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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000025499
Receipt No. R000029344
Scientific Title Quetionnaire survey on the drug compliance of ulcerative colitis patients(observational study)
Date of disclosure of the study information 2017/01/03
Last modified on 2018/05/21

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Basic information
Public title Quetionnaire survey on the drug compliance of ulcerative colitis patients(observational study)
Acronym Quetionnaire survey on the drug compliance of ulcerative colitis patients
Scientific Title Quetionnaire survey on the drug compliance of ulcerative colitis patients(observational study)
Scientific Title:Acronym Quetionnaire survey on the drug compliance of ulcerative colitis patients
Region
Japan

Condition
Condition Ulcerative colitis
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To establish an drug administration method that further increase the adherence to the medical therapy, to clarify the effect of the medical treatment on the influence of compliance, to ascertain the level of noncompliance of current prescribed medication through the administration of a questionnaire.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes To determine the drug compliance rate according to taking method.
Key secondary outcomes To determine the relation between disease activity and drug administration noncompliance.
To determine the relation between thiopurine metabolites and 6-thioguanine nucleotides levels.

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who are receiving 5-aminosalicylic acid or thiopurine metabolites used treatment at our hospital's outpatient clinic for ulcerative colitis.
Key exclusion criteria Patients who are unable to consent to the study.
Target sample size 350

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Fumihito Hirai
Organization Fukuoka University Chikushi Hospital
Division name Inflammatory Bowel Disease Center
Zip code
Address 1-1-1,Zokumyoin,Chikushino,Fukuoka
TEL 092-921-1011
Email fuhirai@cis.fukuoka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tsuyoshi Beppu
Organization Fukuoka University Chikushi Hospital
Division name Gastroenterology
Zip code
Address 1-1-1,Zokumyoin,Chikushino,Fukuoka
TEL 092-921-1011
Homepage URL
Email beppu1979@fukuoka-u.ac.jp

Sponsor
Institute Fukuoka University Chikushi Hospital
Institute
Department

Funding Source
Organization Fukuoka University Chikushi Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor None
Name of secondary funder(s) None

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 福岡大学筑紫病院(福岡県)

Other administrative information
Date of disclosure of the study information
2017 Year 01 Month 03 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 Enrolling by invitation
Date of protocol fixation
2016 Year 12 Month 19 Day
Date of IRB
Anticipated trial start date
2017 Year 01 Month 04 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We will investigate the following items in a questionnaire survey.
1. Patient background
types of 5-aminosalicylic acid or thiopurin metabolites,dose method,employment status,dietary intakes,drug administration noncompliance,medical condition
2.Blood test

Management information
Registered date
2017 Year 01 Month 03 Day
Last modified on
2018 Year 05 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029344

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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