators. The reason for the differing denominators in Groups A and B is not reported in the registry record.

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

The posted results describe the number of participants meeting the registry-defined endpoint in each group and provide estimated comparisons with control. The observed counts range from 5 participants with a negative test among 10 in Group C to 10 among 10 in Group D; control had 16 among 20. The corresponding risk-difference estimates vary in direction and have substantial uncertainty. Groups A, B, and C have intervals that extend across zero. Group D has an interval above zero but an unadjusted p-value of 0.129, and the record does not report enough methodological detail to explain that difference in inference.

These findings do not establish that a regimen works or does not work. The posted data are from a single-center study with limited group sizes, and the registry record does not report a multiplicity adjustment, detailed missing-data handling, or the statistical methods used for the intervals and tests. Those features affect how confidently the group comparisons can be interpreted.

The endpoint is a negative urea breath test at the assessment described in the registry record. It does not provide information about outcomes beyond that test result, and no secondary outcomes are posted. The registry record also does not provide the original sample-size rationale or enough information to assess whether the study was designed to make a definitive comparison among regimens.

The appropriate statistical reading is therefore descriptive and cautious: the record reports different observed counts and estimated risk differences, but the precision and analysis details do not support treating the estimates as exact or as proof of a general treatment effect. The sample-size illustrations are planning calculations based on observed effects, not evidence that the comparisons had adequate power or that any particular result is established.

16. Why This Trial Matters Statistically

This trial is statistically informative as an example of why event counts, effect estimates, and uncertainty need to be considered together. The endpoint counts are easy to interpret at face value, but the group denominators vary, and the resulting comparisons have intervals of differing breadth. A count that appears high in a small group can still leave substantial uncertainty about the underlying group proportion and its contrast with control.

The study also compares several regimens with a shared control. That structure raises a multiplicity question: the registry record reports unadjusted p-values but does not describe an adjustment or a prespecified comparison hierarchy. This matters because interpreting each p-value in isolation can overstate how decisive a set of comparisons is. The design and analysis plan would be needed to assess the intended interpretation.

The Group D results illustrate why methods details matter. Its risk-difference interval is reported zero, while its unadjusted p-value is 0.129. Since the record does not identify the interval or testing method, readers cannot determine whether the two summaries reflect different procedures or another feature of the analysis. Statistical reporting is most useful when the methods make such results interpretable.

Finally, the record’s primary outcome population depends on having a specified test result, while the reasons for differences between outcome and safety denominators are not given. Missing-data and participant-flow details are therefore important for evaluating the reported comparisons. These issues are relevant beyond this study: transparent reporting of analysis populations, uncertainty methods, multiplicity handling, and denominator changes helps readers distinguish observed patterns from strong conclusions.

17. 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 trial-specific limitations affect interpretation. The study is described as single-center and open-label, and the outcome groups are small, with primary endpoint denominators ranging from 10 to 20. The open-label design means treatment assignment was not masked, although the primary outcome is defined by a test result; the registry record does not report further procedures for assessment or blinding.

The primary endpoint timing is described in two ways. The outcome timeframe is given relative to the first dose, with different windows for Group D and the other groups, while the mITT definition specifies testing on Day 28 to 34 after the last dose. The record does not explain how these descriptions correspond or why the assessment windows differ. The control regimen’s frequency and duration are also not reported.

The registry record does not report the original sample-size justification, a full statistical analysis plan, methods for the confidence intervals or p-values, multiplicity handling, missing-data methods, or participant-flow details. It does not explain why the primary outcome denominators differ from the safety denominators in Groups A and B. The record reports no secondary outcomes, limiting the range of outcomes available for interpretation.

These limitations do not change the posted counts, but they constrain what can be concluded from them. In particular, they make it difficult to evaluate the precision, robustness, and intended inferential status of the comparisons.

18. Related Tutorials

19. Related Statistical Calculators

20. Sources

• ClinicalTrials.gov: Efficacy and Safety After Multiple Doses of TNP-2198 Capsules, Rabeprazole Sodium Enteric-coated Tablets and Amoxicillin Capsules in Helicobacter Pylori Infected-positive Participants — NCT06076694.
• Registry record last updated 2023-12-12; status last verified 2023-10.
• Results first posted 2023-12-12.
• 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.

21. Record Summary

The registry record describes NCT06076694, a completed, randomized, open-label, single-center, parallel-group study registered as Phase 2. The official title describes it as Phase Ic/IIb. The recorded enrollment is 80, with a start date of 2022-06-26 and primary completion on 2022-09-20. The sponsor is TenNor Therapeutics (Suzhou) Limited.

Participants were assigned to four TNP-2198 regimens or a rabeprazole-and-amoxicillin control regimen. The primary outcome was the count of participants with a negative urea breath test. The registry record reports outcome counts and comparisons with control, along with serious adverse event and death counts. It does not report secondary outcomes or detailed analysis methods.

The results are best read as observed group counts and uncertain comparisons. The record does not report the original sample-size rationale, multiplicity handling, missing-data methods, or enough statistical detail to resolve the difference between the Group D confidence interval and unadjusted p-value.