Ignite Creation Date:
2024-05-05 @ 10:11 PM
Last Modification Date:
2024-10-26 @ 10:14 AM
Study NCT ID:
NCT01042184
Status:
COMPLETED
Last Update Posted:
2012-11-16
First Post:
2010-01-03
Brief Title:
Efficacy of 10-day and 14-day Sequential Therapy Versus Triple Therapy on the Eradication of Helicobacter Pylori
Sponsor:
National Taiwan University Hospital
Organization:
National Taiwan University Hospital
Study Overview
Official Title:
Phase IV Study Comparing the Duration of Sequential Therapy
Status:
COMPLETED
Status Verified Date:
2012-06
Last Known Status:
None
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:
Background Helicobacter pylori infection has been shown to be associated with the development of gastric cancer and peptic ulcer diseases Eradication of H pylori infection could reduce the occurence or recurrence of these diseases However the eradication rate of clarithromycin-based triple therapy has been declining in recent years probably related to the increasing resistant rate to clarithromycin It was estimated that 15-20 of patients would fail from first line standard eradication therapy and need second line rescue therapy About 15-30 of patient would fail from second line therapy and need to be rescued with third line therapy In recent years the concept of sequential therapy has been advocated in the treatment of H pylori infection The regimen includes a PPI plus amoxicillin for five days followed by a PPI plus clarithromycin and tinidazole for another five days The eradication rate in the first line treatment of sequential therapy had been reported to be as high as 90 More importantly it has been demonstrated that the eradication rate among patients with clarithromycin-resistant strains could be as high as 89 However tinidazole is not available in many countries Whether metronidazole would be an effective alternative to tinidazole in the sequential therapy remains unknown Besides whether extending the duration of sequential therapy from 10-day to 14-day would result in higher eradication rate also deserves further investigation Furthermore data on the efficacy of rescue regimens for patients who failed from first line sequential therapy are also lacking The impact of clarithromycin metronidazole resistance and CYP2C19 polymorphism on the sequential therapy containing metronidazole rather than tinidazole also has not been reported
Aims Therefore we aim to assess
1 whether the substitution of metronidazole for tinidazole in the sequential therapy is also more effective than clarithromycin-based triple therapy
2 whether extending the duration of sequential therapy from 10-day to 14-day would achieve higher eradication rate
3 whether levofloxacin-based sequential therapy for 14-days is effective as second line rescue regimen for those who failed from first line sequential therapy
4 the impact of antibiotic resistance and CYP2C19 polymorphism on the eradication rate of sequential therapy
Aims Therefore we aim to assess
1 whether the substitution of metronidazole for tinidazole in the sequential therapy is also more effective than clarithromycin-based triple therapy
2 whether extending the duration of sequential therapy from 10-day to 14-day would achieve higher eradication rate
3 whether levofloxacin-based sequential therapy for 14-days is effective as second line rescue regimen for those who failed from first line sequential therapy
4 the impact of antibiotic resistance and CYP2C19 polymorphism on the eradication rate of sequential therapy
Detailed Description:
None
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 |
|---|---|---|---|
| 200909054M | Registry Identifier | NTUH | None |
| NTUH200909054M | REGISTRY | None | None |