Aminosalicylic Acid Withdrawal Study in Long Standing Inactive Ulcerative Colitis

Oral 5-aminosalicylic Acid Withdrawal in Long Standing Inactive Ulcerative Colitis: A Double-blind, Randomized, Placebo-controlled Trial

The purpose of this study is to determine whether aminosalicylic acid (ASA) can be safely withdrawn in patients with long-standing clinical inactive UC.

This is a randomized, double-blind, controlled trial in which patients with long-standing clinically inactive UC receiving ASA for maintenance of remission will be randomized to either continue 5-ASA or to receive an equivalent placebo for 12 months. The primary endpoint is clinical relapse at 12 months.

Inclusion Criteria:

• have a confirmed diagnosis of UC according to established clinical, endoscopic and histologic criteria
• in long-standing clinical remission
• written informed consent

Exclusion Criteria:

• allergic to mesalazine
• prior bowel surgery except appendectomy
• hepatic or renal dysfunction
• malignant disease within 5 years
• pregnancy or breast feeding or women of child-bearing age without regular use of contraception
• on anti-tumor necrosis factor therapy
• terminal illness