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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02537210

Enrollment

177

Registered

2015-09-01

Start date

2015-09-30

Completion date

2021-09-10

Last updated

2023-05-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aminosalicylic Acid, Colitis, Ulcerative

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The purpose of this study is to determine whether aminosalicylic acid (ASA) can be safely withdrawn in patients with long-standing clinical inactive UC.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

Interventions

DRUGMesalazine

Patients will be prescribed Asacol 2g daily for 12 months

DRUGPlacebo oral capsule

Patients will be prescribed placebo 5 capsules daily for 12 months

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

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

Countries

Hong Kong

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026