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 High Dose Esomeprazole Na for Prevention of Rebleeding After Successful Endoscopic Therapy of a Bleeding Peptic Ulcer (NCT01757275), a randomized phase 3 study. The primary outcome is Rate of Clinically Significant Rebleeding Within 72 Hours.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01757275 |
| Phase | Phase 3 |
| Condition | Bleeding Peptic Ulcer |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Quadruple |
| Enrollment | 239 |
| Arms in the primary outcome | n/a |
| Lead sponsor | AstraZeneca |
| Results posted | Yes |
2. Clinical Question
Population
Patients in China with a bleeding peptic ulcer who had successful endoscopic haemostatic therapy. The primary endpoint population was the full analysis set: randomised patients who started the randomised intravenous treatment with a bolus dose.
Intervention
High-dose intravenous esomeprazole sodium: an 80 mg bolus infusion followed by continuous infusion at 8 mg per hour for 72 hours.
Comparator
Intravenous cimetidine. The registry record does not report the comparator dosing regimen in the brief summary or the arm descriptions.
Primary question
What was the rate of clinically significant rebleeding within 72 hours in the trial population receiving high-dose intravenous esomeprazole sodium, compared with the rate in the cimetidine group?
The trial was designed around prevention of early rebleeding after endoscopic haemostasis. The endpoint definition included clinical signs, endoscopic verification, haemodynamic changes, and blood-loss criteria. This makes the question more specific than whether any later bleeding was recorded: the registry definition set out circumstances that qualified as clinically significant rebleeding during the stated period.
The record identifies the study as a randomized, double-blind, parallel-group phase III trial and reports enrollment of 239. It does not report the number assigned to each arm, the number included in each arm’s primary analysis, or the primary outcome event counts. Consequently, the registry record does not establish the observed difference between treatment groups or the precision of any such difference. Its outcome description explains what was intended to be assessed, but the comparative result is not reported in the registry record.
3. Trial Design
This was a phase III, randomized, double-blind, parallel-group study sponsored by AstraZeneca. The registry lists quadruple masking, randomized allocation, and a parallel-group model. Enrollment was 239. The study is marked completed; its start was recorded as 2013-02 and its primary completion as 2014-12.
The study concerned patients in China with bleeding peptic ulcers who had successful endoscopic haemostatic therapy. The official title specifies high-dose intravenous esomeprazole sodium as an 80 mg bolus infusion followed by continuous infusion of 8 mg per hour for 72 hours. The brief summary describes the comparison with intravenous cimetidine. The arm descriptions themselves are blank, so details beyond the named interventions and the specified esomeprazole regimen are not reported in the registry record.
Random allocation is intended to make treatment groups comparable, on average, with respect to measured and unmeasured characteristics. Masking can reduce the influence of treatment knowledge on care, reporting, and assessment. Those are general features of these design choices, not evidence that bias was absent in this particular trial. The registry record does not describe how randomization was generated or concealed, which people were masked, or how masking was maintained.
The primary outcome was the rate of clinically significant rebleeding within 72 hours. The primary endpoint population was the full analysis set, defined as all randomized patients who started the randomized intravenous treatment with a bolus dose. The record lists additional outcomes covering rebleeding over 7 and 30 days, endoscopic retreatment, surgery due to rebleeding, and blood units transfused. It does not report arm-level results for these outcomes.
The registry lists 9 outcome measures and 0 analyses. It does not report a protocol, a statistical analysis plan, a sample-size justification, or details of any interim analyses. The absence of those details means the intended inferential procedures and the rationale for the planned enrollment 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.
Before assignment: 17 patients were not assigned to treatment, 15 patients did not fulfil the eligibility criteria, 1 was due to patient decision, and 1 patient due to "other" (not enough experimental drug).
Overall Study
| Stage | Esomeprazole | Cimetidine |
|---|---|---|
| STARTED | 111 | 111 |
| COMPLETED | 102 | 98 |
| NOT COMPLETED | 9 | 13 |
Reasons for not completing this period:
| Reason | Esomeprazole | Cimetidine |
|---|---|---|
| Lost to Follow-up | 1 | 2 |
| Adverse Event | 3 | 3 |
| Withdrawal by Subject | 2 | 4 |
| Not treated | 3 | 4 |
Analysis population for the primary outcome, as defined in the registry: Full analysis set (FAS). All randomised patients, who started the randomised iv treatment (bolus dose), were included in the FAS.
