Comparison · NCT00450658-9e2cfcce
HZT-501 vs Ibuprofen: Number of Subjects Who Develop Endoscopically-diagnosed Upper Gastrointestinal Ulcers Confirmed by Endoscopy.
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. HZT-501 vs Ibuprofen: Number of Subjects Who Develop Endoscopically-diagnosed Upper Gastrointestinal Ulcers Confirmed by Endoscopy. Trial comparisons, record NCT00450658-9e2cfcce. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00450658-9e2cfcce
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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 | 0.105 | 0.0783 | 0.14 | wilson | |
| Risk in group 2 | 0.2 | 0.149 | 0.263 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0947 | -0.163 | -0.0332 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.526 | 0.35 | 0.792 | log | |
| Odds ratio, group 1 over group 2 | 0.471 | 0.29 | 0.763 | log | |
| Number needed to treat, for one fewer participant with the outcome on HZT-501 than on Ibuprofen | 10.6 | 6.14 | 30.1 | 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 | HZT-501 | HZT-501: Ibuprofen 800mg/Famotidine 26.6mg | 40 | 380 | OG000 |
| Group 2 | Ibuprofen | Ibuprofen 800mg | 38 | 190 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Subjects Who Develop Endoscopically-diagnosed Upper Gastrointestinal Ulcers Confirmed by Endoscopy.
- Description
The primary efficacy endpoint was the number of subjects with upper gastrointestinal (i.e., gastric and/or duodenal) ulcer at any time throughout 24 weeks of treatment. An ulcer was defined as a mucosal break of at least 3 mm in diameter with unequivocal depth. A subject is considered to have completed the study if all scheduled assessments up through the Week 24 visit have been performed.
- Time frame
- 24 weeks
- Population
- All randomized subjects who received at least one dose of study drug and who underwent a baseline endoscopic examination and at least the Week 8 endoscopic examination.
Source ClinicalTrials.gov
Trial
- Title
- Efficacy and Safety Study of HZT-501 in Reducing the Risk of Ibuprofen-associated Ulcers
- NCT number
- NCT00450658
- Phases
- PHASE3
- Conditions
- Peptic Ulcer
- Interventions
- HZT-501, Ibuprofen
- Lead sponsor
- Amgen
- Results first posted
- 2011-06-21
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00450658?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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