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

PHASE2TerminatedINTERVENTIONAL
Enrollment

2

Participants

Timeline

Start Date

June 30, 2007

Primary Completion Date

July 31, 2008

Study Completion Date

October 31, 2008

Conditions
Crohn's Disease
Interventions
DRUG

4-Aminosalicylic acid extended release granules

Granules for oral administration will be administered as a volume equivalent to 50 mg/kg of 4-aminosalicylic acid three times daily for 2 weeks followed by 2 times daily for 2 weeks in the active arm or a comparable volume in the placebo arm

Trial Locations (5)

30342

Children's Center for Digestive HealthCare, LLC, Atlanta

77030

Texas Children's Hospital, Baylor College of Medicine, Houston

90048

Cedars-Sinai Medical Center, Los Angeles

94143-0316

University of California, San Francisco, San Francisco

07962

Atlantic Health System / Morristown Memorial Hospital / Goryeb Children's Hospital, Morristown

Sponsors
All Listed Sponsors
lead

Jacobus Pharmaceutical

INDUSTRY