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The purpose of this study is to determine whether aminosalicylic acid (ASA) can be safely withdrawn in patients with long-standing clinical inactive UC.
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years and Over|
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
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Chinese University of Hong Kong|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Siew Ng, PhD|
|Principal Investigator Affiliation||Chinese University of Hong Kong|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
|Colitis, Ulcerative, Aminosalicylic Acid|
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.
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.