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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014205
Receipt No. 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

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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
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/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


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