Comparison · NCT00217022-e1f9ac6d
Budesonide vs Placebo: Histologic Improvement in Post Treatment Colon Biopsies Compared to Baseline Biopsies
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. Budesonide vs Placebo: Histologic Improvement in Post Treatment Colon Biopsies Compared to Baseline Biopsies. Trial comparisons, record NCT00217022-e1f9ac6d. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00217022-e1f9ac6d
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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 | 0.875 | 0.529 | 0.978 | wilson | |
| Risk in group 2 | 0.333 | 0.0615 | 0.792 | wilson | |
| Risk difference, group 1 minus group 2 | 0.542 | -0.0331 | 0.832 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2.63 | 0.519 | 13.3 | log | |
| Odds ratio, group 1 over group 2 | 14 | 0.579 | 339 | log | |
| Number needed to treat, for one more participant with the outcome on Budesonide than on Placebo | 1.85 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Budesonide | 9 mg daily | 7 | 8 | OG000 |
| Group 2 | Placebo | three tablets daily | 1 | 3 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Histologic Improvement in Post Treatment Colon Biopsies Compared to Baseline Biopsies
- Description
The histopathology scoring system included epithelial damage, lamina propria cellularity and intraepithelial lymphocytosis, each scored on a four point scale (normal (0), mildly increased (1), moderately increased (2), severely increased (3)).
- Time frame
- Baseline (day 1 of study) and at eight weeks (approximately)
- Population
- Only 8 of the subjects on the budesonide arm returned for the biopsy, so only those subjects on that arm were analyzed for this outcome measure.
Source ClinicalTrials.gov
Trial
- Title
- Budesonide Versus Placebo for the Treatment of Lymphocytic Colitis
- NCT number
- NCT00217022
- Phases
- PHASE2, PHASE3
- Conditions
- Lymphocytic Colitis, Diarrhea
- Interventions
- Placebo, Budesonide
- Lead sponsor
- Mayo Clinic
- Results first posted
- 2012-04-12
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00217022?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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