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Comparison · NCT01903252-e67207c3

TP05 (Mesalazine) vs Asacol (Mesalazine): Period 1: Clinical and Endoscopic Response

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. TP05 (Mesalazine) vs Asacol (Mesalazine): Period 1: Clinical and Endoscopic Response. Trial comparisons, record NCT01903252-e67207c3. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01903252-e67207c3

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 10.570.520.618wilson
Risk in group 20.6110.5620.659wilson
Risk difference, group 1 minus group 2-0.0418-0.110.0274newcombe hybrid score
Risk ratio, group 1 over group 20.9320.8281.05log
Odds ratio, group 1 over group 20.8410.6311.12log
Number needed to treat, for one fewer participant with the outcome on TP05 (Mesalazine) than on Asacol (Mesalazine)23.9from the risk difference intervalthe interval includes no difference

Groups2

Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1TP05 (Mesalazine)3.2g/day once daily at week 8221388OG000
Group 2Asacol (Mesalazine)3.2g/d twice daily at week 8236386OG001

Outcome

Type
SECONDARY
Title
Period 1: Clinical and Endoscopic Response
Description
Clinical and Endoscopic Response was defined as a decrease in the Mayo score of ≥3 points from baseline and a reduction of ≥ 30% from baseline with either an accompanying decrease in the rectal bleeding sub-score of at least 1 point or an absolute rectal bleeding sub-score of 0 or 1 at the Week 8 visit. If a subject withdrew from the study prior to Week 8 or their response status was not evaluable due to incomplete and/or invalid data, the subject was considered a non-responder.
Time frame
Week 8
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

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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