Peptic Ulcer With H. Pylori InfectionNCT00162877
The Role of CYP2C19 on the Eradication of H. Pylori Infection:Implication of PK/PD Relationships
A study testing Rabeprazole vs. Esomeprazole in people with Peptic Ulcer With H. Pylori Infection and Gastritis With H. Pylori Infection, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The objective of this trial is to find the rationale and the optimal dose and duration of regimen for the eradication of H. pylori infection using different proton pump inhibitors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peptic Ulcer With H. Pylori Infection, Gastritis With H. Pylori Infection
- What is being tested?
- Rabeprazole vs. Esomeprazole
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- Jun 2004to Apr 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female dyspeptic patients with H. pylori-positive peptic ulcer or gastritis will be recruited at the university hospital in this study.
Who cannot join
- 1)Pregnant or lactating female;*2)Patients have endoscopy-based evidence of gastric malignancy, pyloric obstruction, and esophageal stricture requiring dilation, fresh clot, active bleeding, or perforated ulcers;3)Patients requiring anticoagulants or corticosteroid therapy (at dosages greater than the equivalent of prednisone, 10 mg/day);4)Patients with significant impairment of renal function (creatinine>2mg/dl); liver function impairment (AST and ALT 2x upper limit of normal); severe cardiac disease, e.g. angina pectoris, myocardial infarction, cardiac arrhythmia, congestive heart failure (New York Heart Association Functional Classification III and IV) or acute respiratory disease;5)Patients with a history of esophageal and/or gastric varices;6)Use of other investigational drugs within 30 days prior to the study.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Department of Internal Medicine, National Taiwan University Hospital
Taipei, 100
About this study
Official title: The Role of CYP2C19 Poor Metabolizers and Extensive Metabolizers of PPI in Short-Term Triple Therapy on the Eradication of H. Pylori Infection: Implication of PK/PD Relationships
The objective of this trial is to find the rationale and the optimal dose and duration of regimen for the eradication of H. pylori infection using different proton pump inhibitors.
Read the detailed description
Helicobacter pylori in known to be closely associated with the pathogenesis of gastroduodenal disorders such as peptide ulcer. Eradication of this bacterium is important in the treatment of these diseases as well as in the reduction of the recurrence. The one-week triple therapy with proton pump inhibitors (PPIs) is now considered to be the standard therapies in the treatment of Helicobacter pylori infection, providing more than 80% eradication rates with few adverse effects. PPIs are mainly metabolized by CYP2C19, which is known to exhibit polymorphisms in both its genotype and phenotype. Based on the PK/PD results of our study on PPI, recently, we have proposed that CYP2C19 poor metabolizers might be subject to advantageous conditions, especially after day-4, for the treatment of H. pylori infection when 20 mg rabeprazole was given twice daily. Our results also suggest a possibility to start the triple therapy on day-4 of rabeprazole treatment to ensure the optimal acid suppression effect for antibiotics to exert the bacteriocidal effect. To find the rationale and the optimal dosing regimen for the eradication of H. pylori infection using different proton pump inhibitors, volunteers of four groups would be included in this study. PPI (rabeprazole or esomeprazole) is given for 7 days. Antibiotics are given starting from day-1 or day-4 of PPI dosing. The eradication rate of H. pylori infection and the PK/PD of PPIs are also evaluated.
- Being tested
- Rabeprazole vs. Esomeprazole
- Keywords
- rabeprazole, omeprazole, CYP2C19, H. pylori, PK/PD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rabeprazole vs. EsomeprazoleDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
the role of CYP2C19 on the eradication of H. pylori infection
Secondary outcomes (1)
implication of PK/PD relationships
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2005 (estimated)
- Study startJun 2004
- Study completionApr 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peptic Ulcer With H. Pylori InfectionStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 80 participants
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Jyh-Chin Yang, M.D., Principal investigator, Department of Internal Medicine, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00162877
- Sponsor's protocol ID
- 920505
- Other IDs
- NTUH93S060
- Status last verified
- Jan 2004
- First submitted
- 12 Sep 2005
- Last updated
- 23 Nov 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of CYP2C19 Poor Metabolizers and Extensive Metabolizers of PPI in Short-Term Triple Therapy on the Eradication of H. Pylori Infection: Implication of PK/PD Relationships
- ClinicalTrials.gov ID
- NCT00162877
- Acronym / sponsor ID
- 920505
- Keywords
- rabeprazole, omeprazole, CYP2C19, H. pylori, PK/PD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jun 2004
- Study completion
- Apr 2005
- First posted
- 13 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this trial is to find the rationale and the optimal dose and duration of regimen for the eradication of H. pylori infection using different proton pump inhibitors.
Detailed description
Helicobacter pylori in known to be closely associated with the pathogenesis of gastroduodenal disorders such as peptide ulcer. Eradication of this bacterium is important in the treatment of these diseases as well as in the reduction of the recurrence. The one-week triple therapy with proton pump inhibitors (PPIs) is now considered to be the standard therapies in the treatment of Helicobacter pylori infection, providing more than 80% eradication rates with few adverse effects. PPIs are mainly metabolized by CYP2C19, which is known to exhibit polymorphisms in both its genotype and phenotype. Based on the PK/PD results of our study on PPI, recently, we have proposed that CYP2C19 poor metabolizers might be subject to advantageous conditions, especially after day-4, for the treatment of H. pylori infection when 20 mg rabeprazole was given twice daily. Our results also suggest a possibility to start the triple therapy on day-4 of rabeprazole treatment to ensure the optimal acid suppression effect for antibiotics to exert the bacteriocidal effect. To find the rationale and the optimal dosing regimen for the eradication of H. pylori infection using different proton pump inhibitors, volunteers of four groups would be included in this study. PPI (rabeprazole or esomeprazole) is given for 7 days. Antibiotics are given starting from day-1 or day-4 of PPI dosing. The eradication rate of H. pylori infection and the PK/PD of PPIs are also evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Male and female dyspeptic patients with H. pylori-positive peptic ulcer or gastritis will be recruited at the university hospital in this study.
Key exclusion criteria (1 listed)
- 1)Pregnant or lactating female;*2)Patients have endoscopy-based evidence of gastric malignancy, pyloric obstruction, and esophageal stricture requiring dilation, fresh clot, active bleeding, or perforated ulcers;3)Patients requiring anticoagulants or corticosteroid therapy (at dosages greater than the equivalent of prednisone, 10 mg/day);4)Patients with significant impairment of renal function (creatinine>2mg/dl); liver function impairment (AST and ALT 2x upper limit of normal); severe cardiac disease, e.g. angina pectoris, myocardial infarction, cardiac arrhythmia, congestive heart failure (New York Heart Association Functional Classification III and IV) or acute respiratory disease;5)Patients with a history of esophageal and/or gastric varices;6)Use of other investigational drugs within 30 days prior to the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rabeprazole vs. Esomeprazole | Drug | – |
Primary outcome
the role of CYP2C19 on the eradication of H. pylori infection
1 secondary outcome
implication of PK/PD relationships
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jyh-Chin Yang, M.D. principal investigator
Department of Internal Medicine, National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rabeprazole vs. Esomeprazole in people with Peptic Ulcer With H. Pylori Infection and Gastritis With H. Pylori Infection, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Nov 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the role of CYP2C19 on the eradication of H. pylori infection. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2005.