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 Long-term Use of Takepron on the Prevention of Recurrence of Gastric/Duodenal Ulcer in Patients Receiving Non-steroidal Anti-inflammatory Drugs (NCT02099708), a registered phase not stated study. The primary outcome is Frequency of Adverse Drug Reactions.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02099708 |
| Phase | Phase not stated |
| Condition | Gastric or Duodenal Ulcers |
| Allocation | Not Stated |
| Design model | Not Stated |
| Masking | Not Stated |
| Enrollment | 3502 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Takeda |
| Results posted | Yes |
2. Clinical Question
Population
People receiving oral non-steroidal anti-inflammatory drugs (NSAIDs) and at risk of gastric or duodenal ulcer recurrence. The primary endpoint population was the safety analysis set: participants who received at least one dose of the open-label study drug.
Intervention
Lansoprazole 15 mg, taken orally once daily as capsules or orally disintegrating tablets for up to 12 months.
Comparator
No comparator arm is listed. The registry record does not state an allocation method, and this is not a randomized comparison.
Primary question
What frequency of adverse drug reactions was recorded during long-term lansoprazole use in the routine clinical setting? The registry defines an adverse drug reaction as an event considered possibly associated with a medicinal product.
The study also recorded endoscopic examinations, gastric or duodenal ulcers, hemorrhagic lesions, treatment for ulcers or lesions, and treatment outcomes. These outcomes provide context about the conditions and events monitored, but they do not create a controlled comparison. Without a comparator, the record cannot establish how the observed event frequency differs from what would have occurred without lansoprazole or with another treatment.
The registry lists enrollment of 3502 and identifies the primary endpoint population as participants who received at least one dose. The posted safety summary lists 3302 participants at risk for the reported adverse-event categories. The registry record does not report a numerical value for the primary endpoint itself, so the frequency of adverse drug reactions cannot be summarized from that endpoint description alone.
3. Trial Design
This was a completed long-term use survey in the routine clinical setting, rather than a randomized comparison. The registry record lists Takeda as the sponsor, an enrollment of 3502, a study start of 2010-10, and primary completion in 2014-03. The intervention listed is lansoprazole 15 mg, given orally once daily as capsules or orally disintegrating tablets for up to 12 months.
Only one treatment arm is listed. The registry does not state an allocation method and does not identify a control group. As a result, the design does not support a like-for-like comparison between lansoprazole and another treatment or no treatment. The record also does not report how clinicians selected participants or whether use of the capsules or orally disintegrating tablets followed a particular assignment process.
The primary endpoint concerns the frequency of adverse drug reactions among the safety analysis set, defined as participants who received at least one dose of open-label study drug. The record separately lists secondary outcomes concerning endoscopic examinations, ulcers, hemorrhagic lesions, and their treatment and outcomes. It does not provide a detailed account of follow-up completeness or the methods used to assess each secondary outcome.
The registry marks the study as completed, but completion status does not itself establish that every enrolled participant completed the full treatment period or underwent every planned assessment. Participant flow and the number completing follow-up are not reported in the registry record. Nor are the reasons for any discontinuations or the timing of assessments described in the available study details.
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: Patients with a history of gastric or duodenal ulcers and requiring long-term use of nonsteroidal anti-inflammatory drugs were enrolled in the study.
Overall Study
| Stage | Lansoprazole 15 mg |
|---|---|
| STARTED | 3502 |
| Safety Analysis Set (SAS) | 3302 |
| COMPLETED | 3302 |
| NOT COMPLETED | 200 |
Reasons for not completing this period:
| Reason | Lansoprazole 15 mg |
|---|---|
| Data Not Available | 30 |
| Lost to Follow-up | 141 |
| Other | 29 |
Analysis population for the primary outcome, as defined in the registry: Safety analysis set (SAS) - All participants who received at least 1 dose of open-label study drug.
