UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009265 |
|---|---|
| Receipt number | 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 11:39:59 |
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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
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
Public contact
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
hidehyogo@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008950
