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

Inclusion Criteria: * Age 18-65 * Crohn's disease involving predominantly the ileum and/or cecum. The diagnosis must have been established by radiography, endoscopy and/or biopsy (at least 2 of the 3 modalities) with at least one confirmatory test having been performed no more than 36 months before entry. The diagnosis must have been confirmed by at least one gastroenterologist. * Harvey Bradshaw Index of at least 7 * The onset of the acute flare should have been abrupt, declaring itself over 72 hours, and should have started no more than 4 weeks before study entry. Symptoms relating to the flare should not have diminished or started to improve prior to entry. * Written informed consent Exclusion Criteria: * Concomitant corticosteroids, including budesonide * Corticosteroids within the previous 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 * Change in dose during previous 4 weeks in 5-aminosalicylate, probiotic and/or antibiotic, or in chronic azathioprine, 6-mercaptopurine, or methotrexate * If currently using azathioprine, 6-mercaptopurine or methotrexate, these must have been used steadily for at least 4 months * Current experimental drugs or experimental drugs within the last 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 or abscess, * New fistulization as part of the acute flare or increased activity in chronic fistula(e) as part of the acute flare, * Increased activity of pre-existing anal or rectal Crohn's disease as part of the flare * Allergy or sensitivity to salicylates * Pregnancy or breast-feeding * Failure of a woman of child-bearing age to agree to use adequate contraception for the 4 week period of the trial, if sexually active * Severe renal or hepatic disease