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
Population: Safety analysis set: all participants who took the study drug at least once.
| Characteristic | Unit | Lansoprazole 15 mg |
|---|---|---|
| Participants analysed | 3302 | |
| Age, Continuous | years | 67.9 (SD 14.21) |
| Sex: Female, Male: Female | Participants | 2268 |
| Sex: Female, Male: Male | Participants | 1034 |
| Purpose of Non-steroidal Anti-Inflammatory Drug (NSAID) Treatment: Rheumatoid arthritis | participants | 573 |
| Purpose of Non-steroidal Anti-Inflammatory Drug (NSAID) Treatment: Osteoarthritis | participants | 1729 |
| Purpose of Non-steroidal Anti-Inflammatory Drug (NSAID) Treatment: Other | participants | 1116 |
| Details of the History of Gastric or Duodenal Ulcers: Site of Disease: Gastric ulcer | participants | 2632 |
| Details of the History of Gastric or Duodenal Ulcers: Site of Disease: Gastroduodenal ulcer | participants | 207 |
| Details of the History of Gastric or Duodenal Ulcers: Site of Disease: Unknown | participants | 490 |
| Details of the History of Gastric or Duodenal Ulcers: Time of Emergence: <6 months before treatment | participants | 161 |
| Details of the History of Gastric or Duodenal Ulcers: Time of Emergence: ≥ 6 months to < 1 year before treatment | participants | 63 |
| Details of the History of Gastric or Duodenal Ulcers: Time of Emergence: ≥ 1 year before treatment | participants | 449 |
| Details of the History of Gastric or Duodenal Ulcers: Time of Emergence: Unknown | participants | 2629 |
| Presence or Absence of H. Pylori Infection: Negative | participants | 276 |
| Presence or Absence of H. Pylori Infection: Positive | participants | 55 |
| Presence or Absence of H. Pylori Infection: Unknown | participants | 2971 |
6. Primary Endpoint
The registry lists the primary outcome as Frequency of Adverse Drug Reactions, measured over 12 months.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is the frequency of adverse drug reactions, expressed as the number of participants for each adverse event. The registry says that frequency, severity, and time to onset were tabulated by symptom. Its definition of an adverse event includes an unfavorable and unintended sign, symptom, or disease temporally associated with use of a medicinal product, from the first dose through the last dose. An event considered possibly associated with a medicinal product is classified as an adverse drug reaction.
The endpoint is intended to describe observed safety events during exposure in the routine clinical setting. Counting participants for each event gives a direct description of how many people were recorded with each symptom or event; considering severity and time to onset adds information about the nature and timing of those events. The safety analysis set includes participants who received at least one dose, so it is an exposure-based population rather than all people listed as enrolled.
The registry record does not report the primary endpoint’s numerical result by event or symptom. The separate serious-event summary should not automatically be treated as the complete primary endpoint: serious adverse events and adverse drug reactions are not identical categories, because the latter depends on a judgment that an event was possibly associated with the medicinal product.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry describes a safety-focused surveillance study of lansoprazole 15 mg used for up to 12 months among people receiving oral NSAIDs. Its routine clinical setting is relevant to describing events recorded during use in that setting. However, the design has one listed treatment arm and no stated allocation method or comparator. The posted results therefore do not provide a randomized estimate of a treatment effect or a controlled estimate of excess risk.
The safety summary lists 3302 participants at risk, 50 participants affected in the serious category, and 0 in the other category. These counts describe the categories as posted; they do not establish that every listed event was an adverse drug reaction. The registry’s adverse drug reaction definition requires that an event be considered possibly associated with a medicinal product. The posted serious-event terms include Pancreatic carcinoma at 0.2%, and Colon cancer, Cardiac failure, Cellulitis, Pneumonia, and Hepatic cancer at 0.1% each. The registry record does not provide event-level details that would allow these listed terms to be assessed further.
No numerical result for the stated primary endpoint is reported in the registry record. In particular, the record does not give the number of participants with each adverse drug reaction, or the related severity and time-to-onset summaries described in the endpoint definition. The serious-event summary is not a substitute for those endpoint results. It also does not show whether particular events were judged possibly associated with lansoprazole.
