The Role of CYP2C19 on the Eradication of H. Pylori Infection:Implication of PK/PD Relationships - Full Text View

Sponsored by:	National Taiwan University Hospital
Information provided by:	National Taiwan University Hospital
ClinicalTrials.gov Identifier:	NCT00162877

Purpose

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.

Condition	Intervention
Peptic Ulcer With H. Pylori Infection Gastritis With H. Pylori Infection	Drug: Rabeprazole vs. Esomeprazole

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Crossover Assignment, Pharmacokinetics 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

Resource links provided by NLM:

MedlinePlus related topics: Peptic Ulcer

Drug Information available for: Omeprazole Omeprazole magnesium E 3810 Esomeprazole Sodium Esomeprazole magnesium

U.S. FDA Resources

Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:

the role of CYP2C19 on the eradication of H. pylori infection

Secondary Outcome Measures:

implication of PK/PD relationships

Estimated Enrollment:	80
Study Start Date:	June 2004
Estimated Study Completion Date:	April 2005

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male and female dyspeptic patients with H. pylori-positive peptic ulcer or gastritis will be recruited at the university hospital in this study.

Exclusion Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00162877

Locations

Taiwan
Department of Internal Medicine, National Taiwan University Hospital
Taipei, Taiwan, 100
Department of Internal Medicine, National Taiwan University Hospital
Taipei, Taiwan, 100

Sponsors and Collaborators

National Taiwan University Hospital

Investigators

Principal Investigator:

Jyh-Chin Yang, M.D.

Department of Internal Medicine, National Taiwan University Hospital

More Information

No publications provided

Study ID Numbers:	920505, NTUH93S060
Study First Received:	September 12, 2005
Last Updated:	November 22, 2005
ClinicalTrials.gov Identifier:	NCT00162877 History of Changes
Health Authority:	Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:

rabeprazole, omeprazole, CYP2C19, H. pylori, PK/PD

Study placed in the following topic categories:

Stomach Diseases
Digestive System Diseases
Gastrointestinal Diseases
Ulcer
Omeprazole
Intestinal Diseases

Gastroenteritis
Gastritis
Rabeprazole
Duodenal Diseases
Peptic Ulcer

Additional relevant MeSH terms:

Communicable Diseases
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Diseases
Gastrointestinal Agents
Omeprazole
Enzyme Inhibitors
Infection
Intestinal Diseases
Pharmacologic Actions

Digestive System Diseases
Stomach Diseases
Therapeutic Uses
Anti-Ulcer Agents
Gastroenteritis
Gastritis
Peptic Ulcer
Duodenal Diseases
Rabeprazole

ClinicalTrials.gov processed this record on September 11, 2009