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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	JPRN
Last refreshed on:	17 October 2023
Main ID:	JPRN-UMIN000014205
Date of registration:	08/06/2014
Prospective Registration:	No
Primary sponsor:	Department of Gastroenterology Osaka City University Graduate School of Medicine
Public title:	Examination of the medical treatment by the pancrelipase to the refractory inflammatory bowel disease patient
Scientific title:	Examination of the medical treatment by the pancrelipase to the refractory inflammatory bowel disease patient - Validity of pancrelipase in patients with inflammatory bowel disease
Date of first enrolment:	2014/03/25
Target sample size:	30
Recruitment status:	Complete: follow-up complete
URL:	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016540
Study type:	Interventional
Study design:	Single arm Non-randomized
Phase:	Not selected

Countries of recruitment
Japan

Contacts

Name:	Noriko Kamata
Address:	1-4-3, Asahi-machi, Abeno-ku, Osaka, Japan 545-0051 Japan
Telephone:	06-6645-3811
Email:	nkamata@med.osaka-cu.ac.jp
Affiliation:	Osaka City University Graduate School of Medicine Department of Gastroenterology

Name:	Noriko Kamata
Address:	1-4-3, Asahi-machi, Abeno-ku, Osaka, Japan Japan
Telephone:	06-6645-3811
Email:	nkamata@med.osaka-cu.ac.jp
Affiliation:	Osaka City University Graduate School of Medicine Department of Gastroenterology

Key inclusion & exclusion criteria

Inclusion criteria:
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.

Age minimum: 20years-old
Age maximum: Not applicable
Gender: Male and Female

Health Condition(s) or Problem(s) studied

Crohn's disease Ulcerative colitis

Intervention(s)

Administration of pancrelipase

Primary Outcome(s)

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

Secondary Outcome(s)

Secondary ID(s)

Source(s) of Monetary Support

Osaka City University Graduate School of Medicine

Secondary Sponsor(s)

Ethics review

Status: YES
Approval date: 02/04/2014
Contact:

nkamata@med.osaka-cu.ac.jp

Osaka City University Graduate School of Medicine

0666453811

nkamata@med.osaka-cu.ac.jp

Results

Results available:	Yes
Date Posted:
Date Completed:	31/03/2018
URL:

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