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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Crohn's Disease

In brief

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.

Key facts

Study ID

NCT00495521

Run by

Jacobus Pharmaceutical

People needed

2

Starts

2007-06-01

Expected to finish

2008-10-01

Last updated by the study team

2017-09-21

Who can join

Age: 2 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Cedars-Sinai Medical Center — Los Angeles, California, United States
• University of California, San Francisco — San Francisco, California, United States
• Children's Center for Digestive HealthCare, LLC — Atlanta, Georgia, United States
• Atlantic Health System / Morristown Memorial Hospital / Goryeb Children's Hospital — Morristown, New Jersey, United States
• Texas Children's Hospital, Baylor College of Medicine — Houston, Texas, United States

Full record on ClinicalTrials.gov

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