Comparison · NCT01903252-90a30afb
TP05 (Mesalazine) vs Asacol (Mesalazine, Tillotts Pharma AG): Period 1: Clinical Response at Both Week 8 and Week 12
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. TP05 (Mesalazine) vs Asacol (Mesalazine, Tillotts Pharma AG): Period 1: Clinical Response at Both Week 8 and Week 12. Trial comparisons, record NCT01903252-90a30afb. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01903252-90a30afb
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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 | 0.557 | 0.507 | 0.605 | wilson | |
| Risk in group 2 | 0.596 | 0.546 | 0.644 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0392 | -0.108 | 0.0304 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.934 | 0.828 | 1.05 | log | |
| Odds ratio, group 1 over group 2 | 0.852 | 0.64 | 1.13 | log | |
| Number needed to treat, for one fewer participant with the outcome on TP05 (Mesalazine) than on Asacol (Mesalazine, Tillotts Pharma AG) | 25.5 | from the risk difference interval | the interval includes no difference |
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 | TP05 (Mesalazine) | 3.2g/day once daily for 12 weeks (blinded) | 216 | 388 | OG000 |
| Group 2 | Asacol (Mesalazine, Tillotts Pharma AG) | 3.2g/d twice daily for 12 weeks (blinded) | 230 | 386 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Period 1: Clinical Response at Both Week 8 and Week 12
- Description
- A decrease in the Partial Mayo Score of ≥ 2 points and ≥ 30% from baseline, with a decrease in the rectal bleeding sub-score of ≥ 1 point or absolute rectal bleeding sub-score of 1 or 0.
- Time frame
- Week 8 and Week 12
- Population
- Per Protocol
Source ClinicalTrials.gov
Trial
- Title
- TP05 for the Treatment of Mild to Moderate Active Ulcerative Colitis (UC)
- NCT number
- NCT01903252
- Phases
- PHASE3
- Conditions
- Acute Ulcerative Colitis
- Interventions
- TP05, Asacol 400 mg
- Lead sponsor
- Tillotts Pharma AG
- Results first posted
- 2018-08-08
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01903252?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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