This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for ERADICATE Hp - Treating Helicobacter Pylori With RHB-105 (NCT01980095), a randomized phase 3 study. The primary outcome is The Occurrence of H. Pylori Eradication as Confirmed Via 13C UBT Testing.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01980095 |
| Phase | Phase 3 |
| Condition | Dyspepsia, Helicobacter Pylori Infection |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Triple |
| Enrollment | 119 |
| Arms in the primary outcome | n/a |
| Lead sponsor | RedHill Biopharma Limited |
| Results posted | Yes |
2. Clinical Question
Population
The trial concerned patients with non-investigated dyspepsia and confirmed Helicobacter pylori infection. The primary endpoint description defines the modified intent-to-treat population as participants who received at least 1 dose of randomized study treatment and underwent a 13C urea breath test at Visit 4. That population included 66 participants in the RHB-105 group and 37 in the placebo group. The registry reports enrollment of 119 overall, which is distinct from the endpoint population definition.
Intervention
RHB-105 was an oral capsule combination containing 2 antibiotics and a proton pump inhibitor in a single capsule. The registry describes it as an “all-in-one” product. Dose, treatment duration, and further administration details are not reported in the registry record.
Comparator
The comparator was placebo: capsules that looked like the RHB-105 product but contained no active ingredient. The study was randomized, placebo-controlled, and triple-masked. The registry does not specify the allocation ratio.
Primary question
The primary endpoint was the occurrence of H. pylori eradication, assessed by 13C urea breath testing 28-56 days after treatment completion. The registry describes a planned one-sample Z-test assessing whether the active treatment was superior to 70%. The stated endpoint definition counts participants with negative test results as successes; positive, indeterminate, not assessable, or missing results are counted as failures. A primary outcome result, including the number of successes or a test result, is not reported in the registry record.
3. Trial Design
This was a randomized, placebo-controlled phase 3 study using a parallel-group design. Triple masking was reported. These features describe how the trial was organized, but the registry does not specify which trial roles were masked or how the randomization sequence was generated and implemented. The allocation ratio is also not reported in the registry record.
The registry lists 119 participants enrolled. The primary endpoint description uses a modified intent-to-treat population: participants had to receive at least 1 dose of randomized study treatment and undergo a 13C urea breath test at Visit 4. It reports 66 participants in the RHB-105 group and 37 in the placebo group for this population. The registry does not explain the difference between overall enrollment and the participants included in this endpoint population.
Participants received either RHB-105 or placebo. RHB-105 was an oral capsule combining 2 antibiotics and a proton pump inhibitor, while the placebo capsules looked like the active product and contained no active ingredient. The registry does not report the dose, treatment duration, adherence measures, or rules for changing or stopping treatment.
The study start is listed as 2013-11 and primary completion as 2015-06; the overall status is completed. These dates describe the registry record and do not establish when results were submitted or published. The sponsor is RedHill Biopharma Limited. The registry identifies 2 outcome measures and 1 analysis, but does not give details about how the secondary outcome was analyzed or how the analysis population was defined for it.
The study addresses eradication in patients with confirmed infection and non-investigated dyspepsia, rather than dyspepsia alone. Its placebo comparison is distinct from a comparison with another active treatment. Further design details, including a sample-size justification and interim-analysis plan, 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
| Stage | RHB-105 | Placebo |
|---|---|---|
| STARTED | 78 | 41 |
| Treated | 77 | 41 |
| COMPLETED | 63 | 30 |
| NOT COMPLETED | 15 | 11 |
Reasons for not completing this period:
| Reason | RHB-105 | Placebo |
|---|---|---|
| Lost to Follow-up | 6 | 7 |
| Withdrawal by Subject | 2 | 3 |
| Poor compliance | 5 | 0 |
| Safety issue | 0 | 1 |
| Study drug discontinued | 1 | 0 |
| Randomized by mistake | 1 | 0 |
Analysis population for the primary outcome, as defined in the registry: The mITT Population included all subjects who received at least 1 dose of randomized study treatment and underwent a 13C UBT test at Visit 4. This population consisted in 66 subjects in the RHB-105 group and 37 subjects in the placebo group.
