Aminosalicylic Acid Withdrawal Study in Long Standing Inactive Ulcerative Colitis

Chinese University of Hong Kong177 enrolled

Overview

The purpose of this study is to determine whether aminosalicylic acid (ASA) can be safely withdrawn in patients with long-standing clinical inactive UC.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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

177

Conditions

Colitis, Ulcerative Aminosalicylic Acid

Interventions

MesalazineDRUG

Patients will be prescribed Asacol 2g daily for 12 months

Placebo oral capsuleDRUG

Patients will be prescribed placebo 5 capsules daily for 12 months

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Prince of Wales Hospital

Hong Kong, Hong Kong

Outcomes

Primary Outcomes

The differences of relapse rates between the two arms

Relapse rate of patient in both arms will be calculated

Time frame: 12 months

Secondary Outcomes

Patients' drug compliance

Proportion of patients with good drug compliance, defined as more than 80% of drug taken will be evaluated.

Time frame: 12 months

Data from ClinicalTrials.gov

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