Crohn's Disease Clinical Trial
Official title:
A Prospective Randomized Double-Blind Study of PASER® in the Management of Patients Experiencing an Acute Flare of Crohn's Disease
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.
Eligible pediatric patients with acute flares of ileocecal Crohn's disease will be randomized
to receive either 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, or an identical-appearing placebo
preparation.
Patients will be required to maintain a daily diary and to return at 2 weeks for blood and
stool tests. At the four week mark, patients will return for clinical evaluation, global
assessment of disease activity and change in disease activity, as well as additional
laboratory tests.
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