UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011236 |
|---|---|
| Receipt number | R000013167 |
| Scientific Title | Evaluation of efficacy of mesalazine suppository in ulcerative colitis with rectal inflammation -Efficacy of on-demand therapy for induction and maintenance of remission - |
| Date of disclosure of the study information | 2013/07/20 |
| Last modified on | 2016/01/20 15:05:59 |
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Basic information
Public title
Evaluation of efficacy of mesalazine suppository in ulcerative colitis with rectal inflammation -Efficacy of on-demand therapy for induction and maintenance of remission -
Acronym
Evaluation of efficacy of mesalazine suppository in ulcerative colitis with rectal inflammation
Scientific Title
Evaluation of efficacy of mesalazine suppository in ulcerative colitis with rectal inflammation -Efficacy of on-demand therapy for induction and maintenance of remission -
Scientific Title:Acronym
Evaluation of efficacy of mesalazine suppository in ulcerative colitis with rectal inflammation
Region
| Japan |
Condition
Condition
Ulcerative colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To prospectively evaluate efficacy of mesalazine suppository in Japanese ulcerative colitis patients with active rectal inflammation
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Time to disappearance of rectal bleeding
Rate of disappearance of rectal bleeding
Rate of adverse events
Key secondary outcomes
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
Upon appearance of rectal bleeding, once daily administration of a 500 mg mesalazine suppository until disappearance of rectal bleeding.
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Ulcerative colitis patients with rectal inflammation who has rectal bleeding or in remission.
2. Patients with the first attack or those in remission on salazopyrine or mesalazine less than 4 grams daily.
Key exclusion criteria
1. Past history of adverse effect to mesalazine.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Katsuyoshi Matsuoka |
Organization
Keio University School of Medicine
Division name
Gastroenterology and Hepatology
Zip code
Address
35 Shinanomachi, Shinjuku Tokyo
TEL
03-3353-122
matsuoka@z2.keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Katsuyoshi Matsuoka |
Organization
Keio University School of Medicine
Division name
Gastroenterlogy and Hepatology
Zip code
Address
35 Shinanomachi, Shinjuku Tokyo
TEL
03-3353-1211
Homepage URL
matsuoka@z2.keio.jp
Sponsor or person
Institute
Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine
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
| 2013 | Year | 07 | Month | 20 | 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
| 2011 | Year | 05 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 05 | Month | 02 | 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 | 07 | Month | 20 | Day |
Last modified on
| 2016 | Year | 01 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013167