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: Among 222 randomised patients, 215 patients received iv treatment: 108 patients in the esomeprazole treatment group and 107 patients in the cimetidine treatment group.
| Characteristic | Unit | Esomeprazole | Cimetidine | Total |
|---|---|---|---|---|
| Participants analysed | 108 | 107 | 215 | |
| Age, Continuous: Age | years | 42.4 (SD 12.79) | 41.8 (SD 12.96) | 42.1 (SD 12.85) |
| Age, Customized: <=65 years | participants | 104 | 103 | 207 |
| Age, Customized: >65 years | participants | 4 | 4 | 8 |
| Sex: Female, Male: Female | Participants | 25 | 24 | 49 |
| Sex: Female, Male: Male | Participants | 83 | 83 | 166 |
| Race/Ethnicity, Customized: Asian/Chinese | participants | 108 | 107 | 215 |
| Number of patients with one bleeding ulcer | participants | 108 | 107 | 215 |
| Forrest class: Ia | participants | 5 | 4 | 9 |
| Forrest class: Ib | participants | 58 | 64 | 122 |
| Forrest class: IIa | participants | 33 | 24 | 57 |
| Forrest class: IIb | participants | 12 | 15 | 27 |
| Bleeding ulcer size | mm | 8.2 (SD 4.8) | 8.1 (SD 3.6) | 8.1 (SD 4.3) |
| Ulcer location: Stomach | participants | 17 | 8 | 25 |
| Ulcer location: Duodenum | participants | 84 | 89 | 173 |
| Ulcer location: Stomach and Duodenum | participants | 7 | 10 | 17 |
| Number of patients with ulcers of different sizes: <=2 cm | participants | 105 | 106 | 211 |
| Number of patients with ulcers of different sizes: >2 cm | participants | 3 | 1 | 4 |
| Number of patients with single and multiple ulcers: Single | participants | 89 | 89 | 178 |
| Number of patients with single and multiple ulcers: Multiple | participants | 19 | 18 | 37 |
6. Primary Endpoint
The registry lists the primary outcome as Rate of Clinically Significant Rebleeding Within 72 Hours, measured over 72 hours.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is the rate of clinically significant rebleeding within 72 hours after successful endoscopic haemostatic therapy. The registry describes the outcome as a number of participants and identifies the primary analysis population as the full analysis set: randomized patients who started the randomized intravenous treatment with a bolus dose.
The definition allows rebleeding to qualify through specified clinical and endoscopic routes. One route requires clinical signs of bleeding together with endoscopic verification, such as blood in the stomach or verified active bleeding from a peptic ulcer. Blood in the stomach cannot be used as a criterion during the first 6 hours after primary endoscopic haemostasis. Another route requires at least two specified clinical indicators, including fresh blood or melaena, specified haemoglobin or haematocrit changes, or unstable circulation after previously stable circulation. A separate route is haematemesis, defined as vomiting significant amounts of fresh blood estimated by the investigator to exceed 200 ml.
General explanation: defining a clinically significant event helps distinguish events that meet prespecified clinical criteria from less clearly consequential observations. A time window also makes the outcome interpretable as an assessment of early rebleeding rather than bleeding over an unspecified period. These features clarify what the endpoint was intended to capture; they do not establish how many participants experienced it.
The registry record does not report the primary event counts by arm, the resulting rates, or a comparative effect estimate. It therefore does not allow the observed primary endpoint result or its precision to be assessed.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a clinically relevant comparison: high-dose intravenous esomeprazole sodium versus intravenous cimetidine after successful endoscopic haemostasis for a bleeding peptic ulcer. It also defines the primary outcome, its 72-hour observation window, and the analysis population. However, it does not report the comparative primary outcome results. There are no arm-level event counts or rates, effect estimate, confidence interval, or p value in the record.
