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Comparison · NCT00059202-1bdcedeb

Ursodeoxycholic Acid vs Placebo: Number of Participants With Treatment Failure

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. Ursodeoxycholic Acid vs Placebo: Number of Participants With Treatment Failure. Trial comparisons, record NCT00059202-1bdcedeb. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00059202-1bdcedeb

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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 10.3950.2920.507wilson
Risk in group 20.2570.1710.367wilson
Risk difference, group 1 minus group 20.138-0.01210.279newcombe hybrid score
Risk ratio, group 1 over group 21.540.9542.48log
Odds ratio, group 1 over group 21.890.9423.78log
Number needed to treat, for one more participant with the outcome on Ursodeoxycholic Acid than on Placebo7.25from the risk difference intervalthe interval includes no difference

Groups2

Group 2 names the comparator: placebo.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Ursodeoxycholic AcidUrsodeoxycholic Acid 28-30 mg/kg/day in divided doses3076OG000
Group 2PlaceboPlacebo for Urso1974OG001

Outcome

Type
PRIMARY
Title
Number of Participants With Treatment Failure
Description
Treatment failure was defined as death, transplantation, meeting minimal listing criteria, development of varices, cholangiocarcinoma, or progression to cirrhosis
Time frame
5 years
Population

Source ClinicalTrials.gov

Trial

Title
Trial of High-dose Urso in Primary Sclerosing Cholangitis
NCT number
NCT00059202
Phases
PHASE2, PHASE3
Conditions
Primary Sclerosing Cholangitis
Interventions
Ursodeoxycholic Acid, Placebo
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Results first posted
2021-04-08

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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