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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	JPRN
Last refreshed on:	17 October 2023
Main ID:	JPRN-UMIN000030000
Date of registration:	01/12/2017
Prospective Registration:	Yes
Primary sponsor:	Department of Inflammatory Bowel Disease Hyogo College of Medicine
Public title:	The efficacy and safety of topical budezonide for pouchitis after restorative proctocolectomy in patients with ulcerative colitis.
Scientific title:	The efficacy and safety of topical budezonide for pouchitis after restorative proctocolectomy in patients with ulcerative colitis. - The efficacy and safety of topical budezonide for pouchitis.
Date of first enrolment:	2018/02/07
Target sample size:	30
Recruitment status:	Complete: follow-up complete
URL:	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034256
Study type:	Interventional
Study design:	Parallel Non-randomized
Phase:	Phase I

Countries of recruitment
Japan

Contacts

Name:	Motoi Uchino
Address:	1-1 Mukogawacho, Nishinomiya, Hyogo, Japan Japan
Telephone:	0798-45-6371
Email:	uchino2s@hyo-med.ac.jp
Affiliation:	Hyogo College of Medicine Department of Inflammatory Bowel disease

Name:	Motoi Uchino
Address:	1-1 Mukogawacho, Nishinomiya, Hyogo, Japan 663-8501 Japan
Telephone:	0798-45-6371
Email:	uchino2s@hyo-med.ac.jp
Affiliation:	Hyogo College of Medicine Department of Inflammatory Bowel Disease

Key inclusion & exclusion criteria

Inclusion criteria:
Exclusion criteria: Patients without agreement. Patients with drug allergy.

Age minimum: Not applicable
Age maximum: Not applicable
Gender: Male and Female

Health Condition(s) or Problem(s) studied

ulcerative colitis pouchitis

Intervention(s)

Topical budesonido 2weeks of 2mg daily
Topical prednisolone 2weeks 20mg daily
Topical aminosalicylate 2weeks 1g daily

Primary Outcome(s)

The remission rate after 2weeks of treatment.

Secondary Outcome(s)

The change of pouchitis disease activity index score during 2weeks of treatment. The rate of adverse events.

Secondary ID(s)

Source(s) of Monetary Support

Department of Inflammatory Bowel Disease Hyogo College of Medicine

Secondary Sponsor(s)

Ethics review

Status: YES
Approval date: 06/02/2018
Contact:

motoi.uchino@nifty.ne.jp

Hyogo College of Medicine

0798456371

motoi.uchino@nifty.ne.jp

Results

Results available:	Yes
Date Posted:
Date Completed:	31/03/2022
URL:

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