UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The usefulness of sulphasalazine for patients with ulcerative colitis refractory to mesalazine
Title of the study (Brief title)	The usefulness of sulphasalazine for patients with ulcerative colitis refractory to mesalazine
Region	Japan

Condition
Condition	ulcerative colitis
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to evaluate the usefulness of SASP for UC patient refractory to mesalazine.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The primary outcome was the induction-remission rate of UC patients refractory to mesalazine after initiating treatment with SASP.
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	90 years-old >=
Gender	Male and Female
Key inclusion criteria	From April 2010 to August 2015, 316 UC patients who had been treated at Kitano hospital were analyzed, retrospectively. Out of 316 UC patients, 32 (10.1%) with mesalazine-refractory UC who were treated with SASP were enrolled in this study. Mesalazine-refractory UC was defined as sustaining active-UC despite treatment with full-dose of oral mesalazine. The diagnosis of UC was confirmed by endoscopic and pathologic findings.
Key exclusion criteria	Exclusion criteria was defined as other than taht above.
Target sample size	32

Research contact person
Name of lead principal investigator	Takuya Yoshino
Organization	Kitano Hospital
Division name	Digestive Disease Center
Address	2-4-20, Ohgimachi, Kita-ku, Osaka, Japan
TEL	06-6312-1221
Email	t-yoshino@kitano-hp.or.jp

Public contact
Name of contact person	Takuya Yoshino
Organization	Kitano Hospital
Division name	Digestive Disease Center
Address	2-4-20, Ohgimachi, Kita-ku, Osaka, Japan
TEL	06-6312-1221
Homepage URL
Email	t-yoshino@kitano-hp.or.jp

Sponsor
Institute	Digestive Disease Center, Kitano Hospital
Institute
Department

Funding Source
Organization	Digestive Disease Center, Kitano Hospital
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	2016 Year 04 Month 01 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2010 Year 04 Month 01 Day
Anticipated trial start date	2010 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	http://bmjopengastro.bmj.com/doi/10.1136/bmjgast-2016-000103
Results
Other related information	Study design: Retrospecitve cohort study Patients: From April 2010 to August 2015, 316 UC patients treated at Kitano hospital were retrospectively analyzed. Of the 316 UC patients, 32 (10.1%) with mesalazine-refractory UC who were treated with SASP were enrolled in the study. Factors:gender, age, disease duration, extent of disease, clinical activity, endoscopic activity, medications, history of steroid, adverse event

Management information
Registered date	2016 Year 03 Month 25 Day
Last modified on	2017 Year 03 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024928