UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010004 |
|---|---|
| Receipt number | R000011713 |
| Scientific Title | Safety and efficacy of Hange-shashin-to therapy for refractory pouchitis |
| Date of disclosure of the study information | 2013/02/09 |
| Last modified on | 2014/03/21 20:25:46 |
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Basic information
Public title
Safety and efficacy of Hange-shashin-to therapy for refractory pouchitis
Acronym
Hange-shashin-to for refractory pouchitis
Scientific Title
Safety and efficacy of Hange-shashin-to therapy for refractory pouchitis
Scientific Title:Acronym
Hange-shashin-to for refractory pouchitis
Region
| Japan |
Condition
Condition
pouchitis
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The topical applicability of Hange-shashin-to for refractory pouchitis will be investigated.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase I
Assessment
Primary outcomes
Efficacy of treatment was defined Pouchitis Disease Activity Index score with each parameter which includes clinical symptoms, endoscopic appearance, and histopathological findings. These parameters were assessed at before and after treatment.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Hange-shashin-to administration
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
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with chronic relapsing-remitting pouchitis after restorative proctocolectomy for ulcerative colitis.
PDAI scoreis more than7points.
Candidate has to agree to be enrolled for the study under sufficient written informed consent.
Key exclusion criteria
1)Concomitant administrations of antibiotics within 2weeks.
2)Concomitant administrations of Chinese medicine within 2weeks.
3) A patient, who is pregnant, may be pregnant, breast-feeds or hopes to be pregnant in the study period.
4) A patient who is determined as ineligible for a subject in this study by a doctor in charge or others.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroki Ikeuchi |
Organization
Hyogo college of Medicine
Division name
Lower gastroenterological surgery /IBD center
Zip code
Address
Mukogawa-cho 1-1, Nishinomiya city, Hyogo, Japan
TEL
0798-45-6372
ikeuci2s@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroki Matsuoka |
Organization
Hyogo college of Medicine
Division name
gastroenterological surgery
Zip code
Address
1-1 mukogawa-cho, Nishinomiya city, Hyogo, Japan
TEL
0798-45-6372
Homepage URL
m-hiro2s@hyo-med.ac.jp
Sponsor or person
Institute
Department of lower gastroenterological surgery, Hyogo college of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of lower gastroenterological surgery, Hyogo college of Medicine
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
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
| 2013 | Year | 02 | Month | 09 | 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
No longer recruiting
Date of protocol fixation
| 2013 | Year | 02 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 02 | Month | 12 | 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
| 2013 | Year | 02 | Month | 08 | Day |
Last modified on
| 2014 | Year | 03 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011713
