Aminosalicylic Acid Withdrawal Study in Long Standing Inactive Ulcerative Colitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

177 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2021-09-10

Brief Summary

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The purpose of this study is to determine whether aminosalicylic acid (ASA) can be safely withdrawn in patients with long-standing clinical inactive UC.

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Detailed Description

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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.

Conditions

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Colitis, Ulcerative Aminosalicylic Acid

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Mesalazine

mesalazine 2g od po for 12 months

Group Type ACTIVE_COMPARATOR

Mesalazine

Intervention Type DRUG

Patients will be prescribed Asacol 2g daily for 12 months

Placebo oral capsule

placebo 5 capsules od po for 12 months

Group Type PLACEBO_COMPARATOR

Placebo oral capsule

Intervention Type DRUG

Patients will be prescribed placebo 5 capsules daily for 12 months

Interventions

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Mesalazine

Patients will be prescribed Asacol 2g daily for 12 months

Intervention Type DRUG

Placebo oral capsule

Patients will be prescribed placebo 5 capsules daily for 12 months

Intervention Type DRUG

Other Intervention Names

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Asacol Placebo

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No