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Aminosalicylic Acid Withdrawal Study in Long Standing Inactive Ulcerative Colitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02537210
Recruitment Status : Recruiting
First Posted : September 1, 2015
Last Update Posted : April 29, 2020
Sponsor:
Collaborators:
Queen Elizabeth Hospital, Hong Kong
Alice Ho Miu Ling Nethersole Hospital
Tseung Kwan O Hospital, Hong Kong
Information provided by (Responsible Party):
Siew Chien NG, Chinese University of Hong Kong

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The purpose of this study is to determine whether aminosalicylic acid (ASA) can be safely withdrawn in patients with long-standing clinical inactive UC.

Condition or disease Intervention/treatment Phase
Colitis, Ulcerative Aminosalicylic Acid Drug: Mesalazine Drug: Placebo oral capsule Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 194 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Oral 5-aminosalicylic Acid Withdrawal in Long Standing Inactive Ulcerative Colitis: A Double-blind, Randomized, Placebo-controlled Trial
Actual Study Start Date : September 2015
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : August 2022

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Placebo




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02537210


Contacts
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Contact: Siew Ng, PhD (852)26321519 siewchienng@cuhk.edu.hk

Locations
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Hong Kong
Prince of Wales Hospital Recruiting
Hong Kong, Hong Kong, 0000
Contact: Siew Ng    (852)35051519    siewchienng@cuhk.edu.hk   
Sponsors and Collaborators
Chinese University of Hong Kong
Queen Elizabeth Hospital, Hong Kong
Alice Ho Miu Ling Nethersole Hospital
Tseung Kwan O Hospital, Hong Kong
Investigators
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Principal Investigator: Siew Ng, PhD Chinese University of Hong Kong
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Responsible Party: Siew Chien NG, Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT02537210    
Other Study ID Numbers: ASA withdrawal study
First Posted: September 1, 2015    Key Record Dates
Last Update Posted: April 29, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Mesalamine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents