UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026244
Receipt number R000030141
Scientific Title Single-center, open-label exploratory study to assess the efficacy and safety of TSUMURA Kamikihito Extract Granules for Ethical Use (TJ-137) for the treatment of anxiety in patients with chronic constipation syndrome
Date of disclosure of the study information 2017/02/21
Last modified on 2017/02/21 12:22:18

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Basic information

Public title

Single-center, open-label exploratory study to assess the efficacy and safety of TSUMURA Kamikihito Extract Granules for Ethical Use (TJ-137) for the treatment of anxiety in patients with chronic constipation syndrome

Acronym

Exploratory study to assess the efficacy and safety of TJ-137 for the treatment of anxiety in patients with chronic constipation syndrome

Scientific Title

Single-center, open-label exploratory study to assess the efficacy and safety of TSUMURA Kamikihito Extract Granules for Ethical Use (TJ-137) for the treatment of anxiety in patients with chronic constipation syndrome

Scientific Title:Acronym

Exploratory study to assess the efficacy and safety of TJ-137 for the treatment of anxiety in patients with chronic constipation syndrome

Region

Japan


Condition

Condition

Chronic constipation syndrome

Classification by specialty

Gastroenterology Psychosomatic Internal Medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Primary objective is to investigate the efficacy and safety of TSUMURA Kamikihito Extract Granules for Ethical Use (TJ-137) for the treatment of neuropsychiatric symptoms, in particular, anxiety as well as abdominal symptoms (such as abdominal pain, abdominal distention and discomfort) in patients with chronic constipation syndrome. Secondary objectives include the analysis of plasma and salivary oxytocin levels, and metabolomic and microbiome analysis of stool samples.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Comparison of the following results at baseline,
week 4, and week 12 of study drug
administration:
1) Tension-Anxiety subscale and anxiety-related
items on Profile of Mood States (POMS 2, Japanese version)
2) State-Trait Anxiety Inventory (Japanese version)

Key secondary outcomes

1) Other subscales on Profile of Mood States
(POMS2, Japanese version) not related to anxiety,
including Anger-Hostility, Confusion-Bewilderment, Depression-Dejection, Fatigue-Inertia, Vigor-Activity, Friendliness, and overall negative mood state (Total Mood Disturbance)
2) Gastrointestinal Symptom Rating Scale score
(v 1.2, Japanese version)
3) Plasma levels of oxytocin (OXT), serotonin
(5-HT), dopamine (DA), vasopressin (VSP), and
orexin (OR)
4) Oxidative stress markers including reactive oxygen metabolites (d-ROMS) and biological antioxidant potential (BAP)
5) Salivary levels of OXT, cortisol, IL-6, alpha-amylase, and chromogranin A
6) Changes in plasma metabolites
7) Changes in stool metabolites
8) Changes in gut microbiome


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

Oral administration of TJ-137
(2.5 g t.i.d) before meals for 90 days

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


Not applicable

Gender

Female

Key inclusion criteria

1. diagnosed with chronic constipation syndrome;
2. suffers from anxiety (POMS2 item 23 is 1 or
higher);
3. is 20 years old or older
4. is a female
5. can make outpatient visits
6. is able to provide written consent

Key exclusion criteria

Patients who meet any of the following criteria will be excluded from the study:
1. has taken prohibited concomitant medication within two weeks before the start of study;
2. has changed the dose and administration of restricted concomitant medication within two weeks before the start of study;
3. requires a new medication during the study other than the study drug;
4. has serious complications (liver, kidney, heart, and blood disorders or metabolic and psychiatric disorders);
5. is pregnant, breast-feeding or possibly pregnant women;
6. is otherwise deemed ineligible by the study investigator.

Target sample size

25


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiroyuki Kobayashi, M.D., Ph.D.

Organization

Kobayashi Medical Clinic Tokyo

Division name

Kobayashi Medical Clinic Tokyo

Zip code


Address

2-3-5 Akasaka, Minato-ku, Akasaka Star Gate Plaza 2F, Tokyo, 107-0052, Japan

TEL

0335893717

Email

koba@juntendo.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hiroyuki Kobayashi, M.D., Ph.D.

Organization

Juntendo University Graduate School of Medicine

Division name

Department of Hospital Administration, Center for Advanced Kampo Medicine and Clinical Research

Zip code


Address

2-1-1 Hongo, Bunkyo-ku, Tokyo, 113-8421, Japan

TEL

03(3813)3111

Homepage URL


Email

koba@juntendo.ac.jp


Sponsor or person

Institute

Kobayashi Medical Clinic Tokyo

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


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

小林メディカルクリニック東京 Kobayashi Medical Clinic Tokyo


Other administrative information

Date of disclosure of the study information

2017 Year 02 Month 21 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

Completed

Date of protocol fixation

2016 Year 08 Month 30 Day

Date of IRB


Anticipated trial start date

2016 Year 09 Month 05 Day

Last follow-up date

2017 Year 01 Month 12 Day

Date of closure to data entry

2017 Year 02 Month 22 Day

Date trial data considered complete

2017 Year 02 Month 28 Day

Date analysis concluded

2018 Year 12 Month 31 Day


Other

Other related information



Management information

Registered date

2017 Year 02 Month 21 Day

Last modified on

2017 Year 02 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030141


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name