UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009937 |
|---|---|
| Receipt number | R000011642 |
| Scientific Title | The efficacy of Mesarazine drugs treatment for clinical relapse in ulcerative colitis patients, compared 3600mg of Asacolo(r) with 4000mg Pentasa(r) |
| Date of disclosure of the study information | 2013/02/05 |
| Last modified on | 2013/02/07 18:19:37 |
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Basic information
Public title
The efficacy of Mesarazine drugs treatment for clinical relapse in ulcerative colitis patients, compared 3600mg of Asacolo(r) with 4000mg Pentasa(r)
Acronym
The efficacy of Mesarazine drugs treatment for clinical relapse in ulcerative colitis patients, compared 3600mg of Asacolo(r) with 4000mg Pentasa(r)
Scientific Title
The efficacy of Mesarazine drugs treatment for clinical relapse in ulcerative colitis patients, compared 3600mg of Asacolo(r) with 4000mg Pentasa(r)
Scientific Title:Acronym
The efficacy of Mesarazine drugs treatment for clinical relapse in ulcerative colitis patients, compared 3600mg of Asacolo(r) with 4000mg Pentasa(r)
Region
| Japan |
Condition
Condition
Ulcerative colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparing the efficacy of Asacolo with Pentasa.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
CAI score
EI score
Endoscopic examination( biopsy)
Blood test
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Oral administration of Asacolo 3600mg/day
or Pentasa 4000mg/day
Interventions/Control_2
Oral administration of Asacolo 3600mg/day
or Pentasa 4000mg/day
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
| 99 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The relapse UC patients with oral intake of Asacolol less than 3600mg/day or Pentasa less than 4000mg.
Agreement about this study
Over 16 years
Key exclusion criteria
Over daily ten times of diarhea
The patients who are considerd inapproval for this study by their outhospital doctors
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hidemi Goto |
Organization
NAGOYA UNIVERSITY GRADUATE SCHOOL OF MEDICINE
Division name
Gastroenterology and Hepatology
Zip code
Address
Tsurumai 65 Showaku Nagoya city Aichi prefecture Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Gastroenterology and Hepatology
Division name
Gastroenterology1
Zip code
Address
TEL
Homepage URL
mmatusita@med.nagoya-u.ac.jp
Sponsor or person
Institute
NAGOYA UNIVERSITY GRADUATE SCHOOL OF MEDICINE
Institute
Department
Personal name
Funding Source
Organization
NAGOYA 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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 02 | Month | 05 | 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
Preinitiation
Date of protocol fixation
| 2012 | Year | 02 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 03 | Month | 01 | 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 | 02 | Month | 03 | Day |
Last modified on
| 2013 | Year | 02 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011642
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