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
| Characteristic | Unit | RHB-105 | Placebo | Total |
|---|---|---|---|---|
| Participants analysed | 77 | 41 | 118 | |
| Age, Continuous | years | 46.2 (SD 10.56) | 45.8 (SD 9.52) | 46 (SD 10.18) |
| Sex: Female, Male: Female | Participants | 28 | 16 | 44 |
| Sex: Female, Male: Male | Participants | 49 | 25 | 74 |
6. Primary Endpoint
The registry lists the primary outcome as The Occurrence of H. Pylori Eradication as Confirmed Via 13C UBT Testing, measured over 28-56 days after completion of treatment.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint measures whether a participant was classified as having H. pylori eradication based on a 13C urea breath test. Testing was specified for 28-56 days after completion of treatment. A negative test was defined as a treatment success. A positive test, or an indeterminate, not assessable, or missing result, was defined as a treatment failure.
This is a binary participant-level outcome: each eligible participant is classified as a success or a failure under the stated rules. Such an endpoint can describe the proportion of participants meeting a defined outcome, while its interpretation depends on the population included and the handling of incomplete or uncertain test results. Here, the population was limited to participants who received at least 1 dose and underwent the specified test at Visit 4, although missing test results within that defined population were classified as failures.
The registry identifies the endpoint as a count of participants and gives the planned comparison with a 70% benchmark. It does not report the number of participants who tested negative, the resulting eradication estimate, an uncertainty interval, or the test statistic and p-value. Therefore the endpoint definition and planned analysis can be described, but the registry record does not support a numerical conclusion about the observed eradication result.
General: a prespecified objective test can provide a consistent rule for classifying the outcome, while the timing of assessment defines the period to which that classification applies. The reported testing window is part of the endpoint meaning; it should not be treated as a result at a different follow-up time.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry describes a trial designed to evaluate RHB-105 against placebo and specifies a primary endpoint based on H. pylori eradication by 13C urea breath testing. It also describes a planned one-sample Z-test against a 70% benchmark for the active treatment. However, the primary outcome has several categories or time points and is not reduced to one comparison in the registry results presented for this analysis. No primary success count, estimated eradication proportion, confidence interval, test statistic, or p-value is reported in the registry record.
That absence limits what can be inferred. The trial design and endpoint rules do not themselves establish the observed eradication rate or whether the planned statistical criterion was met. The registry record also does not provide a direct numerical active-versus-placebo primary endpoint comparison. Consequently, an effect estimate, its precision, and the strength of evidence for a difference between treatment groups cannot be described from the recorded primary outcome information.
The endpoint population consisted of participants who received at least 1 dose and underwent a 13C urea breath test at Visit 4. It included 66 participants assigned to RHB-105 and 37 assigned to placebo. These figures clarify the analysis population described for the primary endpoint, but they are not outcome counts and should not be interpreted as the number who achieved eradication. Overall enrollment was 119.
For the primary endpoint, positive, indeterminate, not assessable, and missing test results were designated failures. This rule is important because it makes the endpoint classification conservative with respect to incomplete or uncertain tests, but it does not reveal how many participants had each type of result. The record does not explain exclusions from the modified intent-to-treat population or report analyses using other analysis populations.
General: an estimate describes the observed result, while a confidence interval describes the range of values compatible with the data under the method used. Without a reported estimate and uncertainty interval, the precision of the primary endpoint cannot be assessed. A planned hypothesis test is not a substitute for its result, and the existence of a planned benchmark does not show whether the observed outcome was above or below it.
The serious and other adverse-event counts are separate safety information, not substitutes for the primary efficacy result. They describe events recorded in the listed groups, but do not by themselves establish that an event was caused by treatment or provide a complete benefit-risk assessment. The registry record should therefore be read as describing the design, endpoint definition, analysis population, and posted safety counts, with the primary efficacy result not reported in a form that permits the intended statistical interpretation.
9. Statistical Methods Explained
The registry describes the primary endpoint as the occurrence of H. pylori eradication confirmed by 13C urea breath testing. The endpoint is binary at the participant level: a negative result is success, while positive, indeterminate, not assessable, or missing results are failures. Its specified assessment window is 28-56 days after treatment completion. The analysis population was modified intent-to-treat, defined as participants who received at least 1 dose of randomized study treatment and underwent the test at Visit 4.
