UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000010004
Receipt number R000011713
Scientific Title Safety and efficacy of Hange-shashin-to therapy for refractory pouchitis
Date of disclosure of the study information 2013/02/09
Last modified on 2014/03/21 20:25:46

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Basic information

Public title

Safety and efficacy of Hange-shashin-to therapy for refractory pouchitis

Acronym

Hange-shashin-to for refractory pouchitis

Scientific Title

Safety and efficacy of Hange-shashin-to therapy for refractory pouchitis

Scientific Title:Acronym

Hange-shashin-to 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 Hange-shashin-to 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

Hange-shashin-to 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

20 years-old <=

Age-upper limit

75 years-old >

Gender

Male and Female

Key inclusion criteria

Patients with chronic relapsing-remitting pouchitis after restorative proctocolectomy for ulcerative colitis.
PDAI scoreis more than7points.
Candidate has to agree to be enrolled for the study under sufficient written informed consent.

Key exclusion criteria

1)Concomitant administrations of antibiotics within 2weeks.
2)Concomitant administrations of Chinese medicine within 2weeks.
3) A patient, who is pregnant, may be pregnant, breast-feeds or hopes to be pregnant in the study period.
4) A patient who is determined as ineligible for a subject in this study by a doctor in charge or others.

Target sample size

15


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiroki Ikeuchi

Organization

Hyogo college of Medicine

Division name

Lower gastroenterological surgery /IBD center

Zip code


Address

Mukogawa-cho 1-1, Nishinomiya city, Hyogo, Japan

TEL

0798-45-6372

Email

ikeuci2s@hyo-med.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hiroki Matsuoka

Organization

Hyogo college of Medicine

Division name

gastroenterological surgery

Zip code


Address

1-1 mukogawa-cho, Nishinomiya city, Hyogo, Japan

TEL

0798-45-6372

Homepage URL


Email

m-hiro2s@hyo-med.ac.jp


Sponsor or person

Institute

Department of lower gastroenterological surgery, Hyogo college of Medicine

Institute

Department

Personal name



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)



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

2013 Year 02 Month 09 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

No longer recruiting

Date of protocol fixation

2013 Year 02 Month 09 Day

Date of IRB


Anticipated trial start date

2013 Year 02 Month 12 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

2013 Year 02 Month 08 Day

Last modified on

2014 Year 03 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011713


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name