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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000010544
Receipt No. R000012332
Scientific Title Investigation of the usefulness of drug change from one type to another type of 5-ASA (5-mesalamine) in the treatment of ulcerative colitis during the relapse state
Date of disclosure of the study information 2013/04/19
Last modified on 2013/04/19

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Basic information
Public title Investigation of the usefulness of drug change from one type to another type of 5-ASA (5-mesalamine) in the treatment of ulcerative colitis during the relapse state
Acronym Investigation of the usefulness of drug change from one type to another type of 5-ASA (5-mesalamine) in the treatment of ulcerative colitis during the relapse state
Scientific Title Investigation of the usefulness of drug change from one type to another type of 5-ASA (5-mesalamine) in the treatment of ulcerative colitis during the relapse state
Scientific Title:Acronym Investigation of the usefulness of drug change from one type to another type of 5-ASA (5-mesalamine) in the treatment of ulcerative colitis during the relapse state
Region
Japan

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

Objectives
Narrative objectives1 The present study will be done to know strong points of two different type of 5-ASA (5-mesalamine), Asacol and Pentasa, in the treatment of ulcerative colitis, by an analysis of the usefulness of the drugs stratified with type or severity of the disease when the type 5-ASA is changed from one type to another during the relapse state.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Reduction in CAI (Clinical Activity Index) four and eight weeks after the drug change
Key secondary outcomes Reduction in EI (Endoscopic Index) four and eight weeks after the drug change

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 For patients who relapsed during the maintenance with Pentasa are changed to Asacol 3600mg/day for eight weeks.

Patients, who relapsed during the maintenance with Asacol, are changed to Pentasa 4000mg/day for eight weeks.
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
16 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Ulceratice colitis patinets who relapsed during maintenance with Asacol or Pentasa

Patients, 16 years or older, who gave written consent on attending this study after enough explanation.
(For juveniles less than twenty years old, written consent of their parents is also needed.)
Key exclusion criteria Patients with severe diarrhea (>10 times a day) whom their primary doctors judged them as difficult to treat with oral drug.&nbsp;
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi Araki
Organization Gifu university hospital
Division name Division of endoscopy
Zip code
Address 1-1 Yanagido, Gifu City
TEL 058-230-6308
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hiroshi Araki
Organization Gifu university hospital
Division name Division of endoscopy
Zip code
Address
TEL
Homepage URL
Email araara@gifu-u.ac.jp

Sponsor
Institute GIFU UNIVERSITY GRADUATE SCHOOL OF MEDICINE
Institute
Department

Funding Source
Organization GIFU UNIVERSITY GRADUATE SCHOOL OF MEDICINE
Organization
Division
Category of Funding Organization Self funding
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 岐阜大学医学部附属病院

Other administrative information
Date of disclosure of the study information
2013 Year 04 Month 19 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
2013 Year 03 Month 07 Day
Date of IRB
Anticipated trial start date
2013 Year 04 Month 05 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
2013 Year 04 Month 19 Day
Last modified on
2013 Year 04 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012332

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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