UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012959 |
|---|---|
| Receipt number | R000015152 |
| Scientific Title | Comparison of the diagnostic tests for the diagnosis of Helicobacter pylori infection in patients without previous eradication therapy. |
| Date of disclosure of the study information | 2014/01/31 |
| Last modified on | 2017/07/30 21:00:33 |
* 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
Comparison of the diagnostic tests for the diagnosis of Helicobacter pylori infection in patients without previous eradication therapy.
Acronym
Comparison of the diagnostic tests for the diagnosis of Helicobacter pylori infection.
Scientific Title
Comparison of the diagnostic tests for the diagnosis of Helicobacter pylori infection in patients without previous eradication therapy.
Scientific Title:Acronym
Comparison of the diagnostic tests for the diagnosis of Helicobacter pylori infection.
Region
| Japan |
Condition
Condition
Patients with suspicious infection of Helicobacter pylori.
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate the efficacy of the diagnostic tests for Helicobacter pylori infection in patient without previous eradication therapy with special reference to false negative rates of a rapid urease test in patients taking a proton pump inhibitor.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
False negative rates of a rapid urease test in patients taking a proton pump inhibitor.
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
Diagnosis
Type of intervention
| Maneuver | Other |
Interventions/Control_1
Endoscopic biopsy, rapid urease test, urea breath test, and blood sampling.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with suspicious infection of Helicobacter pylori.
Key exclusion criteria
The exclusion criteria included previous eradication therapy and any contraindication for esophagogastroduodenoscopy.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenji Tominaga. |
Organization
Toho University Ohashi Medical Center.
Division name
Division of Gastroenterology and Hepatology, Department of Internal Medicine.
Zip code
Address
2-17-6 Ohashi, Meguro-ku, Tokyo 153-8515, Japan.
TEL
03-3468-1251
kenjitominaga@hotmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenji Tominaga. |
Organization
Toho University Ohashi Medical Center.
Division name
Division of Gastroenterology and Hepatology, Department of Internal Medicine.
Zip code
Address
2-17-6 Ohashi, Meguro-ku, Tokyo 153-8515, Japan.
TEL
03-3468-1251
Homepage URL
kenjitominaga@hotmail.com
Sponsor or person
Institute
Division of Gastroenterology and Hepatology, Department of Internal Medicine, Toho University Ohashi Medical Center.
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
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
東邦大学医療センター大橋病院(東京都)
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 01 | Month | 31 | 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
| 2014 | Year | 01 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 02 | Month | 01 | 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
| 2014 | Year | 01 | Month | 25 | Day |
Last modified on
| 2017 | Year | 07 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015152
