drugset / Trial / NCT00495521

High Dose Oral 4-Aminosalicylic Acid (PASER®) to Control Acute Flares of Mild to Moderate Crohn's Disease in Children

NCT00495521 ↗

Phase 2 Terminated 2 enrolled Jacobus Pharmaceutical
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this 4 week study is to determine whether PASER®, an approved delayed-release oral formulation of 4-aminosalicylic acid, in doses of 50 milligrams per kilogram three times daily for 2 weeks followed by 50 milligrams per kilogram twice daily for 2 weeks, will resolve an acute flare of ileocecal Crohn's disease.

Timeline

Start
2007-06
Primary completion
2008-07
Completion
2008-10

Outcome

Outcome not reported

Stopped (Enrollment): “Efforts at recruitment have halted as recruitment was poor”

Drugs

EvaluationDrugModalityDoseRoute
Subject 4-Aminosalicylic acid Unknown 50 mg/kg Oral

Indications