Comparison · NCT00960869-d91cfc3f
PA32540 vs EC-Aspirin 325 mg: The Number of Participants With Heartburn Resolution at 6 Months, i.e. no Heartburn Symptoms During the Last 7 Days Prior to the Visit
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. PA32540 vs EC-Aspirin 325 mg: The Number of Participants With Heartburn Resolution at 6 Months, i.e. no Heartburn Symptoms During the Last 7 Days Prior to the Visit. Trial comparisons, record NCT00960869-d91cfc3f. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00960869-d91cfc3f
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.772 | 0.717 | 0.819 | wilson | |
| Risk in group 2 | 0.585 | 0.524 | 0.643 | wilson | |
| Risk difference, group 1 minus group 2 | 0.188 | 0.108 | 0.264 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.32 | 1.17 | 1.49 | log | |
| Odds ratio, group 1 over group 2 | 2.41 | 1.65 | 3.53 | log | |
| Number needed to treat, for one more participant with the outcome on PA32540 than on EC-Aspirin 325 mg | 5.33 | 3.78 | 9.29 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | PA32540 | PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole dosed once daily (QD) | 200 | 259 | OG000 |
| Group 2 | EC-Aspirin 325 mg | EC-Aspirin 325 mg enteric coated tablet (PA32540 minus omeprazole) dosed once daily (QD) | 152 | 260 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- The Number of Participants With Heartburn Resolution at 6 Months, i.e. no Heartburn Symptoms During the Last 7 Days Prior to the Visit
- Description
Subjects were asked whether heartburn symptoms within the 7 days prior to the visit were:~* none: no symptoms~* mild: awareness of symptom, but easily tolerated~* moderate: discomforting symptom sufficient to cause interference with normal activities (including sleep)~* severe: incapacitating symptom, with inability to perform normal activities (including sleep) Heartburn was defined as a burning feeling rising from the stomach or lower part of the chest towards the neck.
- Time frame
- 6 months
- Population
- Intent to Treat (ITT) Population
Source ClinicalTrials.gov
Trial
- Title
- Study to Evaluate the Incidence of Gastric Ulcers Following Administration of Either PA32540 or Enteric Coated Aspirin 325 mg in Subjects Who Are at Risk for Developing Aspirin-Associated Ulcers
- NCT number
- NCT00960869
- Phases
- PHASE3
- Conditions
- Gastric Ulcer
- Interventions
- PA32540, EC-Aspirin 325 mg
- Lead sponsor
- POZEN
- Results first posted
- 2016-02-17
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00960869?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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