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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000044192

Enrollment

2200

Registered

2021-05-12

Start date

2021-04-01

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

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Datebase registration within the database period. 2. Prescription of oral 5-ASA preparation or topical preparation of 5-ASA or steroid (topical preparation) with diagnosis of ulcerative colitis within the database period. 3. Prescriptions of oral 5-ASA or topical preparations with the earliest diagnosis of ulcerative colitis (Index date) are within the enrollment period. 4. Possible to observe for 6 months from the month before the index date. 5. Possible to observe for the next 13 months including the index date. 6. No treatment for ulcerative colitis for 6 months from the month before the index date. 7. No treatment for ulcerative colitis other than oral 5-ASA or topical preparations in the next 13 months, including Index date. 8. The age at the time of Index date is 16 years or older.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
1.Combination rate 2.Period until the start of combined use 3.Combination duration 4.Combination continuation rate 5.Combination rate transition 6.Oral 5-ASA continuation proportion	—

Countries

Japan

Contacts

Public ContactTakahiro Nitta

MOCHIDA PHARMACEUTICAL CO., LTD. MEDICAL AFFAIRS

takahiro.nitta@mochida.co.jp03-3225-5138

Outcome results