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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000021615
Receipt No. R000024928
Scientific Title The usefulness of sulphasalazine for patients with ulcerative colitis refractory to mesalazine
Date of disclosure of the study information 2016/04/01
Last modified on 2017/03/26

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Basic information
Public title The usefulness of sulphasalazine for patients with ulcerative colitis refractory to mesalazine
Acronym The usefulness of sulphasalazine for patients with ulcerative colitis refractory to mesalazine
Scientific Title The usefulness of sulphasalazine for patients with ulcerative colitis refractory to mesalazine
Scientific Title:Acronym 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
1st name
Middle name
Last name Takuya Yoshino
Organization Kitano Hospital
Division name Digestive Disease Center
Zip code
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
1st name
Middle name
Last name Takuya Yoshino
Organization Kitano Hospital
Division name Digestive Disease Center
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://bmjopengastro.bmj.com/doi/10.1136/bmjgast-2016-000103
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 Main results already published
Date of protocol fixation
2010 Year 04 Month 01 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000024928

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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