Efficacy Study of Targeted, Local Delivery of Drugs to Treat Crohn's Disease
Status:
Completed
Trial end date:
2007-12-01
Target enrollment:
Participant gender:
Summary
The study is being undertaken to evaluate whether delayed-release medications, designed to
begin to open in the lower intestinal tract, the main site of Crohn's Disease, are more
effective than standard systemically delivered drugs to promote remission or response in CD
patients. It is hypothesized that the delayed-release medications will go right to the
injured tissue and heal the disease more quickly.
The delayed-release test drugs are 6-mercaptopurine (at a dose of 40 mg daily) or calcitriol
(at a dose of 5 mcg three times a week) versus Purinethol (6-MP at a dose of 1-2 mg/kg body
weight daily). Calcitriol is a synthetically manufactured replica of a natural substance in
the body that is derived from Vitamin D. There is much medical evidence that shows that lack
of Vitamin D can be a possible risk factor in developing autoimmune disorders, including
Crohn's Disease. Moreover, calcitriol has been shown in animal models to improve the symptoms
of Crohn's Disease.