UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008352 |
|---|---|
| Receipt number | R000009822 |
| Scientific Title | Switch Trial from Several Times to Once Daily Oral Mesalazine Administration in Patients with Quiescent Ulcerative Colitis |
| Date of disclosure of the study information | 2012/08/01 |
| Last modified on | 2018/01/02 21:47:15 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Switch Trial from Several Times to Once Daily Oral Mesalazine Administration in Patients with Quiescent Ulcerative Colitis
Acronym
Once Daily Oral Mesalazine Swich Trial in UC-Patients
Scientific Title
Switch Trial from Several Times to Once Daily Oral Mesalazine Administration in Patients with Quiescent Ulcerative Colitis
Scientific Title:Acronym
Once Daily Oral Mesalazine Swich Trial in UC-Patients
Region
| Japan |
Condition
Condition
Ulcerative Colitis
Classification by specialty
| Medicine in general | Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of adherence and efficacy of maintenance of remission by switching from several times to once daily oral mesalazine administration in patients with quiescent ulcerative colitis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes of clinical activity index (CAI)in week 48
Key secondary outcomes
Changes of adherece in week 48
Changes of stool calprotectin concentration in week 48
Remission rates in week 48
Changes of CRP titer in week 48
Changes of stool number and bloody stoolin week 48
Safety
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
Switch from several times to once daily oral mesalazine administration
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
| 15 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who keeps remission state more than 8 weeks by several times oral mesarazine administration
CAI score is 4 and less
Patients who have informed consent
Key exclusion criteria
Patients refractory to oral mesalazine
Patients treated by infliximab within 12 weeks
Patients treated by azathiopurine and 6MP within 12 weeks
Patients treated by tacrolimus within 12 weeks
Patients treated by leukocyteapheresis within 12 weeks
Patients in maternity and lactation
Patients treated by surgery within 6 months
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shingo kato |
Organization
Saitama Medical Center, Saitama Medical University
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
1981, Kamoda, Kawagoe City, Saitama, Japan
TEL
049-228-3564
skato@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shingo Kato |
Organization
Saitama Medical Center, Saitama Medical University
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
1981 Kamoda, Kawagoe City, Saitama, Japan
TEL
049-228-3564
Homepage URL
skato@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical Center, Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
Saitama Medical Center, Saitama Medical University
Organization
Division
Category of Funding Organization
Other
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
| 2012 | Year | 08 | Month | 01 | 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
Completed
Date of protocol fixation
| 2012 | Year | 07 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 08 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2017 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 07 | Month | 05 | Day |
Last modified on
| 2018 | Year | 01 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009822
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