Accordingly, no direction or size of a treatment-group difference can be stated from this registry entry. The endpoint description alone cannot show whether rebleeding was more or less frequent in either group. Nor can the enrollment figure substitute for outcome data: it describes the study’s enrollment, not how many participants experienced the primary event or contributed to each arm’s analysis.
General explanation: an effect estimate describes the observed contrast between groups, while a confidence interval communicates the range of values reasonably compatible with the data under the analysis assumptions. The width of an interval indicates precision; an interval does not by itself establish clinical importance. A p value is a measure of how incompatible the observed data are with a specified null model, given that model’s assumptions. Without these reported results, neither statistical evidence against a null model nor the precision of a comparative estimate can be evaluated.
The record lists enrollment of 239 and defines the full analysis set as all randomized patients who started the randomized intravenous treatment with a bolus dose. It does not state how many participants in each arm met that definition, whether any participants were excluded from analysis, or how missing endpoint information was handled. Thus, the relationship between total enrollment and the population contributing to any primary analysis is not reported in the registry record.
The study also lists outcomes over 7 and 30 days and outcomes concerning retreatment, surgery, and blood transfusions. No arm-level results for these measures are reported in the registry entry. The existence of multiple outcomes does not supply evidence about their results, and outcome definitions alone cannot support comparisons between treatment groups.
The record’s completed status means the study is marked as completed in the registry. It does not mean that the clinical outcomes or analyses are available in this entry. The registry lists 0 analyses, and the statistical analysis plan, interim analyses, and sample-size justification are not reported in the registry record. These absences limit assessment of how the endpoint was analyzed and whether the reported analytic approach matched the study’s intended plan.
Any interpretation should therefore remain descriptive of the registered design and endpoint. The available entry permits an account of the trial question and event definition, but not a conclusion about comparative effectiveness, the magnitude of an effect, statistical significance, or the certainty of a treatment-group difference.
9. Statistical Methods Explained
The registry describes a binary clinical endpoint recorded as a number of participants: whether a participant met the definition of clinically significant rebleeding within 72 hours. General explanation: a binary endpoint classifies each participant into an event or no-event category for the defined period. Group-level analysis can then compare how often the event occurred, but that comparison requires the numbers of events and the number of participants assessed in each group. Those primary outcome counts and rates are not reported in the registry record.
What does randomization contribute?
Randomization assigns participants to treatment groups using a chance-based process. General explanation: its purpose is to reduce systematic differences between groups at assignment, including differences that may not have been measured. This supports a fair comparison when the allocation process is implemented appropriately and the analysis preserves the randomized comparison. The registry identifies the study as randomized but does not report the sequence-generation method, allocation concealment, or details of implementation. Those methods are therefore not reported in the registry record.
The record identifies a parallel-group design, in which the groups receive their assigned treatments rather than crossing between treatments within the study. It also records double-blind in the design description and quadruple masking in the masking field. These labels indicate that masking was intended, but the record does not specify which roles were masked or how masking was maintained. General explanation: masking can limit changes in participant behavior, clinical management, or outcome assessment arising from knowledge of assigned treatment. A masking label alone cannot establish that blinding was successful.
How should the endpoint definition be read?
The outcome criteria combine clinical observations, endoscopic findings, blood measures, and signs of circulatory instability. The registry allows an endoscopy-based route requiring signs of bleeding and verification; a clinically based route requiring at least two listed indicators; or haematemesis estimated to exceed 200 ml. The criteria include blood in the stomach, active ulcer bleeding, fresh blood or melaena, specified haemoglobin and haematocrit changes, and unstable circulation following a stable period. Blood in the stomach is excluded as a criterion during the first 6 hours after primary endoscopic haemostasis.
General explanation: a detailed definition can make event classification more reproducible by setting explicit thresholds and combinations of signs. It can also make the endpoint sensitive to how observations are gathered and adjudicated. The registry record does not describe adjudication procedures, assessor training, or how disagreements about whether an event met the criteria were resolved. It also does not report the timing or completeness of individual assessments.
What can be inferred from the analysis population?
The stated full analysis set includes all randomized patients who started randomized intravenous treatment with a bolus dose. This definition clarifies that starting treatment is part of the stated population criterion. The record does not report arm-specific population counts or explain the treatment of participants randomized but not treated, participants with incomplete follow-up, or participants with deviations from treatment. Whether any such cases occurred is not reported in the registry record.
