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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000005970
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Kawasaki Medical School
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007049

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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