What does the planned one-sample test ask?
The registry says the active treatment was to be tested for superiority to 70% using a one-sample Z-test. In general, a one-sample test compares an estimate from one group with a specified reference value. In this case, the reference is the 70% threshold stated in the registry. A Z-test uses a standardized measure of how far the observed estimate is from the value under the tested hypothesis, relative to its estimated uncertainty. The test can be used to assess compatibility with a benchmark under its assumptions; it is not, by itself, a direct comparison between the active and placebo groups.
The registry's description of the hypothesis is phrased as testing whether active treatment is superior to 70% against an alternative that it is statistically indistinguishable or less than 70% effective. It does not provide the formal null and alternative notation, the test statistic, the observed estimate, or a p-value. The planned test should therefore be described as recorded, without asserting that a particular statistical result was obtained.
What does the participant count represent?
The endpoint is listed as a count of participants, but the statistical question concerns the success classification defined by the breath test. A count alone does not communicate the proportion of the analysis population with eradication unless the relevant success count and denominator are both available. The registry reports the group sizes in the modified intent-to-treat population, but does not report the corresponding success counts in the primary outcome record.
General: binary outcome methods commonly estimate the fraction of participants meeting a defined outcome and quantify uncertainty around that estimate. A confidence interval expresses the uncertainty associated with an estimate under a particular statistical method. It does not guarantee that the true value lies within a fixed range, and its interpretation depends on the design and assumptions. No primary endpoint confidence interval is reported in the registry record.
Why does the analysis population matter?
The modified intent-to-treat definition includes participants who received at least 1 dose and had the specified test. It is not identical, by definition, to every participant enrolled or randomized. The registry reports overall enrollment of 119 and endpoint population sizes of 66 for RHB-105 and 37 for placebo, but does not describe the reasons participants were not included in the endpoint population. Comparisons across analyses can be affected by differing populations, so the population definition is essential context for interpreting any estimate. No alternative primary analysis population or sensitivity analysis is reported in the registry record.
How should missing outcome information be understood?
The endpoint rule explicitly classifies missing, indeterminate, and not assessable breath-test results as failures. This is a stated classification rule, not a report of how many participants had those outcomes. The registry does not provide a breakdown of positive, negative, indeterminate, not assessable, or missing test results. Nor does it report whether additional sensitivity analyses assessed the effect of this rule.
General: missing-data rules matter because the classification of unobserved outcomes can influence an estimated event rate. Treating missing measurements as failures is one possible prespecified approach, but readers still need the number and pattern of missing results to understand its practical impact. Those details are not reported in the registry record.
What do planning illustrations mean?
The sample-size material is described as a planning illustration computed from the observed effect, not as the trial's own design justification. Its stated assumptions include a two-sided significance level of 0.05, equal allocation between the two arms, a normal approximation, and an effect to detect expressed as a fraction of the observed effect. Such illustrations describe hypothetical planning scenarios under stated assumptions; they are not observed power and do not establish the trial's original sample-size rationale. The original sample-size justification is not reported in the registry record.
General: planning calculations estimate how much information a future study might need to detect a specified effect under chosen assumptions. They do not change the data collected in a completed trial, and they should not be presented as evidence that the completed study did or did not have adequate power. The available record does not report the trial's own assumptions, interim analyses, or full statistical analysis plan.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 2 outcome measures and 1 analysis, but the primary outcome itself has several categories or time points and is not reduced to one comparison in the posted results. The registry record does not report a multiplicity-adjustment procedure, a hierarchy among outcomes, or how multiple endpoint assessments were handled statistically. It is not possible to determine from the available information whether or how multiplicity was addressed in the trial analysis.
Multiplicity can arise when several outcomes, time points, or statistical comparisons are considered. General: testing many hypotheses without an appropriate strategy can increase the chance of at least one apparently notable result arising by chance. Strategies may include prespecified hierarchies or adjustments, but no specific strategy should be attributed to this study unless it is reported. The registry record does not provide enough detail to characterize such a strategy.