General explanation: analysis-population definitions affect which participants contribute to an estimate and what comparison the estimate represents. An analysis restricted by post-randomization events may differ from an analysis including every randomized participant. The registry definition should therefore be reported as written rather than assumed to be equivalent to another analysis population. The record does not provide enough information to determine the consequences of the stated population rule for the observed comparison.
What do confidence intervals and p values ordinarily convey?
General explanation: a confidence interval expresses uncertainty around an estimated quantity under the model and procedure used to calculate it. A narrow interval indicates greater precision than a wide interval, although precision and clinical importance are separate considerations. A p value assesses how unusual the observed data would be under a specified null hypothesis and statistical model. It is not the probability that the null hypothesis is true, and it does not measure the size or practical importance of an effect.
No confidence interval, p value, or effect estimate for the primary comparison is reported in the registry record. The entry lists 0 analyses. It therefore does not identify the analysis model or provide numerical inferential results to interpret. A recalculation from summary statistics is also not available because the requisite primary outcome summaries are not reported.
What does the planning information establish?
General explanation: a sample-size calculation is a planning exercise based on assumptions about the event frequency, target effect, allocation, significance level, and desired power. It does not describe observed evidence after a trial has been completed. The record describes a planning-illustration approach based on an observed effect, with a two-sided significance level of 0.05, equal allocation, and a normal approximation. It also describes the effect to detect as a stated fraction of the observed effect.
No numerical planning estimates are reported in the registry record. The trial’s own sample-size justification is not reported, and the planning illustration cannot be treated as observed power. General explanation: observed power calculated from an observed effect does not replace an effect estimate and its confidence interval; interpretation of the trial results depends on the observed data and their uncertainty.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 9 outcome measures. Besides clinically significant rebleeding within 72 hours, the listed outcomes include rebleeding during 7 and 30 days, endoscopic retreatment within 72 hours and within 30 days, surgery due to rebleeding within those periods, and blood units transfused within those periods. The record does not describe a hierarchy for these outcomes, a multiplicity adjustment, or which outcomes were intended to support confirmatory claims. Those details are not reported in the registry record.
General explanation: when several outcomes or repeated comparisons are tested, the chance of at least one apparently unusual result can increase if each is assessed separately using the same decision rule. A prespecified hierarchy or adjustment can address that issue. Without the statistical analysis plan, it is not possible to determine whether or how multiplicity was handled for this trial.
The full analysis set is defined as all randomized patients who started the randomized intravenous treatment with a bolus dose. The entry does not report the number in that set by arm, missing endpoint counts, reasons for missing data, or the method used to handle missing outcomes. It also does not report whether participants were excluded from the primary analysis or how protocol deviations were addressed. These features are important to understanding which observations supported an estimate and whether missingness could have affected the comparison.
The registry lists 0 analyses and does not report a statistical analysis plan, interim analyses, or a sample-size justification. The fact that the study is marked completed does not fill these reporting gaps. Without outcome results and analysis details, the registry record cannot establish how missing data, multiple outcomes, or analysis-population decisions affected the conclusions.
