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Clinical Trials/jRCTs031210326
jRCTs031210326CompletedNot Applicable

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)

Not provided0 sites20 target enrollmentStarted: February 28, 2022Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
20
Primary Endpoint
Response rate of the study drug
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional
Allocation
Single Arm Study
Intervention Model
Single Assignment
Primary Purpose
Treatment Purpose
Masking
Open(masking Not Used)

Eligibility Criteria

Ages
16age old over to No limit (—)
Sex
All

Inclusion Criteria

  • •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)

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
  • •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.

Outcomes

Primary Outcomes

Response rate of the study drug

Time Frame: 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

Time Frame: 0 and 6 weeks

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

Secondary Outcomes

  • 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

Investigators

Sponsor
Not provided

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