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
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
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
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