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 |
|---|---|---|---|
| Esomeprazole | 5 | 110 | 4.5% |
| Cimetidine | 5 | 105 | 4.8% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Esomeprazole | 22 of 110 |
| Cimetidine | 20 of 105 |
Most frequent serious adverse event terms
| Event term | Organ system | Esomeprazole | Cimetidine |
|---|---|---|---|
| Duodenal ulcer haemorrhage | Gastrointestinal disorders | 2 of 110 | 2 of 105 |
| Gastric ulcer haemorrhage | Gastrointestinal disorders | 1 of 110 | 0 of 105 |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | 0 of 110 | 1 of 105 |
| Bronchitis | Infections and infestations | 0 of 110 | 1 of 105 |
| Blood fibrinogen decreased | Investigations | 1 of 110 | 0 of 105 |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 1 of 110 | 0 of 105 |
| Persecutory delusion | Psychiatric disorders | 0 of 110 | 1 of 105 |
| Nephrolithiasis | Renal and urinary disorders | 0 of 110 | 1 of 105 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Esomeprazole | Cimetidine |
|---|---|---|---|
| Duodenal ulcer haemorrhage | Gastrointestinal disorders | 2 of 110 | 2 of 105 |
| Pyrexia | General disorders | 2 of 110 | 2 of 105 |
| Diarrhoea | Gastrointestinal disorders | 2 of 110 | 1 of 105 |
| Melaena | Gastrointestinal disorders | 1 of 110 | 2 of 105 |
| Dizziness | Nervous system disorders | 1 of 110 | 1 of 105 |
| Cough | Respiratory, thoracic and mediastinal disorders | 2 of 110 | 0 of 105 |
| Constipation | Gastrointestinal disorders | 1 of 110 | 1 of 105 |
| Bronchitis | Infections and infestations | 0 of 110 | 1 of 105 |
| Nasopharyngitis | Infections and infestations | 1 of 110 | 0 of 105 |
| Upper respiratory tract infection | Infections and infestations | 0 of 110 | 1 of 105 |
Serious events with the highest arm-level rate: duodenal ulcer haemorrhage (1.9%), gastrointestinal haemorrhage (1.0%), bronchitis (1.0%), persecutory delusion (1.0%), nephrolithiasis (1.0%).
The registry reports serious adverse event figures for the Esomeprazole and Cimetidine groups. For Esomeprazole, 5 participants were recorded as affected by serious adverse events among 110 at risk; 22 were recorded as affected by other adverse events among 110 at risk. For Cimetidine, the corresponding figures are 5 of 105 for serious adverse events and 20 of 105 for other adverse events. These are the posted counts and at-risk denominators; they should not be read as comparative rates calculated from the registry record.
The listed serious adverse event terms and percentages are duodenal ulcer haemorrhage, 1.9%; gastrointestinal haemorrhage, 1.0%; bronchitis, 1.0%; persecutory delusion, 1.0%; nephrolithiasis, 1.0%; and gastric ulcer haemorrhage, 0.9%. The record does not make clear whether these terms overlap within participants or provide group-specific counts for each listed term. The listed percentages therefore should not be treated as a complete account of all events or as evidence of a difference between groups.
Death counts are not reported in the registry record. The entry also does not provide details about event severity beyond the serious and other categories, timing, duration, relatedness assessments, or statistical comparisons. General explanation: adverse event counts describe events recorded during a study, but interpretation depends on definitions, observation time, completeness of reporting, and the comparison being made. These figures alone do not establish causation or a treatment-group safety difference.
12. What the Result Does, and Does Not, Mean
The registry entry establishes the study question and design: a randomized, double-blind, parallel-group phase III comparison involving high-dose intravenous esomeprazole sodium and intravenous cimetidine after successful endoscopic haemostasis for bleeding peptic ulcer. It specifies the esomeprazole regimen, the primary 72-hour rebleeding outcome, and the full analysis set definition. It also lists later rebleeding and other clinical outcomes.
What the record does not establish is the primary outcome result. The arm-specific event counts, rates, treatment contrast, confidence interval, and p value are not reported in the registry record. As a result, it is not possible to describe which group had more or fewer clinically significant rebleeding events, estimate the magnitude of a difference, or assess its precision. Enrollment of 239 does not answer those questions.
General explanation: a trial’s design describes how evidence was intended to be collected; its results describe what the collected data showed. These are distinct. A well-defined endpoint and randomized design can support a meaningful comparison, but they do not substitute for the numerical results and analysis details needed to interpret that comparison.
The entry’s status is completed, yet the primary comparative analysis is not included. The registry lists 0 analyses. Details of the randomization procedure, masking implementation, missing-data handling, multiplicity strategy, interim analyses, and the trial’s own sample-size justification are also not reported in the registry record. The listed serious adverse event counts offer limited descriptive safety information, but the entry does not report deaths or a formal comparison of adverse event risks.
Thus, the record supports a description of the trial’s intended clinical question, treatment regimen, endpoint criteria, and some adverse event counts. It does not support a conclusion that one treatment reduced or increased rebleeding, that the groups differed statistically, or that either treatment has a particular safety profile. Such conclusions require outcome and analysis information that is not reported in this registry entry.
