drugset / Trial / NCT00417690

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

NCT00417690 ↗

Phase 2 Terminated 54 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 4 grams three times daily for 2 weeks followed by 4 grams twice daily for 2 weeks, will resolve an acute flare of ileocecal Crohn's disease.

Timeline

Start
2007-01
Primary completion
2007-12
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 4 g Oral

Indications