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Recruitment status Main results already published
Unique ID issued by UMIN UMIN000004201
Receipt No. R000005048
Scientific Title The evaluation of efficacy for remission maintenance with immunomodulator following remission induction with tacrolimus in patients with moderate to severe active refractory ulcerative colitis.:mucosal healing for prognosis
Date of disclosure of the study information 2010/09/14
Last modified on 2018/09/20

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Basic information
Public title The evaluation of efficacy for remission maintenance with immunomodulator following remission induction with tacrolimus in patients with moderate to severe active refractory ulcerative colitis.:mucosal healing for prognosis
Acronym Hyogo College of Medicine, Osaka Medical College, Osaka City University Project 1, Tacrolimus-Ulcerative Colitis, 3 [Mucosal Healing for Prognosis]
: HOOP1 (TCL-UC)-3 [MHP]
Scientific Title The evaluation of efficacy for remission maintenance with immunomodulator following remission induction with tacrolimus in patients with moderate to severe active refractory ulcerative colitis.:mucosal healing for prognosis
Scientific Title:Acronym Hyogo College of Medicine, Osaka Medical College, Osaka City University Project 1, Tacrolimus-Ulcerative Colitis, 3 [Mucosal Healing for Prognosis]
: HOOP1 (TCL-UC)-3 [MHP]
Region
Japan

Condition
Condition The patients with moderate to severe active refractory ulcerative colitis
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The evaluation of efficacy for remission maintenance with immunomodulator following remission induction with tacrolimus in patients with moderate to severe active refractory ulcerative colitis.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Remission rate at 48 weeks after the administration of tacrolimus
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Group of remission maintenance therapy for 48 weeks with immunomodulator at from 2 to 4 weeks following remission induction with tacrolimus,
Interventions/Control_2 Group of no remission maintenance therapy with immunomodulator following remission induction with tacrolimus,
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
16 years-old <=
Age-upper limit
65 years-old >
Gender Male and Female
Key inclusion criteria 1)The patients with ulcerative colitis of left side colitis or pancolitis type
2)Moderate to severe active ulcerative colitis (more than 6 points for DAI)
3)Steroid refractory or dependent case
Key exclusion criteria 1)The treatment with immunomodulator or anti-TNF alpha agents within 12 weeks before administration of tacrolimus
2)The treatment with cytapheresis within 12 weeks before administration of tacrolimus
3)The patients who are not suitable for treatment of immunomodulator
4)The patients after colectomy
5)the patients with renal disorder
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kenji Watanabe
Organization Osaka City University, Graduate School of Medicine
Division name Gastroenterology
Zip code
Address 1-4-3, Asahi-machi, Abeno-ku, Osaka
TEL 0666453811
Email kenjiw@med.osaka-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kenji Watanabe
Organization Osaka City University, Graduate School of Medicine
Division name Gastroenterology
Zip code
Address 1-4-3, Asahi-machi, Abeno-ku, Osaka
TEL 0666453811
Homepage URL
Email kenjiw@med.osaka-cu.ac.jp

Sponsor
Institute Osaka City University, Graduate School of Medicine,Department of Gastroenterology
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
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 YES
Study ID_1 1772
Org. issuing International ID_1 Ethical Committee of Osaka City University, Graduate School of Medicine
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 大阪市立大学病院(大阪府)、兵庫医科大学病院(兵庫県)、大阪医科大学病院(大阪府)

Other administrative information
Date of disclosure of the study information
2010 Year 09 Month 14 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
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
2013 Year 08 Month 29 Day
Date of IRB
Anticipated trial start date
2013 Year 12 Month 02 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 09 Month 14 Day
Last modified on
2018 Year 09 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005048

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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