Aminosalicylic Acid Withdrawal Study in Long Standing Inactive Ulcerative Colitis

Not Applicable

Completed

• Conditions: Colitis, Ulcerative; Aminosalicylic Acid
• Interventions: Drug: Placebo oral capsule; Drug: Mesalazine

• Registration Number: NCT02537210
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

The purpose of this study is to determine whether aminosalicylic acid (ASA) can be safely withdrawn in patients with long-standing clinical inactive UC.

Detailed 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.

Study Timeline

• Study First Submitted: 2015-08-28
• Study First Submitted QC: 2015-08-29
• Study Start: 2015-09
• Study First Posted: 2015-09-01
• Primary Completion: 2021-09-10
• Study Completion: 2021-09-10
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-30
• Last Update Posted: 2023-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 177

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo oral capsule	Placebo oral capsule	placebo 5 capsules od po for 12 months
Mesalazine	Mesalazine	mesalazine 2g od po for 12 months

Primary Outcome Measures

Name	Time	Method
The differences of relapse rates between the two arms	12 months	Relapse rate of patient in both arms will be calculated

Secondary Outcome Measures

Name	Time	Method
Patients' drug compliance	12 months	Proportion of patients with good drug compliance, defined as more than 80% of drug taken will be evaluated.

Trial Locations

Locations (1)

Prince of Wales Hospital; 🇭🇰 Hong Kong, Hong Kong