UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045798 |
|---|---|
| Receipt number | R000048851 |
| Scientific Title | A RANDOMIZED TRIAL OF CLARITHROMYCIN 800 mg VERSUS 400 mg AS PART OF FIRST-LINE TRIPLE THERAPY |
| Date of disclosure of the study information | 2021/10/21 |
| Last modified on | 2021/10/19 22:54:36 |
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Basic information
Public title
A Randomized controlled trial of clarithromycin 800 mg versus 400 mg as part of first-line triple therapy with vonoprazan for Helicobacter pylori gastritis
Acronym
A RANDOMIZED TRIAL OF CLARITHROMYCIN 800 mg VERSUS 400 mg AS PART OF FIRST-LINE TRIPLE THERAPY
Scientific Title
A RANDOMIZED TRIAL OF CLARITHROMYCIN 800 mg VERSUS 400 mg AS PART OF FIRST-LINE TRIPLE THERAPY
Scientific Title:Acronym
A RANDOMIZED TRIAL OF CLARITHROMYCIN 800 mg VERSUS 400 mg AS PART OF FIRST-LINE TRIPLE THERAPY
Region
| Japan |
Condition
Condition
Helicobacter pylori gastritis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the eradication rate of clarithromycin doses of 400 mg and 800 mg in the first-line triple therapy using vonoprazan for Helicobacter pylori gastritis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase IV
Assessment
Primary outcomes
Eradication rate of the first-line therapy assessed by a urea breath test from 8 to 12 weeks after cessation of therapy.
Key secondary outcomes
Effects of clarithromycin resistance, eGFR, alcohol consumption, and smoking on the eradication rate of each group, and the incidence and severity of adverse events
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Dose comparison
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Vonoprazan (VPZ) 20mg, Amoxicillin (ABPC) 750mg, Clarithromycin (CAM) 200mg, for the first 7days, with all drugs given twice daily
Interventions/Control_2
VPZ 20mg, ABPC 750mg, CAM 400mg, for the first 7days, with all drugs given twice daily
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who received a diagnosis of Helicobacter pylori gastritis by any one method of a rapid urease test, a urea breath test, a blood antibody test, a stool antigen test, and microbial culture.
Key exclusion criteria
1. Patients who have histories of eradication therapy for Helicobacter pylori.
2. Patients who received any one of lansoprazole, esomeprazole, omeprazole, and vonoprazan within 2 weeks.
3. Patients who suggested or received a diagnosis of other infectious diseases.
4. Patients being treated for acute gastritis, advanced gastric cancer, and gastric MALT lymphoma.
5. Patients after gastrectomy.
6. Patients who have coexisting severe heart disease, liver disease, respiratory disease, metabolic disease, neuromuscular disease, and severe chronic renal failure (estimated glomerular filtration rate [eGFR] <30 mL/min/1.73 m2).
7. Patients who have a past history of allergy for vonoprazan, esomeprazole, amoxicillin, and clarithromycin.
8. Pregnancy or lactating women.
9. Patients requiring hospitalization..
Target sample size
516
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Tamaki |
Organization
Takamatsu Red Cross Hospital
Division name
Department of gastroenterology
Zip code
7600017
Address
4-1-3, Ban-cho, Takamatsu , Kagawa, Japan
TEL
087-831-7101
h-tama@gc4.so-net.ne.jp
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Tamaki |
Organization
Takamatsu Red Cross Hospital
Division name
Department of gastroenterology
Zip code
7600017
Address
4-1-3, Ban-cho, Takamatsu , Kagawa, Japan
TEL
0878317101
Homepage URL
h-tama@gc4.so-net.ne.jp
Sponsor or person
Institute
Takamatsu Red Cross Hospital
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
Takamatsu Red Cross Hospital
Address
4-1-3, Ban-cho, Takamatsu, Kagawa, Japan
Tel
0878317101
tamaki33@gmail.com
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
| 2021 | Year | 10 | Month | 21 | 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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 04 | Month | 10 | Day |
Date of IRB
| 2017 | Year | 04 | Month | 18 | Day |
Anticipated trial start date
| 2017 | Year | 05 | Month | 13 | Day |
Last follow-up date
| 2022 | Year | 05 | Month | 13 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 10 | Month | 19 | Day |
Last modified on
| 2021 | Year | 10 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048851
