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

Exclusion Criteria

• •Concomitant corticosteroids, budesonide
• •Corticosteroids within 2 months
• •Cyclosporine, mycophenolate mofetil or experimental drugs during the last three months
• •Maintenance infliximab, or infliximab or other biologics in the preceding 3 months
• •If the severity of the flare has started to decrease spontaneously
• •Coexisting diagnosis of primary sclerosing cholangitis
• •Infectious diarrhea
• •Signs of intestinal obstruction or perforation
• •New fistulization as part of the acute flare or increased activity in chronic fistula(e) as part of the acute flare
• •Hypersensitivity to 4-ASA or any components of PASER®
• •Pregnancy or breast-feeding
• •Failure of a woman of child-bearing potential to agree to use adequate contraception for the 4 week period of the trial, if sexually active
• •Severe renal or hepatic disease (i.e., more than 3 times upper limit of normal) or a WBC \< 3,000 during the preceding three months