UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000021411
Receipt No. R000024696
Scientific Title clinical efficacy of oral administration of metronidazole in the treatment of primary sclerosing cholangitis
Date of disclosure of the study information 2016/04/01
Last modified on 2019/09/10

* 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 clinical efficacy of oral administration of metronidazole in the treatment of primary sclerosing cholangitis
Acronym clinical efficacy of oral administration of metronidazole in the treatment of PSC
Scientific Title clinical efficacy of oral administration of metronidazole in the treatment of primary sclerosing cholangitis
Scientific Title:Acronym clinical efficacy of oral administration of metronidazole in the treatment of PSC
Region
Japan

Condition
Condition primary sclerosing cholangitis
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We aim to evaluate the efficacy and the safety of oral administration of metronidazole for 12 weeks during the administration period and subsequent 12 weeks following the cessation. Furthermore, We examine the interaction of gut microbiota and immune cells during the treatment, aiming to clarify the pathogenesis of PSC via gut-liver axis.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Serological improvement in the hepatobiliary function (serum ALP and total bilirubin) at 12weeks after the treatment
Key secondary outcomes Alteration of the intestinal flora during the treatment

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 Patients take metronidazole 250mg orally three times day for 3 weeks.
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
16 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Patients with a chronic cholestasis who are diagnosed as PSC with the specific findings by MRCP or ERCP
2. Patients with chronic liver injury or compensated liver cirrhosis (Child Pugh score below 9 point)
3. Presence or absence of the PSC-related colitis does not matter for an entry
4. Patients elder than 16 years old who are consented in writing of the applicant
Key exclusion criteria Patients with a decompensated cirrhosis (Child Pugh score upper 10 point)
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nobuhiro Nakamoto
Organization Keio University, School of Medicine
Division name Division of Gastroenterology and Hepatology
Zip code
Address 35 Shinanomachi Shinjuku-ku, Tokyo
TEL +81-3-3353-1211
Email nobuhiro@z2.keio.jp

Public contact
Name of contact person
1st name
Middle name
Last name Nobuhiro Nakamoto
Organization Keio University, School of Medicine
Division name Division of Gastroenterology and Hepatology
Zip code
Address 35 Shinanomachi Shinjuku-ku, Tokyo
TEL +81-3-3353-1211
Homepage URL
Email nobuhiro@z2.keio.jp

Sponsor
Institute Keio University, School of Medicine
Institute
Department

Funding Source
Organization Keio University, School 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
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 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
2016 Year 01 Month 01 Day
Date of IRB
2016 Year 02 Month 22 Day
Anticipated trial start date
2016 Year 04 Month 01 Day
Last follow-up date
2019 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
2016 Year 03 Month 09 Day
Last modified on
2019 Year 09 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024696

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.