None listed
Conditions
Interventions
None listed
Sponsors
Kangbuk Samsung Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ?Age Eligible: At least 18 Years ? Ulcerative colitis patients diagnosed with abnormality including ulceration and friability in more than sigmoid colon, who has been maintaining the remission by taking 5-ASA treatment for more than 3 month. (Patients who can maintain Partial Mayo score of 2 or below for at least 3 months) ? Patients that have been using the stable dose of steroid, immunosuppressant, and/or suppository product for more than 3 months ? Patients who have received and signed the informed consent
Exclusion criteria
Exclusion criteria: ?Patients with a history of using Biologic agent ? Patients who have been using the stable dose of Steroid, immunosuppressant, and/or suppository product for less than 3 months ? Patients with a history of colectomy ? Patients that are breast feeding, pregnant, or with a chance of being pregnant ? Patients with unstable psychiatric disease or who is unable to adopt to the trial ? Patients that are allergic to 5-ASA ? Patients who showed no remission to 5-ASA treatment for 3 months ? Patients with severe or fulminant Ulcerative Colitis ? Patients that use higher than 2.4g/d of Oral mesalazine containing product in less than 3 months ? Patients with heart failure, heart disease, and other severe diseases. ? Patients with other inflammatory disease and/or infectious colitis ? Patients with problem in liver & kidney function by laboratory test
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The adherence of 5-ASA comparing 2.4g once daily with 800mg three times or 1200mg twice daily for maintain therapy in the ulcerative colitis | — |
Secondary
| Measure | Time frame |
|---|---|
| The relapse rate includes time until confirmed relapse rate, time to relapse, residual symptoms and analysis of adverse events | — |
Countries
Korea, Republic of
Contacts
Public ContactDong il Park
Kangbuk Samsung Medical Center
Outcome results
None listed