UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparison of rectal with oral mesalazine in the treatment of Ulcerative Proctitis (CORRECT Study)
Title of the study (Brief title)	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	Shingo Kato
Organization	Saitama Medical Center, Saitama Medical University
Division name	Department of Gastroenterology and Hepatology
Address	1981 Kamoda, Kawagoe City, Saitama 350-8550, Japan
TEL	049-228-3564
Email	skato@saitama-med.ac.jp

Public contact
Name of contact person	Shingo Kato
Organization	Saitama Medical Center, Saitama Medical University
Division name	Department of Gastroenterology and Hepatology
Address	1981 Kamoda, Kawagoe City, Saitama, Japan
TEL	049-228-3564
Homepage URL
Email	skato@saitama-med.ac.jp

Sponsor
Institute	Saitama Medical Center, Saitama Medical University
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 05 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012106