NCT00004423

Controlled Trial of 4-Aminosalicylic Acid in Patients With Small Bowel Crohn's Disease

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (planned)
• Sponsor: University of Vermont · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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

Conditions

• Crohn's Disease

Interventions

Type	Name	Description
DRUG	-aminosalicylic acid

Timeline

• Start date: 1995-12-01
• Completion: 1998-03-01
• First posted: 1999-10-19
• Last updated: 2015-03-25