Skip to main content
OpenTrials
Completed

NCT Number: NCT02537210

Aminosalicylic Acid Withdrawal Study in Long Standing Inactive Ulcerative Colitis

The purpose of this study is to determine whether aminosalicylic acid (ASA) can be safely withdrawn in patients with long-standing clinical inactive UC.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Colitis, Ulcerative Aminosalicylic Acid Colitis Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Prince of Wales Hospital

Hong Kong, 0000

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mesalazine

Drug

Patients will be prescribed Asacol 2g daily for 12 months

Other names: Asacol

Placebo oral capsule

Drug

Patients will be prescribed placebo 5 capsules daily for 12 months

Other names: Placebo

Primary outcomes

  1. The differences of relapse rates between the two arms

    Time frame: 12 months

    Relapse rate of patient in both arms will be calculated

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2021
Study completion
2021
First posted
Sep 1, 2015
Registry last updated
May 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.