UMIN-CTR Clinical Trial

Public title

Exploratory study evaluating efficacy, safety and mechanism of Daikenchuto on abdominal pain or bloating accompanied by Crohn disease.

Acronym

CD DKT trial

Scientific Title

Exploratory study evaluating efficacy, safety and mechanism of Daikenchuto on abdominal pain or bloating accompanied by Crohn disease.

Scientific Title:Acronym

CD DKT trial

Region

Japan

Condition

Subjects with quiescent Crohn disease having abdominal pain or bloating

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluate efficacy, safety and mechanism of Daikenchuto on abdominal pain or bloating accompanied by Crohn disease.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Primary outcomes

1 Abdominal pain (The questionnaire item in CDAI: Abdominal pain in the past week)
2 Abdominal bloating (Question 17 and 20 in Japanese version of IBDQ)

Key secondary outcomes

1 CDAI
2 Japanese version of IBDQ
3 Serum concentrations and blood mRNA levels of following substances
Adrenomedullin, CGRP,
Receptors for adrenomedullin or CGRP and Cytokines
4 Protein and mRNA levels of following substances in peripheral mononuclear cells
Adrenomedullin, CGRP, Cytokines and their receptors
5 Discontinuance rate of study

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Blocking

YES

Concealment

Numbered container method

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Administered group:
Oral administration of Daikenchuto 15g/day for 24 weeks in addition to ordinary treatment for Crohn disease

Interventions/Control_2

Non-administered group:
Ordinary treatment for Crohn disease

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

16

years-old

<=

Age-upper limit

70

years-old

>=

Gender

Male and Female

Key inclusion criteria

Selection criteria at the time of obtaining patient agreement
1 Patients diagnosed with Crohn disease
2 Patients with abdominal pain or bloating
3 Age: 16 to 70 years old at the time of giving informed consent
4 Gender: Not specified
5 Inpatient/outpatient: Not specified
6 Patients who can give written informed consent (When patients are under the age of 20, written informed consent must be obtained by their legal guardians as well as by themselves)
Selection criteria at the time of enrollment
1 Patients who had changed dosage and administration of other medication for Crhon disease just before 4 weeks of obtained the informed consent
2 Patients who had kept their patient diaries for seven days before enrollment
3 Patients with CDAI less than 150

Key exclusion criteria

1 Patients with short bowel syndrome
2 Patients who require surgical treatment
3 Patients with malignancy
4 Patients who can take medicines orally
5 Patients under treatment for psychiatric disorder (including depression)
6 Patients with stoma
7 Patients who took Kampo medicines within 4weeks before enrollment
8 Patients taking drugs under development
9 Patients with serious complications (liver, kidney, heart, circulatory, or metabolic disorder)
10 Patients who are lactating, pregnant or considering conception
11 Others, including patients who are unfit for the study as determined by the investigator

Target sample size

30

Name of lead principal investigator

1st name
Middle name
Last name	Keiichi Mitsuyama

Organization

Kurume university

Division name

Inflammatory bowel disease center, Division of gastroenterology, Department of medicine

Zip code

Address

67 Asahi-machi, Kurume City, Fukuoka Prefecture

TEL

81-942-31-7561

Email

nina@med.kurume-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Hiroshi Yamasaki

Organization

Kurume university

Division name

Division of gastroenterology, Department of medicine

Zip code

Address

67 Asahi-machi, Kurume City, Fukuoka Prefecture

TEL

81-942-31-7561

Homepage URL

Email

nina@med.kurume-u.ac.jp

Institute

Kurume university

Institute

Department

Personal name

Organization

Tsumura & Co.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2013

Year

12

Month

24

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Open public recruiting

Date of protocol fixation

2013

Year

09

Month

27

Day

Date of IRB

Anticipated trial start date

2013

Year

12

Month

25

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2013

Year

12

Month

20

Day

Last modified on

2013

Year

12

Month

20

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014778