The primary endpoint definition classifies positive, indeterminate, not assessable, and missing breath-test results as failures. The modified intent-to-treat population is defined as participants who received at least 1 dose and underwent the 13C urea breath test at Visit 4. The record does not report how many participants had each test-result category, why participants were absent from that population, or whether additional missing-data analyses were performed.
These stated rules help define the endpoint, but they do not establish the extent of missingness or its effect on the observed result. The record also does not report a per-protocol analysis, an intention-to-treat analysis of all randomized participants, or sensitivity analyses using alternative assumptions. Such analyses should not be presumed to have been conducted.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| RHB-105 | 1 | 77 | 1.3% |
| Placebo | 1 | 41 | 2.4% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| RHB-105 | 38 of 77 |
| Placebo | 17 of 41 |
Most frequent serious adverse event terms
| Event term | Organ system | RHB-105 | Placebo |
|---|---|---|---|
| Anemia of Grade 3 | Blood and lymphatic system disorders | 1 of 77 | 0 of 41 |
| Perirectal Abscess | Skin and subcutaneous tissue disorders | 0 of 77 | 1 of 41 |
Most frequent non-serious adverse event terms
| Event term | Organ system | RHB-105 | Placebo |
|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | 11 of 77 | 4 of 41 |
| Headache | Nervous system disorders | 10 of 77 | 4 of 41 |
| Chromaturia | Renal and urinary disorders | 10 of 77 | 1 of 41 |
| Abdominal tenderness | Gastrointestinal disorders | 5 of 77 | 3 of 41 |
| Dizziness | Nervous system disorders | 3 of 77 | 3 of 41 |
| Flatulence | Gastrointestinal disorders | 2 of 77 | 3 of 41 |
Serious events with the highest arm-level rate: perirectal abscess (2.4%), anemia of grade 3 (1.3%).
The registry lists serious adverse events for 1 of 77 participants at risk in the RHB-105 group and 1 of 41 participants at risk in the placebo group. It lists other adverse events for 38 of 77 participants at risk in the RHB-105 group and 17 of 41 participants at risk in the placebo group. These are counts of participants with events and the corresponding group sizes at risk as recorded; they are not the primary efficacy endpoint.
The listed serious adverse-event terms include Perirectal Abscess at 2.4% and Anemia of Grade 3 at 1.3%. The registry record does not make a group attribution for these term percentages in the information, so they should not be assigned to a particular treatment group. Death counts are not reported in the registry record.
General: an adverse event recorded during a trial is not automatically caused by the treatment. Group counts do not, on their own, establish causation, severity patterns beyond the recorded terms, or comparative risk. Interpretation also depends on event definitions, collection procedures, duration of observation, and participant follow-up; those details are not reported in the registry record. The listed figures should therefore be read as descriptive safety counts, not as proof for or against a treatment effect.
12. What the Result Does, and Does Not, Mean
The registry record identifies a randomized, placebo-controlled phase 3 study of RHB-105 in patients with confirmed H. pylori infection and non-investigated dyspepsia. It describes an endpoint based on eradication assessed by 13C urea breath testing 28-56 days after treatment completion, and a planned one-sample Z-test against the 70% benchmark. It also defines the modified intent-to-treat population and gives its group sizes.
Those design details do not establish the trial's observed eradication result. The registry does not report a primary success count, estimated eradication proportion, confidence interval, test statistic, or p-value in a form that permits interpretation of the planned test. It also does not provide a direct numerical comparison of the primary endpoint between RHB-105 and placebo in the record. As a result, the evidence for the primary efficacy question and the precision of any treatment effect cannot be assessed from these posted primary outcome details.
The adverse-event counts provide separate descriptive information. They indicate how many participants were recorded with serious and other adverse events in each group, but do not identify causation or provide a complete account of safety. The named serious adverse-event terms and percentages should be interpreted within the limited detail recorded; the registry does not attribute those term percentages to a group in the available information.
