Prospective, Post Marketing Surveillance of RECTABUL2mg rectal form

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-jRCT1080223802

Enrollment

600

Registered

2018-02-08

Start date

2018-02-08

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 (except for severe disease)

Interventions

investigational material(s) Generic name etc : RECTABUL2mg rectal form INN of investigational material : Budesonide Therapeutic category code : 239 Other agents affecting digestive organs Dosage and A

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Ulcerative colitis patients

Exclusion criteria

Exclusion criteria: Off-label use

Design outcomes

Primary

Measure	Time frame
safety Partial Mayo Score Evaluate the difference in measurement before and after administration	—

Secondary

Measure	Time frame
efficacy Mayo sub-score, VAS, Laboratory test value Evaluate the difference in measurement before and after administration	—

Countries

Japan

Outcome results

None listed

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