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

• Status: Terminated
• Trial end date: 2008-10-01
• Target enrollment: 0
• Participant gender: All

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 50 milligrams per kilogram three times daily for 2 weeks followed by 50 milligrams per kilogram twice daily for 2 weeks, will resolve an acute flare of ileocecal Crohn's disease.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jacobus Pharmaceutical
• Treatments: Aminosalicylic Acid

Criteria

Inclusion Criteria:

• Age less than 18 years

• Crohn's disease predominantly involving 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, 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