UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Safety and efficacy of topical tacrolimus therapy for refractory pouchitis
Title of the study (Brief title)	Tacrolimus for refractory pouchitis
Region	Japan

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

Objectives
Narrative objectives1	The topical applicability of tacrolimus for refractory pouchitis will be investigated.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Phase I

Assessment
Primary outcomes	Efficacy of treatment was defined Pouchitis Disease Activity Index score with each parameter which includes clinical symptoms, endoscopic appearance, and histopathological findings. These parameters were assessed at before and after treatment.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	topical tacrolimus administration
Interventions/Control_2
Interventions/Control_3
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	18 years-old <
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	Patients with chronic antibiotics refractory pouchitis after restorative proctocolectomy for ulcerative colitis
Key exclusion criteria	Concomitant administrations of other immunosuppressive therapies which includes corticosteroids,immunomodurators or biologics and 5-aminosalicylate or other local therapies which includes enemas or suppositories were not allowed.The patients with allergy for tacrolimus wereexcluded.
Target sample size	10

Research contact person
Name of lead principal investigator	Motoi Uchino
Organization	Hyogo college of Medicine
Division name	Lower gastroenterological surgery
Address	Mukogawa-cho 1-1, Nishinomiya city, Hyogo, Japan
TEL	0798-45-6371
Email	uchino2s@hyo-med.ac.jp

Public contact
Name of contact person	Motoi Uchino
Organization	Hyogo college of Medicine
Division name	Lower gastroenterological surgery
Address	Mukogawa-cho 1-1, Nishinomiya city, Hyogo, Japan
TEL	0798-45-6371
Homepage URL
Email	uchino2s@hyo-med.ac.jp

Sponsor
Institute	Department of lower gastroenterological surgery, Hyogo college of Medicine
Institute
Department

Funding Source
Organization	Department of lower gastroenterological surgery, 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)

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	兵庫医科大学(兵庫県）、Hyogo college of Medicine

Other administrative information
Date of disclosure of the study information	2011 Year 11 Month 03 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 07 Month 01 Day
Anticipated trial start date	2011 Year 09 Month 01 Day
Last follow-up date	2012 Year 09 Month 01 Day
Date of closure to data entry	2012 Year 10 Month 01 Day
Date trial data considered complete	2012 Year 12 Month 01 Day
Date analysis concluded	2012 Year 12 Month 01 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2011 Year 11 Month 02 Day
Last modified on	2017 Year 02 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000007490