UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004201 |
|---|---|
| Receipt number | 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 | 2024/03/10 22:28:06 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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 | Kenji |
| Middle name | |
| Last name | Watanabe |
Organization
Osaka City University, Graduate School of Medicine
Division name
Gastroenterology
Zip code
545-8585
Address
1-4-3, Asahi-machi, Abeno-ku, Osaka
TEL
0666453811
kenjiw1779@gmail.com
Public contact
Name of contact person
| 1st name | Kenji |
| Middle name | |
| Last name | Watanabe |
Organization
Osaka City University, Graduate School of Medicine
Division name
Gastroenterology
Zip code
545-8585
Address
1-4-3, Asahi-machi, Abeno-ku, Osaka
TEL
0666453811
Homepage URL
kenjiw1779@gmail.com
Sponsor or person
Institute
Osaka City University, Graduate School of Medicine,Department of Gastroenterology
Institute
Department
Personal name
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
Ethical Committee of Osaka City University, Graduate School of Medicine
Address
1-4-3, Asahi-machi, Abeno-ku, Osaka
Tel
06-6646-6125
kenjiw1779@gmail.com
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
Completed
Date of protocol fixation
| 2013 | Year | 08 | Month | 29 | Day |
Date of IRB
| 2010 | Year | 06 | Month | 08 | Day |
Anticipated trial start date
| 2013 | Year | 12 | Month | 02 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
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
| 2024 | Year | 03 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005048
