UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005970 |
|---|---|
| Receipt number | R000007049 |
| Scientific Title | Investigation on the remission maintaining effect of Polaprezinc in patients with Crohn's disease in remission phase. |
| Date of disclosure of the study information | 2011/07/13 |
| Last modified on | 2011/07/13 14:57:01 |
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Basic information
Public title
Investigation on the remission maintaining effect of Polaprezinc in patients with Crohn's disease in remission phase.
Acronym
The Efficacy of Polaprezinc
Scientific Title
Investigation on the remission maintaining effect of Polaprezinc in patients with Crohn's disease in remission phase.
Scientific Title:Acronym
The Efficacy of Polaprezinc
Region
| Japan |
Condition
Condition
Patients with Crohn's disease in remission phase
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this trial is examine the remission maintaining effect of Polaprezinc in Crohn's disease in remission phase.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Crohn's disease activity index at 0,1,3,6,12 months after treatment and 1 month after end point.
Key secondary outcomes
Recurrence rate
Evaluation of subjective symptoms
QOL(F-8)
safty
change of labolatory data
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Polaprezinc administration group: patients has Polaprezinc 150mg/day for xxx months with Crohn's disease maintenance therapy.
Interventions/Control_2
Polaprezinc non administration group: patients treated with Crohn's disease maintenance therapy only.
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
Crohn's disease patients who have no change treatments for these three months in remission stage.
Able to provide informed consent.
Key exclusion criteria
1)Patients who had undergone total parental nutrition.
2)Patients with serious liverdysfunction and renaldysfunction
3)Patients with serious heart disease ,lung disease and hemo?
4)Patients with malignancy
5)Patients who has a allergic history against Polaprezinc
6)Patients who are pregnant or have the possibility of pregnancy
7)The patient who was judged for unsuitable by responsibility doctor.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ken Haruma |
Organization
Kawasaki Medical School
Division name
gastroenterology
Zip code
Address
577 Matsushima,Kurashiki,Okayama
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kawasaki Medical School
Division name
gastroenterology
Zip code
Address
577 Matsushima,Kurashiki,Okayama
TEL
Homepage URL
Sponsor or person
Institute
Kawasaki Medical School
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
川崎医科大学附属病院
チクバ外科胃腸科肛門科病院
佐藤胃腸科外科病院
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 07 | Month | 13 | 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
Open public recruiting
Date of protocol fixation
| 2011 | Year | 05 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 07 | Month | 13 | Day |
Last modified on
| 2011 | Year | 07 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007049
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
