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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000030000
Receipt No. R000034256
Scientific Title The efficacy and safety of topical budezonide for pouchitis after restorative proctocolectomy in patients with ulcerative colitis.
Date of disclosure of the study information 2017/12/01
Last modified on 2017/11/16

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Basic information
Public title The efficacy and safety of topical budezonide for pouchitis after restorative proctocolectomy in patients with ulcerative colitis.
Acronym The efficacy and safety of topical budezonide for pouchitis.
Scientific Title The efficacy and safety of topical budezonide for pouchitis after restorative proctocolectomy in patients with ulcerative colitis.
Scientific Title:Acronym The efficacy and safety of topical budezonide for pouchitis.
Region
Japan

Condition
Condition ulcerative colitis
pouchitis
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to evaluate the efficacy and safety of topical budesonide for pouchitis in patients with ulcerative colitis.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase I

Assessment
Primary outcomes The remission rate after 2weeks of treatment.
Key secondary outcomes The change of pouchitis disease activity index score during 2weeks of treatment.
The rate of adverse events.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Topical budesonido
2weeks of 2mg daily
Interventions/Control_2 Topical prednisolone
2weeks 20mg daily
Interventions/Control_3 Topical aminosalicylate
2weeks 1g daily
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with agreement.
Patients with pouchitis.
Key exclusion criteria Patients without agreement.
Patients with drug allergy.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Motoi Uchino
Organization Hyogo College of Medicine
Division name Department of Inflammatory Bowel disease
Zip code
Address 1-1 Mukogawacho, Nishinomiya, Hyogo, Japan
TEL 0798-45-6371
Email uchino2s@hyo-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Motoi Uchino
Organization Hyogo College of Medicine
Division name Department of Inflammatory Bowel Disease
Zip code
Address 1-1 Mukogawacho, Nishinomiya, Hyogo, Japan
TEL 0798-45-6371
Homepage URL
Email uchino2s@hyo-med.ac.jp

Sponsor
Institute Department of Inflammatory Bowel Disease
Hyogo College of Medicine
Institute
Department

Funding Source
Organization Department of Inflammatory Bowel Disease
Hyogo College of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2017 Year 12 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 11 Month 16 Day
Last modified on
2017 Year 11 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034256

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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