Precision cannot be judged from a point estimate alone; a confidence interval, when reported, describes the range of values compatible with the data under the analysis assumptions. No confidence interval for the primary endpoint is reported in the registry record. Without that estimate and its uncertainty, the frequency of adverse drug reactions cannot be characterized precisely from the endpoint listing. Event counts for the separate serious category are descriptive, not a controlled comparison.
The study also lists outcomes involving ulcers, hemorrhagic lesions, endoscopic examinations, and their treatment. Numerical results for those secondary outcomes are not reported in the registry record. The record lists 0 statistical analysis entries, and does not state the analysis procedures used to produce the posted safety counts. Consequently, readers should interpret the available numbers as registry safety summaries, not as evidence of a comparative treatment effect or a complete account of all planned outcomes.
9. Statistical Methods Explained
The endpoint is a participant count for adverse drug reactions. In general, a binary outcome records whether each participant did or did not experience a specified event during the defined observation period. A count of participants with an event is interpretable only alongside a clearly defined population and follow-up period. Here, the endpoint description identifies the safety analysis set as all participants who received at least one dose and defines the event period from first dose to last dose. The registry does not report the event-specific primary endpoint counts.
What does a confidence interval communicate?
In general, a confidence interval expresses statistical uncertainty around an estimate under the assumptions of the method used. A narrow interval indicates more precision than a wide interval, while the interval’s placement also matters for interpretation. The registry record does not report a confidence interval for the primary endpoint. The serious-event counts therefore cannot be supplemented with an interval-based assessment of precision from the available record.
Why does the comparison structure matter?
In general, a controlled comparison helps separate an outcome associated with treatment from outcomes that may also occur because of the underlying condition, other medicines, or background risk. This record lists one intervention arm and does not state an allocation method. The registry notes that the arms are not a like-for-like control comparison. Therefore, the posted results can describe events recorded among participants in the surveillance study, but cannot estimate a treatment contrast against a randomized control group.
What is the role of the safety analysis set?
The safety analysis set includes participants who received at least one dose of the open-label study drug. This makes the population relevant to describing events during exposure, but the definition does not by itself establish complete follow-up for every participant. General statistical practice distinguishes an exposure-based safety population from populations defined by randomization or by completion of all planned assessments. The registry record does not report a separate analysis population for efficacy outcomes, a participant flow, or how incomplete observations were handled.
How should event categories be distinguished?
The registry defines adverse events broadly as unfavorable and unintended signs, symptoms, or diseases temporally associated with use of a medicinal product. An adverse drug reaction is a subset considered possibly associated with a medicinal product. In general, temporal association alone does not establish causation; assessment of relatedness is a separate judgment. Seriousness is another classification and does not, by itself, determine whether an event was caused by treatment. The serious-event summary should therefore be read separately from the primary endpoint definition.
What do the planning assumptions mean?
General sample-size planning estimates depend on the effect to be detected, the selected significance level, allocation, and statistical method. The planning illustrations associated with these results are described as using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. The target effect is described as a stated fraction of the observed effect. For time-to-event outcomes, the stated planning quantity is the total number of events; for other outcomes, it is participants per arm.
These are planning illustrations, not observed trial results and not observed power. They do not describe the study’s own design or establish that the surveillance study had two randomized arms. The record identifies one intervention arm and no like-for-like control comparison. The numerical planning results and the observed effect used for those illustrations are not reported in the registry record, so they cannot be interpreted or reconstructed from the stated assumptions alone.
What cannot be inferred from the analysis record?
