Efficacy of high-dose oral multi matrix mesalamine (Mezavant®) and delayed-release mesalamine (Asacol®) for induction of remission in patients with mild to moderate ulcerative colitis: a prospective, multicenter, open-label, randomized comparative study

Efficacy of high-dose oral MMX mesalamine (Mezavant®) and delayed-release mesalamine (Asacol®) for induction of remission in patients with mild to moderate ulcerative colitis: a prospective, multicenter, open-label, randomized comparative study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0009194

Enrollment

300

Registered

2024-02-22

Start date

2024-02-05

Completion date

Unknown

Last updated

2024-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : MMX Group: Take Mezavant 1200 mg formulation, 4 tablets (totaling 4.8 g), once daily immediately after a meal at the same time every day for 8 weeks. Asacol Group: Take Asacol 1600 mg formulati

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Adults aged 19 and older with active mild to moderate ulcerative colitis: having a Mayo Score of 3-10, a Mayo Endoscopic Score of 1-2, and a Physician’s Global Assessment of =2, and either: 1) Newly diagnosed patients, or 2) Patients who have relapsed within 6 weeks of the screening point (during the screening period, taking a maintenance dose of 5-ASA of up to 2.4 g is allowed).

Exclusion criteria

Exclusion criteria: 1) Severe ulcerative colitis: Mayo Score =10 or Mayo Endoscopic Score 3 or Physician’s Global Assessment 3 2) Previous non-response or failure of treatment with steroids, azathioprine, or 5-ASA =2.4 g 3) In case of relapse, it occurred before 6 weeks from the screening point 4) Relapse on a maintenance dose of 5-ASA =2.4 g 5) Reduction in 5-ASA maintenance dose to <2.4 g within 2 weeks of the screening point 6) Steroid use within 4 weeks of the screening point 7) Azathioprine use within 6 weeks of the screening point 8) Antibiotics, PPIs, or NSAIDs use within 1 week of the screening point 9) Identification of infectious pathogens in stool tests 10) Moderate to severe systemic diseases 11) History of bowel surgery, peptic ulcer 12) Pregnancy

Design outcomes

Primary

Measure	Time frame
Clinical remission rates for each medication;Endoscopic (sigmoidoscopy) remission rates for each medication	—

Secondary

Measure	Time frame
Clinical response rates for each medication;Endoscopic (sigmoidoscopy) response rates for each medication;Changes in fecal calprotectin for each medication;Compliance with each medication;Adverse effects of each medication	—

Countries

Korea, Republic of

Contacts

Public ContactSoo-Young

The Catholic University of Korea, Incheon St. Mary's Hospital

sktndud@hanmail.net+82-32-280-7504

Outcome results