NCT02392286

Corticosteroid Dosage for Crohn's Disease Flare

A Prospective, Randomized Trial Comparing the Efficacy of Body-weight Based Versus Fixed Corticosteroid Dosage on Remission in Patients With Moderate to Severe Crohn's Disease Flares

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Prospective randomized comparative effectiveness trial designed to compare fixed dosing and weight-based dosing of corticosteroids in patients with Crohn's disease flares.

Detailed description

* Determine if weight-based corticosteroid (1mg/kg daily) induces remission at a greater rate than fixed corticosteroid dosage. * Determine if weight-based corticosteroid is associated with greater rate of adverse events than fixed corticosteroid dosage.

Conditions

• Crohn's Disease
• Inflammatory Bowel Disease

Interventions

Type	Name	Description
DRUG	Corticosteroid	Subjects will receive prednisone orally; if intravenous corticosteroid required initially they will receive methylprednisolone for the first 3-4 days of therapy.

Timeline

• Start date: 2015-03-01
• Primary completion: 2016-12-19
• Completion: 2016-12-19
• First posted: 2015-03-18
• Last updated: 2021-08-09
• Results posted: 2020-01-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study