UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021615 |
|---|---|
| Receipt number | 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 09:54:40 |
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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
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
t-yoshino@kitano-hp.or.jp
Sponsor or person
Institute
Digestive Disease Center, Kitano Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024928
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
