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Clinical Trial Summary

OBJECTIVES:

I. Assess the efficacy and safety of 4-aminosalicylic acid in patients with active Crohn's disease of the small bowel.


Clinical Trial Description

PROTOCOL OUTLINE: This is a randomized, placebo controlled, multicenter study. Patients are randomized to receive either oral 4-aminosalicylic acid (4-ASA) or placebo twice a day for 12 weeks. After 12 weeks patients who improved with 4-ASA and those who received placebo are given the option of receiving 4-ASA for an additional year.

Patients who were randomized to receive 4-ASA and continue treatment after 12 weeks are followed every 3 months for 1 year. Patients who were randomized to receive placebo and begin 4-ASA therapy after 12 weeks are followed monthly for 3 months, then every 3 months for 1 year.

Completion date provided represents the completion date of the grant per OOPD records ;


Study Design

Allocation: Randomized, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00004423
Study type Interventional
Source FDA Office of Orphan Products Development
Contact
Status Completed
Phase N/A
Start date December 1995
Completion date March 1998

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