Comparison · NCT00141102-16041040
Celecoxib vs Oral Diclofenac Plus Omeprazole: Number of Subjects With Clinically Significant Upper and/or Lower Gastrointestinal Events (CSULGIEs)
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. Celecoxib vs Oral Diclofenac Plus Omeprazole: Number of Subjects With Clinically Significant Upper and/or Lower Gastrointestinal Events (CSULGIEs). Trial comparisons, record NCT00141102-16041040. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00141102-16041040
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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 | 0.00894 | 0.00579 | 0.0138 | wilson | |
| Risk in group 2 | 0.0361 | 0.0291 | 0.0446 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0271 | -0.0362 | -0.0187 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.248 | 0.152 | 0.403 | log | |
| Odds ratio, group 1 over group 2 | 0.241 | 0.147 | 0.395 | log | |
| Number needed to treat, for one fewer participant with the outcome on Celecoxib than on Oral Diclofenac Plus Omeprazole | 36.9 | 27.6 | 53.6 | 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 | Celecoxib | 200 mg BID plus omeprazole placebo and diclofenac SR placebo | 20 | 2,238 | OG000 |
| Group 2 | Oral Diclofenac Plus Omeprazole | Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily \[QD\]) and celecoxib placebo. | 81 | 2,246 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Subjects With Clinically Significant Upper and/or Lower Gastrointestinal Events (CSULGIEs)
- Description
CSULGIE=any of the following: gastroduodenal (GD) hemorrhage; gastric outlet obstruction; GD, small or large bowel perforation; small or large bowel hemorrhage; clinically significant anemia of defined GI origin; acute GI hemorrhage of unknown origin, including presumed small bowel hemorrhage; clinically significant anemia of presumed occult GI origin including possible small bowel blood loss. Subjects were assessed by an independent GI Events Adjudication Committee, who were blinded to study treatment assignments.
- Time frame
- 6 month treatment duration
- Population
- Intent-to-Treat (ITT) = included all randomized subjects. n = number of subjects with events confirmed by the committee.
Source ClinicalTrials.gov
Trial
- Title
- Study Of Celecoxib Or Diclofenac And Omeprazole For Gastrointestinal (GI) Safety In High GI Risk Patients With Arthritis
- NCT number
- NCT00141102
- Phases
- PHASE4
- Conditions
- Osteoarthritis, Arthritis, Rheumatoid
- Interventions
- Celecoxib, Diclofenac + Omeprazole
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Results first posted
- 2010-06-11
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00141102?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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