Aminosalicylic Acid Withdrawal Study in Long Standing Inactive Ulcerative Colitis

NCT02537210 | Completed

• 1 other identifier: ASA withdrawal study
• Study Type: interventional
• Target: 177
• Locations: 1 country
• Sites: 1

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The purpose of this study is to determine whether aminosalicylic acid (ASA) can be safely withdrawn in patients with long-standing clinical inactive UC.

Conditions

Colitis, Ulcerative; Aminosalicylic Acid

Outcome Measures

Primary Outcomes (1)

• The differences of relapse rates between the two arms

  Relapse rate of patient in both arms will be calculated

  12 months

Secondary Outcomes (1)

• Patients' drug compliance

  12 months

Study Arms (2)

Mesalazine

ACTIVE COMPARATOR

mesalazine 2g od po for 12 months

Drug: Mesalazine

Placebo oral capsule

PLACEBO COMPARATOR

placebo 5 capsules od po for 12 months

Drug: Placebo oral capsule

Interventions

Mesalazine DRUG

Patients will be prescribed Asacol 2g daily for 12 months

Also known as: Asacol

Mesalazine

Placebo oral capsule DRUG

Patients will be prescribed placebo 5 capsules daily for 12 months

Also known as: Placebo

Placebo oral capsule

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• have a confirmed diagnosis of UC according to established clinical, endoscopic and histologic criteria
• in long-standing clinical remission
• written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead
• Queen Elizabeth Hospital, Hong Kong: collaborator
• Alice Ho Miu Ling Nethersole Hospital: collaborator
• Tseung Kwan O Hospital, Hong Kong: collaborator

Study Sites (1)

Prince of Wales Hospital

Hong Kong, 0000, Hong Kong

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Mesalamine

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

meta-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Aminosalicylic Acids; Salicylates; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols

Study Officials

• Siew Ng, PhD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 28, 2015
• First Posted: September 1, 2015
• Study Start: September 1, 2015
• Primary Completion: September 10, 2021
• Study Completion: September 10, 2021
• Last Updated: May 31, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)