The registry lists 0 statistical analysis entries. That does not identify which analytical procedures, if any, were used outside those registry entries. The record does not report a model for event counts, adjustment variables, confidence intervals, hypothesis tests, or handling of repeated events. For binary outcomes, general methods may compare event proportions or model the probability of an event, but the method must match the study design and data structure. No such analysis should be attributed to this study unless reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists the primary adverse drug reaction endpoint and secondary outcomes concerning endoscopic examinations, ulcers, hemorrhagic lesions, treatment, and treatment outcomes. Considering multiple outcomes raises a general multiplicity issue: when many statistical tests are performed, the chance of at least one apparently notable result can increase. A prespecified strategy may address this, but the registry record does not report a multiplicity adjustment, a hierarchy among secondary outcomes, or a statistical testing plan. It also lists 0 statistical analysis entries.
The primary endpoint is defined for the safety analysis set, which includes participants who received at least one dose. The registry record does not report how many participants had complete follow-up, how many stopped treatment early, or whether all participants had the same observation time. It does not describe methods for handling missing event information, incomplete assessments, or loss to follow-up. Missing-data procedures are not reported in the registry record.
The enrollment is listed as 3502, while the safety summary lists 3302 participants at risk. These are distinct reported figures, and the record does not explain participant flow between them. It does not give reasons for exclusion from the safety analysis set or report other analysis populations. No assumptions about missingness, imputation, or the treatment of participants without complete follow-up can be inferred from the available information.
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 |
|---|---|---|---|
| Lansoprazole 15 mg | 50 | 3302 | 1.5% |
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 |
|---|---|
| Lansoprazole 15 mg | 0 of 3302 |
Most frequent serious adverse event terms
| Event term | Organ system | Lansoprazole 15 mg |
|---|---|---|
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 8 of 3302 |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 3 of 3302 |
| Cardiac failure | Cardiac disorders | 3 of 3302 |
| Cellulitis | Infections and infestations | 2 of 3302 |
| Pneumonia | Infections and infestations | 2 of 3302 |
| Hepatic cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 2 of 3302 |
| Cerebral infarction | Nervous system disorders | 2 of 3302 |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | 2 of 3302 |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | 2 of 3302 |
| General physical health deterioration | General disorders | 2 of 3302 |
Serious events with the highest arm-level rate: pancreatic carcinoma (0.2%), colon cancer (0.1%), cardiac failure (0.1%), cellulitis (0.1%), pneumonia (0.1%).
The posted safety summary lists 3302 participants at risk, with 50 participants affected in the serious category and 0 in the other category. These are counts for the posted categories; they should not be read as a complete numerical report of the primary adverse drug reaction endpoint. The registry defines an adverse drug reaction by whether an event was considered possibly associated with a medicinal product, and the serious-event listing does not provide that relatedness judgment for each event.
The serious terms listed are Pancreatic carcinoma at 0.2%, and Colon cancer, Cardiac failure, Cellulitis, Pneumonia, and Hepatic cancer at 0.1% each. The registry record does not report the event-level narratives or explain how these terms were classified for seriousness or relatedness. In general, an event’s seriousness and its possible relationship to a medicine are different questions. The listed percentages are registry values and should not be treated as causal estimates or compared with an unstated background rate.
Deaths are not reported in the registry record. The summary also does not provide confidence intervals or details about follow-up duration for each participant, which limits interpretation of the precision and exposure context of the counts.
12. What the Result Does, and Does Not, Mean
The results describe safety events recorded in a completed routine-clinical-setting surveillance study of lansoprazole 15 mg used for up to 12 months by people receiving oral NSAIDs. They offer descriptive information about the study’s posted safety categories and the serious-event terms listed by the registry. They do not establish that lansoprazole caused any particular event, because the serious-event summary does not report event-specific relatedness judgments.
The record does not report a numerical result for the primary endpoint, which is the frequency of adverse drug reactions by event. It also does not report numerical results for the listed secondary outcomes. The reported serious-event counts cannot fill that gap: the endpoint’s adverse drug reaction category requires an assessment of possible association, whereas the serious-event summary is a distinct safety classification.
Because no comparator arm or allocation method is reported, these data cannot show how event frequencies differ from those under another treatment or no treatment. In general, events observed during treatment may also reflect the underlying condition, other exposures, or background occurrence. A single-arm description does not separate those explanations. The study also cannot, from the posted numbers alone, establish a comparative effect on ulcer recurrence or hemorrhagic lesions.
