Ulcerative colitis
Conditions
Interventions
None listed
Sponsors
EA Pharma Co., Ltd. KISSEI PHARMACEUTICAL CO., LTD.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with active ulcerative colitis. 2) "How often during the last 2 weeks have you been troubled because of fear of not finding a washroom?" Patient who answered Frequency" or "almost every time" or "Total" to question. 3) Patients whose oral 5-ASA dose has not been changed for 2 weeks prior to the start of the observation period. 4) Patients who are judged by physicians to be appropriate to administer budesonide foam twice a day due to ineffective or difficult another enema administration. 5) Patients who can record a diary according to the investigator instructions. 6) Patients who can continue to visit the hospital during the study.
Exclusion criteria
Exclusion criteria: 1) Patients who have received budesonide foam. 2) Patients receiving 5-ASA (suppository, enema) at the beginning of the observation period. 3) Patients who used steroid enema and steroid suppositories within 2 weeks before the start of observation. 4) Patient who changed the dose of immunomodulator within 8 weeks before the start of observation. 5) Patients receiving treatment with the following drugs a. Oral steroid b. JAK inhibitor c. Calcineurin inhibitor 6) Patients treated with apheresis. 7) Patients who have been or have been treated with biologics. 8) Patients with a history of colorectal resection of the rectum and sigmoid colon or patients who are scheduled for surgical treatment of the gastrointestinal tract during the study period. 9) Patients deemed inappropriate by the investigator to conduct this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of Loss of bowel urgency | — |
Countries
Japan
Contacts
Public ContactKatsutoshi Inagaki
EA Pharma Co., Ltd. Department of Medical
Outcome results
None listed