The actual condition of combined use of topical preparations in oral 5-ASA preparation treatment for ulcerative colitis.

Not Applicable

• Conditions: lcerative Colitis

• Registration Number: JPRN-UMIN000044192
• Lead Sponsor: MOCHIDA PHARMACEUTICAL CO., LTD.

Brief Summary

The combination proportion of oral therapy with 5-ASA (OT5ASA) and topical therapy (TT) were 21.5 and 21.6% in cohorts 1 (OT5ASA only at the first prescribing) and 2 (TT only), respectively, with no differences between cohorts and medicines. For the proportion of subjects, which prescribing initiation was OT5ASA, with <25% of TT combinations, proportion of time-dependent, pH-dependent and MMX was 28.4, 28.1 and 42.9%, respectively, and OT5ASA continuation proportion were 46.9, 44.9 and 65.9%, respectively.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-12
• Study Completion: 2022-03-11
• Results First Posted: 2022-05-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 2247

Inclusion Criteria

Not provided

Exclusion Criteria

1. The following diagnostic or implementation records for 6 months from the previous month of the Index and for the next 13 months including the Index. -Crohn's disease -Colorectal cancer -Total and subtotal resection of the colorectal and colon 2. Oral 5-ASA prescriptions outside the approved dose range for the next 13 months, including Index date. 3. Records of unknown prescription dates for oral 5-ASA and topical preparations in the next 13 months, including the Index date. 4. Prescription with unknown drug name or standards for oral 5-ASA and topical preparations in the next 13 months, including the Index date.

Study & Design

• Study Type: Observational
• Study Design: Not specified