The registry record identifies the study as completed and reports enrollment and a safety population, but does not describe participant flow, missing-data handling, or uncertainty estimates for the endpoint. These omissions mean that the precision and completeness of the safety picture cannot be evaluated from the primary endpoint description. The findings should be understood as limited registry-reported surveillance information, not as proof of benefit, lack of harm, or a comparative treatment conclusion.
13. Why This Trial Matters Statistically
Long-term use in a routine clinical setting raises statistical questions that differ from those in a randomized comparison. Safety surveillance can describe events recorded among people exposed to a medicine, and the endpoint definition makes clear that the study considered frequency, severity, and time to onset. Such descriptions can be useful when considering the range of events monitored during extended use, provided the event definitions and analysis population are kept in view.
This record also illustrates why endpoint labels and results need to be distinguished. The primary endpoint is adverse drug reactions, which require an event to be considered possibly associated with the medicinal product. The posted serious-event categories are not automatically equivalent to that endpoint. Without event-specific primary results and relatedness information, the available counts cannot answer the primary question as fully as the endpoint definition implies.
The single-arm structure is also important. Descriptive event frequencies do not provide the counterfactual comparison needed to estimate what would have happened under a different treatment strategy. That limitation is especially relevant when interpreting events that may occur in the underlying population regardless of treatment. The record’s planning assumptions also illustrate that sample-size calculations are tied to a particular comparison and are not observed power or evidence of a treatment effect.
Statistically, the study highlights the value of transparent reporting of participant flow, follow-up, missing-data handling, analysis methods, and uncertainty. Those details would help readers judge how complete and precise an event-frequency estimate is. The registry record does not report them for the primary endpoint, so interpretation must remain descriptive and cautious.
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 main limitation is the absence of a reported comparator and allocation method. The registry identifies one intervention arm and notes that there is no like-for-like control comparison. The results therefore cannot support a randomized estimate of relative safety or efficacy.
The primary endpoint is described, but its numerical result is not reported in the registry record. The serious-event counts do not resolve this because the registry distinguishes adverse drug reactions by possible association with a medicinal product. Event-specific relatedness, severity, and time-to-onset results are not reported. Deaths are not reported in the registry record.
Participant flow is also unclear. Enrollment is listed as 3502 and the safety summary lists 3302 participants at risk, but the record does not explain the transition between these figures. Follow-up completeness, treatment discontinuation, reasons for exclusion, and missing-data handling are not reported. The study allows treatment for up to 12 months, but the record does not describe individual exposure durations.
The registry lists secondary outcomes but does not report their numerical results or the analysis methods used. It lists 0 statistical analysis entries and does not report a multiplicity strategy, confidence intervals, or adjustment procedures. The serious-event terms and percentages are descriptive registry entries; without further event-level context or a comparator, they do not establish causation or comparative risk.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Long-term Use of Takepron on the Prevention of Recurrence of Gastric/Duodenal Ulcer in Patients Receiving Non-steroidal Anti-inflammatory Drugs — NCT02099708.
- Registry record last updated 2016-10-27; status last verified 2016-09.
- Results first posted 2015-10-09.
- 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
The registry record describes a completed routine-clinical-setting surveillance study of lansoprazole 15 mg in people receiving oral NSAIDs. The listed regimen was once daily for up to 12 months, using capsules or orally disintegrating tablets. Enrollment was 3502; the primary endpoint population was the safety analysis set of participants who received at least one dose.
The primary endpoint was the frequency of adverse drug reactions, defined as events considered possibly associated with a medicinal product. The record does not report a numerical primary endpoint result. Its safety summary lists 3302 participants at risk, 50 in the serious category, and 0 in the other category. A comparator, allocation method, statistical analysis plan, missing-data procedures, and primary endpoint uncertainty estimates are not reported in the registry record.