None listed
Conditions
Interventions
Drug : 1. MMX group: Mezavant 1200 mg (4 tablets, total 4.8 g) taken once daily at the same time each day, immediately after a meal, for 8 weeks.
2. Asacol group: Asacol 1600 mg (3 tablets, total 4.8
Sponsors
The Catholic University of Korea, Incheon St. Mary's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Adults aged 19 years or older with active mild to moderate ulcerative colitis, defined as a Mayo Score of 3-10, a Mayo Endoscopic Score of 1-2, and a Physician’s Global Assessment (PGA) of =2. - Newly diagnosed patients. - Relapse within 6 weeks prior to the screening visit: Patients may continue maintenance 5-ASA at a dose of up to 2.4 g during the screening period.
Exclusion criteria
Exclusion criteria: - Severe ulcerative colitis, defined as Mayo Score =10, Mayo Endoscopic Score of 3, or Physician’s Global Assessment (PGA) of 3. - Previous non-response or treatment failure with steroids, azathioprine, or 5-ASA at doses =2.4 g. - Relapse occurring more than 6 weeks prior to the screening visit. - Relapse while on maintenance 5-ASA at doses >2.4 g. - For patients on maintenance 5-ASA at doses =2.4 g, dose reduction within 2 weeks prior to screening. - Use of steroids within 4 weeks prior to screening. - Use of azathioprine within 6 weeks prior to screening. - Use of antibiotics, proton pump inhibitors (PPI), or nonsteroidal anti-inflammatory drugs (NSAIDs) within 1 week prior to screening. - Presence of infectious pathogens in stool examination. - Moderate to severe systemic diseases, such as cirrhosis, heart failure, renal failure, or immune disorders (e.g., lupus). - History of colorectal surgery or peptic ulcer disease. - Pregnancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical and endoscopic (sigmoidoscopic) remission rate at Week 8 (Mayo Score =2 and Endoscopic Mayo Score 0 or 1) | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical response rate at Week 8, Endoscopic (sigmoidoscopic) response rate at Week 8, Changes in fecal calprotectin at Week 8, Medication adherence at Week 8, Incidence of adverse events at Week 8 | — |
Countries
Korea, Republic of
Contacts
Public ContactHYUN JI SHIM
Yonsei University Health System, Severance Hospital
Outcome results
None listed