A multicenter study to evaluate the effectiveness of budesonide enema foam treatment and the usefulness of serum biomarker measurement for active ulcerative colitis (BF-LRG)

未提供0 个研究点目标入组 20 人开始时间: 2022年2月28日最近更新: 2024年9月30日

适应症

试验速览

阶段: 不适用
状态: 已完成
入组人数: 20
主要终点: Response rate of the study drug

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional
分配方式: Single Arm Study
干预模型: Single Assignment
主要目的: Treatment Purpose
盲法: Open(masking Not Used)

入排标准

年龄范围: 16age old over 至 No limit（—）
性别: All

入选标准

•Include patients with mild to moderate UC who meet all the following 1 to
•Patients diagnosed with UC according to the ulcerative colitis/Crohn's disease diagnostic criteria and treatment guidelines (revised in 2019)
•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.
•Gender: Not specified.
•Age: 16 years or older (at the time of acquisition of Consent)
•Visit classification: Outpatient
•Patients who can obtain written consent (however, if the patient is under 20 years old, obtain written consent from the substitute)

排除标准

•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
•If the dose of Rialda tablets is over then 4.8 g/day.
•If the dose of Salazosulfapyridine formulation is over then 8.0 g/day
•Leukocytapheresis
•Antibiotics or antibacterial drugs for the treatment of UC.
•Live vaccines
•[Eight weeks before the start date of study drug administration]
•Corticosteroid formulations (oral, enema, suppositories, hemorrhoid treatment, inhalants, injections)
•[Twelve weeks before the start date of study drug administration]
•Immunomodulators(cyclosporine, tacrolimus, methotrexate, azathioprine,6-mercaptopurine)
•Antibody preparation (anti-TNFa antibody agents, vedolizumab, ustekinumab)
•JFK inhibitors (tofacitinib)
•Patients who have changed the dosage or administration of the following drug therapies within the following period:
•[One weeks before the start date of study drug administration]
•[Two weeks before the start date of study drug administration]
•Mesalazine preparation (enema / suppository), salazosulfapyridine preparation (suppository)
•[Four weeks before the start date of study drug administration]
•Mesalazine formulations (oral), salazosulfapyridine formulation preparation (oral)
•Patients with a history of resection of the sigmoid colon or rectum (excluding polypectomy), or patients scheduled for surgical treatment of the gastrointestinal tract during the study period.
•Patients who are suspected clinically to have infectious enteritis.
•Patients with infectious diseases and deep mycoses for which there is no effective antibacterial agent.
•Patients with serious heart disease, nephropathy, or hepatic disorder
•Patients with (or suspected to diagnosed with) malignant tumor
•Female patients who are pregnant, lactating, or who may be pregnant
•Patients who wish to become pregnant during the administration period of this study drug, or female patients who do not agree with using any appropriate medical methods for contraception (concomitant use of intrauterine devices, pessaries, or partner condoms, etc. However, the use of oral contraceptives is excluded).
•Patients with a history of allergic reaction to budesonide
•Patients who are receiving desmopressin acetate hydrate
•Patients who participated in other clinical trials within 12 weeks prior to any examination or observation specified in this study protocol
•Other patients who are judged to be inappropriate for this study by the principal investigator, etc.

结局指标

主要结局

Response rate of the study drug

时间窗: week 6

Ratio of patients with response*1 among the enrolled patients *1 Response is defined by MES of 0 or 1, the rectal bleeding sub-score of 0, and stool frequency sub-score of 1 or less at week 6. *2: MES is evaluated by the Endoscopic Score Evaluation Committee.

Before-and-after comparison of LRG values

时间窗: 0 and 6 weeks

Comparison of LRG values at 0 and 6 weeks in patients with response (paired median test will be performed)

次要结局

Percentage changes in biomarkers(Week 6)
Cut off value by ROC analysis
Correlation with inflammation type
Correlation with Mayo score sub-scores
Correlation with cytokine expression level
Histological evaluation of colonic mucosa

研究者

发起方

未提供

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