drugset / Trial / NCT02922374

Ulcerative Colitis Endoscopic Index of Severity and Fecal Calprotectin to Predict the Reaction to Corticosteroids of Acute Severe Ulcerative Colitis

NCT02922374

Phase 1/2 Unknown 117 enrolled Jinling Hospital, China
NaSingle-groupOpen-labelTreatment

Summary

For acute severe colitis (ASC) patients, corticosteroids (CS) was recommended as the first-line treatment in the guideline, but patients have a great risk of requiring colectomy or turning to second-line treatment. This study aim to verify the effectiveness of ulcerative colitis endoscopic index of severity(UCEIS) in predicting the reaction to corticosteroids, and explores the possibility that noninvasive marker fecal calprotectin (FC) could act as an alternative to UCEIS.

Timeline

Start
2013-01
Primary completion
2016-06
Completion
2016-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Hydrocortisone Other / unclassified 400 mg Intravenous
Subject Methylprednisolone Other / unclassified 60 mg Intravenous

Indications