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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000010668
Receipt No. 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

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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
Email 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
Email tominaga@dokkyomed.ac.jp

Sponsor
Institute Dokkyo Medical University
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012477

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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