UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000009265
Receipt No. R000008950
Scientific Title The efficacy of azithromycin for the treatment of nonalcoholic steatohepatitis accompanied with Porphyromonas.gingivalis infection in the liver-Randomized controlled trial
Date of disclosure of the study information 2012/11/10
Last modified on 2019/03/07

* 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 efficacy of azithromycin for the treatment of nonalcoholic steatohepatitis accompanied with Porphyromonas.gingivalis infection in the liver-Randomized controlled trial
Acronym The efficacy of azithromycin for the treatment of nonalcoholic steatohepatitis accompanied with Porphyromonas.gingivalis infection in the liver-Randomized controlled trial
Scientific Title The efficacy of azithromycin for the treatment of nonalcoholic steatohepatitis accompanied with Porphyromonas.gingivalis infection in the liver-Randomized controlled trial
Scientific Title:Acronym The efficacy of azithromycin for the treatment of nonalcoholic steatohepatitis accompanied with Porphyromonas.gingivalis infection in the liver-Randomized controlled trial
Region
Japan

Condition
Condition nonalcoholic fatty liver disease/nonalcoholic steatohepatitis
Classification by specialty
Hepato-biliary-pancreatic medicine Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To demonstrate the efficacy and safety of azithromycin for the treatment of nonalcoholic fatty liver disease/nonalcoholic steatohepatitis accompanied with Porphyromonas.gingivalis infection in the liver
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase III

Assessment
Primary outcomes improvement of liver function test
Key secondary outcomes improvement of histological findings of the liver

Base
Study type Interventional

Study design
Basic design Factorial
Randomization Randomized
Randomization unit Individual
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 medical drug
Interventions/Control_2 placebo
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
80 years-old >
Gender Male and Female
Key inclusion criteria 1, NAFLD/NASH with P.gingivalis infection in the liver
2, Patients between 20 years old and older than that, and age less than 80 years old.
3, Patients who agreed to participate in this study.
Key exclusion criteria 1, Patients with alcoholic liver diseases.
2,Patients with viral liver diseases, autoimmune hepatitis, and primary biliary cirrhosis.
3, Paitents with pregnancy.
4, Patients who have allergy against ingredients of azithromicin.
5, Patients who have allergy against other macrolides and ketolides.
6, Patients with liver cirrhosis,liver failure including severe liver function test, hepatocellular carcinoma in the liver and other organs.
7, Patients with severe heart diseases.
8, Patients with hereditary fructose intolerance, glucose-galactose malabsorption, and sucrase-isomaltase deficiency.
9, Medical doctors decided the patients inappropriate.
Target sample size 44

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Kazuaki Chayama
Organization Hiroshima University Hospital
Division name Gastroenterology and Metabolism
Zip code
Address 1-2-3 Kasumi, Minamiku, Hiroshima, 734-8551, Japan
TEL 082-257-5191
Email

Public contact
1st name of contact person
1st name
Middle name
Last name Hideyuki Hyogo
Organization Hiroshima University Hospital
Division name Gastroenterology and Metabolism
Zip code
Address
TEL
Homepage URL
Email hidehyogo@hiroshima-u.ac.jp

Sponsor
Institute Hiroshima University Hospital
Institute
Department

Funding Source
Organization self funding
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 広島大学病院(広島県)

Other administrative information
Date of disclosure of the study information
2012 Year 11 Month 10 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 Terminated
Date of protocol fixation
2012 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 11 Month 10 Day
Last follow-up date
2014 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 11 Month 05 Day
Last modified on
2019 Year 03 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008950

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.