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Aminosalicylic Acid Withdrawal Study in Long Standing Inactive Ulcerative Colitis

Primary Purpose

Colitis, Ulcerative, Aminosalicylic Acid

Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Mesalazine
Placebo oral capsule
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colitis, Ulcerative

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Prince of Wales Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Mesalazine

Placebo oral capsule

Arm Description

mesalazine 2g od po for 12 months

placebo 5 capsules od po for 12 months

Outcomes

Primary Outcome Measures

The differences of relapse rates between the two arms
Relapse rate of patient in both arms will be calculated

Secondary Outcome Measures

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

Full Information

First Posted
August 28, 2015
Last Updated
May 30, 2023
Sponsor
Chinese University of Hong Kong
Collaborators
Queen Elizabeth Hospital, Hong Kong, Alice Ho Miu Ling Nethersole Hospital, Tseung Kwan O Hospital, Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT02537210
Brief Title
Aminosalicylic Acid Withdrawal Study in Long Standing Inactive Ulcerative Colitis
Official Title
Oral 5-aminosalicylic Acid Withdrawal in Long Standing Inactive Ulcerative Colitis: A Double-blind, Randomized, Placebo-controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
September 2015 (Actual)
Primary Completion Date
September 10, 2021 (Actual)
Study Completion Date
September 10, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
Collaborators
Queen Elizabeth Hospital, Hong Kong, Alice Ho Miu Ling Nethersole Hospital, Tseung Kwan O Hospital, Hong Kong

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colitis, Ulcerative, Aminosalicylic Acid

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
177 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mesalazine
Arm Type
Active Comparator
Arm Description
mesalazine 2g od po for 12 months
Arm Title
Placebo oral capsule
Arm Type
Placebo Comparator
Arm Description
placebo 5 capsules od po for 12 months
Intervention Type
Drug
Intervention Name(s)
Mesalazine
Other Intervention Name(s)
Asacol
Intervention Description
Patients will be prescribed Asacol 2g daily for 12 months
Intervention Type
Drug
Intervention Name(s)
Placebo oral capsule
Other Intervention Name(s)
Placebo
Intervention Description
Patients will be prescribed placebo 5 capsules daily for 12 months
Primary Outcome Measure Information:
Title
The differences of relapse rates between the two arms
Description
Relapse rate of patient in both arms will be calculated
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Patients' drug compliance
Description
Proportion of patients with good drug compliance, defined as more than 80% of drug taken will be evaluated.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Siew Ng, PhD
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prince of Wales Hospital
City
Hong Kong
ZIP/Postal Code
0000
Country
Hong Kong

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Aminosalicylic Acid Withdrawal Study in Long Standing Inactive Ulcerative Colitis

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