UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010340 |
|---|---|
| Receipt number | R000012106 |
| Scientific Title | Comparison of rectal with oral mesalazine in the treatment of Ulcerative Proctitis (CORRECT Study) |
| Date of disclosure of the study information | 2013/04/01 |
| Last modified on | 2018/01/02 21:52:58 |
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Basic information
Public title
Comparison of rectal with oral mesalazine in the treatment of Ulcerative Proctitis
(CORRECT Study)
Acronym
CORRECT Study
Scientific Title
Comparison of rectal with oral mesalazine in the treatment of Ulcerative Proctitis
(CORRECT Study)
Scientific Title:Acronym
CORRECT Study
Region
| Japan |
Condition
Condition
Ulcerative colitis
Classification by specialty
| Gastroenterology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigation of the efficacy of mesalazine suppository to the patients with slight to moderate active ulcerative colitis in comparison with oral mesalazine
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Dissapearance rates of bloody stool on week 2
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
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
Randomized treatment with mesalazine suppository or oral mesalazine for 2 weeks
Interventions/Control_2
Switch from oral mesalazine to mesalazine suppository for 2 weeks
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients, more than 18 years old with active rectal type of ulcerative colitis
2. Patients treated with oral mesalazine drugs less than 2.4g for more than 2 weeks
3. Patients with active ulcerative colitis whose bloody stool scores are more than 1
4. Male or female, inpatients or outpatients will be permitted to be entered
Key exclusion criteria
1. Patients started to be treated with rectal 5-ASA and/or rectal steroids within 30 days before entry
2. Patients started to be treated with oral steroids within 14 days before entry
3. Patients with pregnancy or with the possibility of pregnancy
4. Patients with allergy of mesalazine and/or salicylic acid
5. Patients who have experienced severe side effects of mesalazine.
6. Patients with liver and/or renal dysfunctuon
7. Patinets with malignancy or with the history of malignancy
8. Patients induced in remission with biologics or cyteapheresis
9. Patients diagnosed not to be appropriate in entry by doctors
Target sample size
60
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 350-8550, 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
| 2013 | Year | 04 | 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
| 2013 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 05 | 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
| 2013 | Year | 03 | Month | 28 | 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=R000012106
