JPRN-jRCTs031210326
Active, not recruiting
未知
A multicenter study to evaluate the effectiveness of budesonide enema foam treatment and the usefulness ofserum biomarker measurement for active ulcerative colitis - BF-LRG
Matsuoka Katsuyoshi0 sites20 target enrollmentSeptember 21, 2021
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- lcerative colitis
- Sponsor
- Matsuoka Katsuyoshi
- Enrollment
- 20
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Include patients with mild to moderate UC who meet all the following 1 to 6\.
- •1\. Patients diagnosed with UC according to the ulcerative colitis/Crohn's disease diagnostic criteria and treatment guidelines (revised in 2019\)
- •2\. Patients whose total Mayo score evaluated on the eligibility confirmation date was 10 points or less and each sub\-score met the following.
- •(1\) Patients with MES \>\_ 2 at the most active site from the rectum to the sigmoid colon and \<\_ 1 at the proximal site beyond the sigmoid colon on colonoscopy performed on the eligibility confirmation date.
- •(2\) Patients with a physician's general assessment score of 1\-2 on the eligibility confirmation date.
- •3\. Gender: Not specified.
- •4\. Age: 16 years or older (at the time of acquisition of Consent)
- •5\. Visit classification: Outpatient
- •6\. Patients who can obtain written consent (however, if the patient is under 20 years old, obtain written consent from the substitute)
Exclusion Criteria
- •1\.Patients who received the following pharmacotherapy or treatment within the period of time as shown below:
- •\[Two weeks before the start date of study drug administration]
- •New addition of mesalazine preparation (enema / suppository) and salazosulfapyridine preparation (suppository)
- •Antidiarrheal drug
- •Bowel cleaning composition (Except used for pre\-preparation of colonoscopy in this clinical study)
- •Laxatives (Except used for pre\-preparation of colonoscopy in this clinical study)
- •Enema (Except used for pre\-preparation of colonoscopy in this clinical study)
- •\[Four weeks before the start date of study drug administration]
- •If the dose of Mesalazine formulations is over then 4\.0 g/day (excluding Asacol tablets and Rialda tablets)
- •If the dose of Asacol tablets is over then 3\.6 g/day
Outcomes
Primary Outcomes
Not specified
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