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

Jacobus Pharmaceutical

Status and phase: Terminated; Phase 2

Conditions: Crohn's Disease

Treatments: Drug: 4-Aminosalicylic acid; Drug: PASER placebo granules

Study type: Interventional

Funder types: Industry

Identifiers

NCT00417690

PASER-AFC.001

Details and patient eligibility

About

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.

Enrollment: 54 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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54 participants in 2 patient groups, including a placebo group

A

Experimental group

Description:

Oral granules administered as one 4 g packet three times daily for two weeks followed by one 4 g packet two times daily for two weeks

Treatment:

Drug: 4-Aminosalicylic acid

P

Placebo Comparator group

Description:

One packet of oral granules administered three times daily for 2 weeks followed by one packet two times daily for two weeks

Treatment:

Drug: PASER placebo granules