UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014205
Receipt number R000016540
Scientific Title Examination of the medical treatment by the pancrelipase to the refractory inflammatory bowel disease patient
Date of disclosure of the study information 2014/06/08
Last modified on 2019/06/12 10:41:44

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Basic information

Public title

Examination of the medical treatment by the pancrelipase to the refractory inflammatory bowel disease patient

Acronym

Validity of pancrelipase in patients with inflammatory bowel disease

Scientific Title

Examination of the medical treatment by the pancrelipase to the refractory inflammatory bowel disease patient

Scientific Title:Acronym

Validity of pancrelipase in patients with inflammatory bowel disease

Region

Japan


Condition

Condition

Crohn's disease
Ulcerative colitis

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate efficacy of pancrelipase in intractable inflammatory bowel disease

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Does the increase group in BMI 5% after 24 weeks of medication exceed a threshold value effectiveness rate from before medication or not?

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

Administration of pancrelipase

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

Male and Female

Key inclusion criteria

1)The patient who has agreed with participation of this research with the consent explanatory note document
2)An adult IBD patient aged 20 and over
3)The patient who continued the existing medical treatment including an anti-TNF-alpha antibody two months or more
4)A patient with the water or a muddy stool, or a less than 20-BMI patient
5)A patient with a low disease activity endoscopically.

Key exclusion criteria

1) The patient who has merged chronic pancreatitis
2) A patient with the past of the stomach and pancreatectomy
3) The patient who has allergy in pig protein
4) A patient under a pregnant woman and breast-feeding and with a possibility of having become pregnant
5) The patient who has participated in other clinical trials
6) The patient who has suffered from critical infection.
7) The patient who was not able to get consent to the participation in this clinical study.
In addition, the patient whom the examination responsibility (assignment) doctor judged to be unsuitable as a subject.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Noriko
Middle name
Last name Kamata

Organization

Osaka City University Graduate School of Medicine

Division name

Department of Gastroenterology

Zip code

545-8585

Address

1-4-3, Asahi-machi, Abeno-ku, Osaka, Japan

TEL

06-6645-3811

Email

nkamata@med.osaka-cu.ac.jp


Public contact

Name of contact person

1st name Noriko
Middle name
Last name Kamata

Organization

Osaka City University Graduate School of Medicine

Division name

Department of Gastroenterology

Zip code

545-0051

Address

1-4-3, Asahi-machi, Abeno-ku, Osaka, Japan

TEL

06-6645-3811

Homepage URL


Email

nkamata@med.osaka-cu.ac.jp


Sponsor or person

Institute

Department of Gastroenterology
Osaka City University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Osaka City University Graduate School 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

Osaka City University Graduate School of Medicine

Address

1-4-3, Asahi-machi, Abeno-ku, Osaka, Japan

Tel

0666453811

Email

nkamata@med.osaka-cu.ac.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



Other administrative information

Date of disclosure of the study information

2014 Year 06 Month 08 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

2014 Year 02 Month 28 Day

Date of IRB

2014 Year 04 Month 02 Day

Anticipated trial start date

2014 Year 03 Month 25 Day

Last follow-up date

2018 Year 03 Month 31 Day

Date of closure to data entry

2018 Year 03 Month 31 Day

Date trial data considered complete

2018 Year 03 Month 31 Day

Date analysis concluded

2019 Year 12 Month 31 Day


Other

Other related information



Management information

Registered date

2014 Year 06 Month 08 Day

Last modified on

2019 Year 06 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016540


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name