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 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
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
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
