Aminosalicylic Acid Withdrawal Study in Long Standing Inactive Ulcerative Colitis

May 30, 2023 updated by: Siew Chien NG, Chinese University of Hong Kong

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

The purpose of this study is to determine whether aminosalicylic acid (ASA) can be safely withdrawn in patients with long-standing clinical inactive UC.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

177

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong, 0000
        • Prince of Wales Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Mesalazine
mesalazine 2g od po for 12 months
Drug: Mesalazine
Patients will be prescribed Asacol 2g daily for 12 months
Other Names:
  • Asacol
Placebo Comparator: Placebo oral capsule
placebo 5 capsules od po for 12 months
Drug: Placebo oral capsule
Patients will be prescribed placebo 5 capsules daily for 12 months
Other Names:
  • Placebo

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Collaborators

Queen Elizabeth Hospital, Hong Kong
Alice Ho Miu Ling Nethersole Hospital
Tseung Kwan O Hospital, Hong Kong

Investigators

  • Principal Investigator: Siew Ng, PhD, Chinese University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2015

Primary Completion (Actual)

September 10, 2021

Study Completion (Actual)

September 10, 2021

Study Registration Dates

First Submitted

August 28, 2015

First Submitted That Met QC Criteria

August 29, 2015

First Posted (Estimated)

September 1, 2015

Study Record Updates

Last Update Posted (Actual)

May 31, 2023

Last Update Submitted That Met QC Criteria

May 30, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ASA withdrawal study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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