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

• 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 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.

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

Details

• Lead Sponsor: Jacobus Pharmaceutical
• Treatments: Aminosalicylic Acid

Criteria

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