13. Why This Trial Matters Statistically
This trial is statistically notable for the structure of its clinical question. It focuses on a defined event during a fixed early period after successful endoscopic haemostasis, with criteria combining clinical indicators and endoscopic verification. That definition makes clear that the target is clinically significant rebleeding rather than an unspecified report of bleeding. The full analysis set is also described, so the registry records an explicit rule for who was intended to contribute to the primary assessment.
The study is identified as randomized, double-blind, parallel-group, and phase III, with enrollment of 239. These design details help readers understand the planned comparison, but they are not themselves evidence of an outcome difference. Statistical interpretation requires the observed events, group denominators, an estimate of the contrast, and uncertainty around that estimate. The registry record does not report those primary comparative results.
General explanation: this distinction is central to trial appraisal. Design features speak to how a comparison was organized, while estimates and their uncertainty describe what the data support. A detailed endpoint definition improves interpretability, but does not establish the event frequency or the precision of a treatment comparison. Likewise, a completed status does not mean that the registry entry contains a completed statistical report.
The case also illustrates why reporting of analysis methods matters. The record lists multiple outcomes but does not report a multiplicity strategy, a statistical analysis plan, interim analyses, or a trial-specific sample-size justification. It lists 0 analyses. Without those elements and the primary results, readers cannot assess whether the intended analysis was followed or how robust the conclusions might be.
The statistical importance of the entry is therefore its clear specification of a focused clinical endpoint alongside substantial gaps in reported comparative results. It can orient readers to the trial design and outcome definition, but not answer the treatment-effect question.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The principal limitation of this registry entry is that it describes the primary endpoint without reporting its results. There are no arm-specific primary event counts, rates, effect estimates, confidence intervals, or p values. The record therefore does not allow the comparative result to be quantified or its precision assessed.
Several details needed to evaluate the analysis are not reported in the registry record. These include the randomization method and allocation concealment, which roles were masked, how masking was maintained, the statistical analysis plan, interim analyses, and the trial’s own sample-size justification. The entry also does not report the number in the full analysis set by arm, missing endpoint data, reasons for missingness, or the method used to handle missing outcomes.
The registry lists multiple outcomes, but does not report a multiplicity strategy or specify how the outcomes were prioritized analytically. It does not provide arm-level results for the secondary outcomes. The description of the serious adverse event terms does not establish whether participants could contribute to multiple terms, and death counts are not reported in the registry record.
The primary endpoint definition is detailed, but the registry does not describe outcome adjudication, assessment procedures, or how ambiguous cases were handled. The comparator arm description is blank, and its dosing regimen is not reported in the registry record. The study is marked completed, but completion status does not resolve these reporting limitations or substitute for outcome data.
These limitations concern what this entry reports; they do not establish that the underlying trial lacked methods or analyses. They mean that those details and results cannot be evaluated from the registry record.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: High Dose Esomeprazole Na for Prevention of Rebleeding After Successful Endoscopic Therapy of a Bleeding Peptic Ulcer — NCT01757275.
- Registry record last updated 2016-03-08; status last verified 2016-02.
- Results first posted 2016-03-08.
- 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.
Continue through the Clinical Biostats statistical pathway
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18. Record Summary
NCT01757275 is a completed phase III randomized, double-blind, parallel-group study sponsored by AstraZeneca. Enrollment was 239; the recorded start was 2013-02 and primary completion was 2014-12. The study concerned patients in China with bleeding peptic ulcers after successful endoscopic haemostatic therapy.
The specified esomeprazole sodium regimen was an 80 mg bolus infusion followed by continuous infusion at 8 mg per hour for 72 hours; the brief summary describes comparison with intravenous cimetidine. The primary endpoint was clinically significant rebleeding within 72 hours, assessed in randomized patients who started treatment with a bolus dose.
The record lists additional rebleeding, retreatment, surgery, and transfusion outcomes. It reports limited adverse event counts, but no primary comparative outcome results or analyses. The statistical analysis plan, trial-specific sample-size justification, missing-data methods, and multiplicity approach are not reported in the registry record.