UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031475
Receipt number R000035929
Scientific Title The efficacy of Daikenchuto (TJ-100) on abdominal discomfort (pain) in patients with defecation disorders: a retrospective study
Date of disclosure of the study information 2018/03/01
Last modified on 2020/09/08 10:30:07

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Basic information

Public title

The efficacy of Daikenchuto (TJ-100) on abdominal discomfort (pain) in patients with defecation disorders: a retrospective study

Acronym

The efficacy of Daikenchuto (TJ-100) on abdominal discomfort (pain) in patients with defecation disorders: a retrospective study

Scientific Title

The efficacy of Daikenchuto (TJ-100) on abdominal discomfort (pain) in patients with defecation disorders: a retrospective study

Scientific Title:Acronym

The efficacy of Daikenchuto (TJ-100) on abdominal discomfort (pain) in patients with defecation disorders: a retrospective study

Region

Japan


Condition

Condition

defecation disorders

Classification by specialty

Hepato-biliary-pancreatic surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To elucidate the improvement effect of daikenchuto on the abdominal discomfort (pain) in patients with defecation disorders by using Constipation Scoring System (CSS) etc.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Change in score of CSS (Constipation Scoring System) before and after administration of daikenchuto

Key secondary outcomes

1. Change in score of CCIS (Cleveland Clinic Incontinence Score) before and after administration of daikenchuto
2. Change in anal pressure before and after administration of daikenchuto
3. To explore the influencing factors on change in CSS, CCIS and anal pressure before and after administration of daikenchuto


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1. Patients who proceeded to be dosed daikenchuto between January 1, 2012 and December 31, 2016
2. Patient with defecation disorder

Key exclusion criteria

Patient without abdominal discomfort (pain) before proceeding to be dosed

Target sample size

200


Research contact person

Name of lead principal investigator

1st name Tatsuya
Middle name
Last name Abe

Organization

Kunimoto Hospital

Division name

Department of Proctology

Zip code

070-0061

Address

1-7-2-1 Akebono, Asahikawa, Hokkaido

TEL

0166-25-2241

Email

t-abe@cf6.so-net.ne.jp


Public contact

Name of contact person

1st name Tatsuya
Middle name
Last name Abe

Organization

Kunimoto Hospital

Division name

Department of Proctology

Zip code

070-0061

Address

1-7-2-1 Akebono, Asahikawa, Hokkaido

TEL

0166-25-2241

Homepage URL


Email

t-abe@cf6.so-net.ne.jp


Sponsor or person

Institute

Kunimoto Hospital

Institute

Department

Personal name



Funding Source

Organization

Tsumura & Co.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

Tsumura & Co.

Name of secondary funder(s)



IRB Contact (For public release)

Organization

IRB of the Maebashi Hirosegawa Clinic

Address

2-10-9 Chiyotamachi Maebashi-shi Gunma

Tel

027-231-4101

Email

kaneko@smo-msr.co.jp


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

医療法人健康会くにもと病院(北海道)


Other administrative information

Date of disclosure of the study information

2018 Year 03 Month 01 Day


Related information

URL releasing protocol

https://upload.umin.ac.jp/cgi-bin/ctr/ctr_file_dl.cgi?recptno=R000035929&file_id=00001&file_kind=1

Publication of results

Published


Result

URL related to results and publications

https://doi.org/10.23922/jarc.2019-012

Number of participants that the trial has enrolled

157

Results

On the CCIS, total score was significantly improved after administration of DKT. On the CSS, no significant difference was found in the total score. On the Bristol Stool Form Scale, DKT showed a tendency to normalize stool consistency. Maximum resting anal pressure and maximum squeeze anal pressure significantly increased after the administration of DKT. No side effects caused by DKT were observed during the study.

Results date posted

2020 Year 09 Month 08 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

A total of 157 patients who fulfilled the appropriate criteria within the study period were enrolled. Their mean age was 73.6 years old, and female patients accounted for 75%.
The type of FI was passive incontinence in 86 cases, urge incontinence in 8 cases, and passive and urge incontinence in 63 cases.
Of the subjects of this study, 45 had already used laxatives.

Participant flow

Patients who visited the hospital from January 2012 to December 2016 due to FI as the major complaint and were treated with DKT were included as study participants. Patients with organic disorders of the rectoanal region, such as rectal prolapse, abscess, and tumor, or who used treatment other than DKT were excluded.
As this is a retrospective observational research using existing data collected by the hospital, the written consent was not obtained from the patients in advance. Therefore, the contents of the research were posted in the hospital to inform the subjects, providing the opportunity to refuse the usage of their data in the research.

Adverse events

No side effects caused by DKT were observed during the study period.

Outcome measures

Clevaland Clinic Incontinence Score
Constipation Scoring System
Bristol Stool Form Scale
Maximum resting anal pressure
Maximum squeeze anal pressure

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Main results already published

Date of protocol fixation

2018 Year 01 Month 09 Day

Date of IRB

2018 Year 01 Month 24 Day

Anticipated trial start date

2018 Year 03 Month 01 Day

Last follow-up date

2018 Year 11 Month 28 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Retrospective study of patients who proceeded to be dosed daikenchuto between January 1, 2012 and December 31, 2016


Management information

Registered date

2018 Year 02 Month 26 Day

Last modified on

2020 Year 09 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035929


Research Plan
Registered date File name
2020/09/08 UMIN000031475_protocol.pdf

Research case data specifications
Registered date File name

Research case data
Registered date File name