UMIN-CTR Clinical Trial

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
Institute	Department of Gastroenterology Osaka City University Graduate School of Medicine
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000016540