General: a completed trial does not necessarily have every result available in its registry record, and a protocol-level plan is distinct from an observed result. Likewise, a planning illustration based on an observed effect is not observed power and is not evidence that the trial's own design used those assumptions. The record supports description of the study and its planned endpoint method, but not a claim that RHB-105 did or did not meet the primary statistical objective.
13. Why This Trial Matters Statistically
This trial is statistically notable for the distinction between a benchmark question and a randomized treatment comparison. The registry describes a one-sample Z-test for whether active treatment was superior to 70%. That test asks how the active-group endpoint relates to a specified threshold. A separate comparison of RHB-105 with placebo would address the difference between randomized groups. The registry's stated primary analysis description should not be recast as a placebo comparison.
The record also makes the endpoint population and outcome classification explicit. Participants had to receive at least 1 dose and undergo the 13C urea breath test at Visit 4 to be included in the modified intent-to-treat population. Negative tests counted as successes; positive, indeterminate, not assessable, and missing results counted as failures. These definitions matter because a statistical estimate is meaningful only in relation to a clearly specified population, outcome, and follow-up window.
At the same time, the primary outcome result is not reported in a form that allows a reader to evaluate the planned test or the precision of the estimate. This creates an important interpretive boundary: a detailed endpoint rule and analysis plan can be reported even when the observed primary result is unavailable in the registry record.
General: statistical transparency depends on more than naming a test. Readers also need the estimate, uncertainty, analysis population, handling of incomplete observations, and explanation of comparisons. The record supplies some design and endpoint definitions but does not report several of these outcome details. Separating what the registry specifies from what it does not report helps avoid treating study design as evidence of a result.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The most important limitation for statistical interpretation is that the registry record does not report the primary endpoint result as a success count or estimated eradication proportion, and does not give a confidence interval, test statistic, or p-value. The planned one-sample Z-test against 70% is described, but its observed result cannot be evaluated from the outcome information available. A direct numerical primary endpoint comparison between RHB-105 and placebo is also not reported.
The endpoint population is defined as participants who received at least 1 dose and underwent a 13C urea breath test at Visit 4. The record reports 66 participants in the RHB-105 group and 37 in the placebo group for this population, alongside overall enrollment of 119. It does not explain why the endpoint population differs from enrollment, describe exclusions, or report outcome counts by test-result category. Consequently, the impact of missing or unassessable tests cannot be quantified, even though the endpoint rules classify such results as failures.
The registry does not report the original sample-size justification, allocation ratio, randomization implementation, or interim-analysis plan. It also does not provide the full statistical analysis plan, a multiplicity strategy, or details of secondary-outcome analyses. These omissions prevent a fuller assessment of whether all analyses followed prespecified methods and how uncertainty across outcomes was handled.
Safety information is also limited. Group-level counts are recorded for serious and other adverse events, but the registry information does not give a detailed event-level account, establish causality, or attribute the listed serious-event term percentages to a treatment group. Death counts are not reported in the registry record. These limitations do not imply that unreported events occurred or did not occur; they mark what can and cannot be determined from the registry information.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: ERADICATE Hp - Treating Helicobacter Pylori With RHB-105 — NCT01980095.
- Registry record last updated 2019-09-24; status last verified 2019-09.
- Results first posted 2017-01-10.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
NCT01980095 is a completed, randomized, triple-masked, parallel-group, placebo-controlled phase 3 study sponsored by RedHill Biopharma Limited. It enrolled 119 participants and examined RHB-105, an oral capsule combining 2 antibiotics and a proton pump inhibitor, against placebo in patients with confirmed H. pylori infection and non-investigated dyspepsia.
The primary endpoint was H. pylori eradication by 13C urea breath test 28-56 days after treatment completion. The modified intent-to-treat population included participants who received at least 1 dose and underwent the test at Visit 4, with 66 participants in the RHB-105 group and 37 in the placebo group. The registry describes a planned one-sample Z-test against a 70% benchmark. The primary outcome result is not reported in a form that supports assessment of the planned test or a numerical comparison between groups.
The registry records serious adverse events in 1 of 77 participants at risk in each group, and other adverse events in 38 of 77 participants at risk with RHB-105 and 17 of 41 with placebo. These are descriptive safety counts and do not establish causation.