- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00197457
Pepsinogens as the Early Marker of H. Pylori Eradication
January 31, 2006 updated by: Hamamatsu University
Serum Pepsinogens as an Early Diagnostic Marker of H. Pylori Eradication
Helicobacter pylori (H.
pylori) eradication increases the serum pepsinogen (PG) I/PG II ratio and the percentage change in PG I/PG II ratios was found to be a useful marker of H. pylori eradication (e.g., the PG method).
We studied whether the PG method could be an early diagnostic marker of H. pylori eradication even in patients persistently treated with a proton pump inhibitor.
Sixty-two H. pylori-positive patients underwent H. pylori-eradication therapy, followed by treatment with a PPI to cure ulcers.
Serum levels of PG I and PG II were measured before, at the end of, and at 4 weeks after the eradication therapy.
At more than one month after the end of treatments, 13C-urea breath test (UBT) was performed.
The cut-off values of percentage changes in PG I/PG II ratios for the diagnosis of eradication of H. pylori were set in proportion to PG I/PG II ratios before eradication in accordance with our previous report.
Using the results of UBT as the standard, the percentage change in serum PG I/PG II ratios is useful as an early diagnostic marker for judgment of H. pylori eradication irrespective of PPI treatment.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Shizuoka
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Hamamatsu, Shizuoka, Japan, 431-3192
- Hamamatsu University School of Medicine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients with H. pylori infection
Exclusion Criteria:
- Patients without H. pylori infection
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Whether the serum pepsinogen could be an early diagnostic marker of H. pylori eradication even in patients persistently treated with a proton pump inhibitor compared with 13C-urea breath test.
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Secondary Outcome Measures
Outcome Measure |
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Cost-effectiveness for diagnosis of H. pylori eradication by the serum pepsinogen.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Naohito Shirai, MD., PhD., Hamamatsu University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2001
Study Registration Dates
First Submitted
September 12, 2005
First Submitted That Met QC Criteria
September 12, 2005
First Posted (Estimate)
September 20, 2005
Study Record Updates
Last Update Posted (Estimate)
February 1, 2006
Last Update Submitted That Met QC Criteria
January 31, 2006
Last Verified
May 1, 2001
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- pepsinogen2005
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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