UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025499
Receipt number 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 11:41:47

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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 or person

Institute

Fukuoka University Chikushi Hospital

Institute

Department

Personal name



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

Value
https://center6.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