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Register:	JPRN
Last refreshed on:	17 October 2023
Main ID:	JPRN-UMIN000010340
Date of registration:	01/04/2013
Prospective Registration:	Yes
Primary sponsor:	Saitama Medical Center, Saitama Medical University
Public title:	Comparison of rectal with oral mesalazine in the treatment of Ulcerative Proctitis (CORRECT Study)
Scientific title:	Comparison of rectal with oral mesalazine in the treatment of Ulcerative Proctitis (CORRECT Study) - CORRECT Study
Date of first enrolment:	2013/05/01
Target sample size:	60
Recruitment status:	Complete: follow-up complete
URL:	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012106
Study type:	Interventional
Study design:	Parallel Randomized
Phase:	Not selected

Countries of recruitment
Japan

Contacts

Name:	Shingo Kato
Address:	1981 Kamoda, Kawagoe City, Saitama 350-8550, Japan Japan
Telephone:	049-228-3564
Email:	skato@saitama-med.ac.jp
Affiliation:	Saitama Medical Center, Saitama Medical University Department of Gastroenterology and Hepatology

Name:	Shingo Kato
Address:	1981 Kamoda, Kawagoe City, Saitama, Japan Japan
Telephone:	049-228-3564
Email:	skato@saitama-med.ac.jp
Affiliation:	Saitama Medical Center, Saitama Medical University Department of Gastroenterology and Hepatology

Key inclusion & exclusion criteria

Inclusion criteria:
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

Age minimum: 18years-old
Age maximum: Not applicable
Gender: Male and Female

Health Condition(s) or Problem(s) studied

Ulcerative colitis

Intervention(s)

Randomized treatment with mesalazine suppository or oral mesalazine for 2 weeks
Switch from oral mesalazine to mesalazine suppository for 2 weeks

Primary Outcome(s)

Dissapearance rates of bloody stool on week 2

Secondary Outcome(s)

Secondary ID(s)

Source(s) of Monetary Support

Saitama Medical Center, Saitama Medical University

Secondary Sponsor(s)

Ethics review

Status: YES
Approval date:
Contact:

Results

Results available:
Date Posted:
Date Completed:
URL:

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