Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00162877
Status:
UNKNOWN
Last Update Posted:
2005-11-23
First Post:
2005-09-12
Brief Title:
The Role of CYP2C19 on the Eradication of H Pylori InfectionImplication of PKPD Relationships
Sponsor:
National Taiwan University Hospital
Organization:
National Taiwan University Hospital
Study Overview
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 PKPD Relationships
Status:
UNKNOWN
Status Verified Date:
2004-01
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 PKPD 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 PKPD of PPIs are also evaluated
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NTUH93S060 | None | None | None |