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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031230024

Enrollment

Registered

2023-04-16

Start date

2023-04-22

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Ulcerative colitis in remission phase

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion 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

Design outcomes

Primary

Measure	Time frame
Nonoccurrence of rectal bleeding	—

Contacts

Public ContactPublic relations

Mochida Pharmaceutical Co., Ltd.

webmaster@mochida.co.jp+81-3-3225-6303

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026