UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010668 |
|---|---|
| Receipt number | R000012477 |
| Scientific Title | Examination on mucosal healing in mild to moderate active ulcerative colitis with mesalazine: a multicentre prospective open study |
| Date of disclosure of the study information | 2013/05/08 |
| Last modified on | 2015/05/10 16:54:20 |
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Basic information
Public title
Examination on mucosal healing in mild to moderate active ulcerative colitis with mesalazine: a multicentre prospective open study
Acronym
EXACT Study
Scientific Title
Examination on mucosal healing in mild to moderate active ulcerative colitis with mesalazine: a multicentre prospective open study
Scientific Title:Acronym
EXACT Study
Region
| Japan |
Condition
Condition
Ulcerative colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate mucosal healing effects of mesalazine in patients with mild to moderate active ulcerative colitis and to study effects of the timing to achieve mucosal healing on their long-term outcomes.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Mucosal healing rate at 12 weeks
Key secondary outcomes
Maintainance of remission with once-daily oral mesalazine in patients achieved mucosal healing.
Effect of long-term administration of oral mesalazine in patients with persistent endoscopically active UC.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Oral administration of Pentasa 4000mg/day
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Mild to moderate, active ulcerative colitis.
2.Adult outpatients.
3.Disease extent, disease duration, disease course and gender: No limitation.
4.Patients treated with immunomodulators: constant or decreasing dosage within 90 days before registration, and expected no dose increase in observation period.
5.Agreement in writing about this study.
Key exclusion criteria
1.Moderate, severe or fulminating active ulcerative colitis.
2.Use of oral 5-ASAs more than 4g/day within 2 weeks prior to study entry.
3.Introduce or increase the dosage of Steroids (intravenous infusion, oral), biologics or CAP within the last 90 days.
4.Increase the dosage of immunomodulators within the last 90 days.
5.Introduce or increase the treatment in the observation period.
6.Possible or documented pregnancy.
7.Experience of hypersensitivity to mesalazine.
8.Malignant disease or its history.
9.Patients who are considered inappropriate by investigators.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Keiichi Tominaga |
Organization
DOKKYO Medical University
Division name
Gastroenterology
Zip code
Address
880 Kitakobayashi Mibu Shimotsuga Tochigi, Japan
TEL
0282-86-1111
tominaga@dokkyomed.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Keiichi Tominaga |
Organization
DOKKYO Medical University
Division name
Gastroenterology
Zip code
Address
880 Kitakobayashi Mibu Shimotsuga Tochigi, Japan
TEL
0282-86-1111
Homepage URL
tominaga@dokkyomed.ac.jp
Sponsor or person
Institute
Dokkyo Medical University
Institute
Department
Personal name
Funding Source
Organization
none
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
獨協医科大学病院（栃木県）、群馬大学医学部附属病院（群馬県）、筑波大学附属病院（茨城県）、自治医科大学附属病院（栃木県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 05 | Month | 08 | 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
Terminated
Date of protocol fixation
| 2013 | Year | 04 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 05 | Month | 08 | Day |
Last follow-up date
| 2014 | Year | 11 | Month | 10 | Day |
Date of closure to data entry
| 2014 | Year | 11 | Month | 10 | Day |
Date trial data considered complete
| 2014 | Year | 11 | Month | 10 | Day |
Date analysis concluded
| 2014 | Year | 11 | Month | 10 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 05 | Month | 08 | Day |
Last modified on
| 2015 | Year | 05 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012477
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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