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NCT02537210 Clinical Trial

Aminosalicylic Acid Withdrawal Study in Long Standing Inactive Ulcerative Colitis

Colitis, Ulcerative Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02537210
Other study ID # ASA withdrawal study
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 2015
Est. completion date September 10, 2021

Study information
Verified date May 2023
Source Chinese University of Hong Kong
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

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The purpose of this study is to determine whether aminosalicylic acid (ASA) can be safely withdrawn in patients with long-standing clinical inactive UC.

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.

Recruitment information / eligibility
Status Completed
Enrollment 177
Est. completion date September 10, 2021
Est. primary completion date September 10, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Mesalazine
Patients will be prescribed Asacol 2g daily for 12 months
• Placebo oral capsule
Patients will be prescribed placebo 5 capsules daily for 12 months

Locations
Country Name City State
Hong Kong Prince of Wales Hospital Hong Kong

Sponsors (4)
Lead Sponsor Collaborator
Chinese University of Hong Kong Alice Ho Miu Ling Nethersole Hospital, Queen Elizabeth Hospital, Hong Kong, Tseung Kwan O Hospital, Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome
Type Measure Description Time frame Safety issue
Primary The differences of relapse rates between the two arms Relapse rate of patient in both arms will be calculated 12 months
Secondary Patients' drug compliance Proportion of patients with good drug compliance, defined as more than 80% of drug taken will be evaluated. 12 months
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