UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010544 |
|---|---|
| Receipt number | 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 16:56:19 |
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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.
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
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
araara@gifu-u.ac.jp
Sponsor or person
Institute
GIFU UNIVERSITY GRADUATE SCHOOL OF MEDICINE
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012332
