Aminosalicylic Acid Withdrawal Study in Long Standing Inactive Ulcerative Colitis

The Chinese University of Hong Kong

Status: Completed

Conditions: Colitis, Ulcerative; Aminosalicylic Acid

Treatments: Drug: Placebo oral capsule; Drug: Mesalazine

Study type: Interventional

Funder types: Other

Identifiers

NCT02537210

ASA withdrawal study

Details and patient eligibility

About

The purpose of this study is to determine whether aminosalicylic acid (ASA) can be safely withdrawn in patients with long-standing clinical inactive UC.

Full description

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.

Enrollment: 177 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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177 participants in 2 patient groups, including a placebo group

Mesalazine

Active Comparator group

Description:

mesalazine 2g od po for 12 months

Treatment:

Drug: Mesalazine

Placebo oral capsule

Placebo Comparator group

Description:

placebo 5 capsules od po for 12 months

Treatment:

Drug: Placebo oral capsule