Switch study between MD-0901 formulations in Patients with Ulcerative Colitis in Remission Phase

JRCT ID: jRCT2031230024

Registered date:16/04/2023

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Ulcerative colitis in remission phase
• Date of first enrollment: 22/04/2023
• Target sample size: 23
• Study type: Interventional

Intervention(s)

Period 1 : LIALDA 2,400 mg/day, orally
Period 2 : MD-0901 2,400 mg/day, orally

Outcome(s)

• Primary Outcome: Nonoccurrence of rectal bleeding

Key inclusion & exclusion criteria

• Age minimum: >= 16age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

- Patients diagnosed with ulcerative colitis
- Patients with a total score of =< 1 on the Partial Ulcerative Colitis Disease Activity Index (Partial UC-DAI) and with a rectal bleeding score of 0
- Patients using oral mesalazine or oral salazosulfapyridine at a dose of 2400 mg/day or less (mesalazine equivalent)
- Patients in remission for 12 weeks or longer

Exclude criteria

- Patients with a history of colectomy except for appendectomy
- Patients with moderate/severe renal or liver impairment
- Patients with serious blood disorder, respiratory disorder, digestive disorder, cardiovascular disorder, psychiatric disorder, abnormal electrolyte metabolism disorder or hypersensitivity
- Patients with malignant tumor

Related Information

• Primary Sponsor: Kusaba Keiko