Clinical efficacy of budesonide foam in patients with ulcerative colitis taking the maximum dose of oral mesalazine -retrospective observational study-

Clinical efficacy of budesonide foam in patients with ulcerative colitis taking the maximum dose of oral mesalazine -retrospective observational study- - Clinical efficacy of budesonide foam in patients with ulcerative colitis taking the maximum dose of oral mesalazine -retrospective observational study-

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000036077

Enrollment

Registered

2019-03-05

Start date

2019-03-01

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)Males and females aged at least 16 years at pre-treatment. 2)Patients diagnosed with mild to moderate ulcerative colitis. 3)Patients with rectosigmoid inflammation detected by colonoscopy or anoscopy within one month before treatment. 4)Patients treated with twice daily budesonide foam during the study period. 5)Patients prescribed with the maximum dose of daily mesalazine formulation from at least 4 weeks before the beginning of budesonide foam treatment to the end of the treatment. (Asacol tablets 3.6g, Pentasa tablets 4.0g, Pentasa granules 4.0g, Salazosulfapyridine tablets 4.0g, Lialda tablets 4.8g) 6)Patients who underwent colonoscopy for response evaluation within 2 months after the end of budesonide foam treatment.

Exclusion criteria

Exclusion criteria: Patients who changed dosage and administration of formulations including steroids and thiopurines during the treatment period.

Design outcomes

Primary

Measure	Time frame
Difference in Mayo endoscopic subscore (MES) between pre-treatment and post-treatment evaluation (patients treated with budesonide foam for at least 6 weeks)	—

Secondary

Measure	Time frame
Difference in Mayo score between pre-treatment and post-treatment evaluation (patients treated with budesonide foam for at least 6 weeks)	—

Countries

Japan

Contacts

Public ContactToshihide Ohmori

Ohmori Toshihide gastro-Intestinal Clinic Director

info@ohmori-toshihide-clinic.com048-778-4567

Outcome results