NCT00417690

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

A Prospective Randomized Double-Blind Study of PASER® in the Management of Patients Experiencing an Acute Flare of Crohn's Disease

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 54 (estimated)
• Sponsor: Jacobus Pharmaceutical · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Crohn's Disease

Interventions

Type	Name	Description
DRUG	4-Aminosalicylic acid	Oral granules administered as one 4 g packet three times daily for two weeks followed by one 4 g packet two times daily for two weeks
DRUG	PASER placebo granules	Oral granules administered administered as one packet three times daily for two weeks followed by one packet two times daily for two weeks

Timeline

• Start date: 2007-01-01
• Primary completion: 2007-12-01
• Completion: 2008-10-01
• First posted: 2007-01-04
• Last updated: 2008-10-15

Locations

5 sites across 2 countries: United States, Israel