Ignite Creation Date:
2024-05-05 @ 5:26 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00455806
Status:
UNKNOWN
Last Update Posted:
2007-04-04
First Post:
2007-04-03
Brief Title:
Esomeprazole Moxifloxacin and Amoxicilin for Rescue Therapy of Helicobacter Pylori Infection
Sponsor:
Technische Universität Dresden
Organization:
Technische Universität Dresden
Study Overview
Official Title:
Randomized Controlled Multicenter Phase III Study for the Efficacy and Tolerability of Triple Therapy With Esomeprazole Moxifloxacin and Amoxicillin for Rescue Therapy of Helicobacter Pylori Infection
Status:
UNKNOWN
Status Verified Date:
2007-03
Last Known Status:
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:
ESAMOX
Brief Summary:
Successful H pylori eradication therapy remains a challenge in medical practice Despite promising data for first-line second-line and rescue treatment options based on clinical trials as well as guidelines and expert recommendations success rates can often not be reproduced in general practice Rescue options for patients with failed initial or second-line therapy are definitely needed The new fluoroquinolone moxifloxacin may represent an effective and save treatment option in combination with a PPI and amoxicillin for rescue therapy of H- pylori positive patientsHowever optimal duration of therapy 7-day course vs 14-day course has to be determined
Detailed Description:
Successful H pylori eradication therapy remains a challenge in medical practice Currently a PPI - based triple therapy containing clarithromycin amoxicillin or nitroimidazole given for 7 days is the recommended first line treatment approach with an expected eradication success rate of approximately 80 As second-line treatment option in case of failure a RBC-based quadruple therapy is currently recommended curing another 80 of patients leaving a subset of patients with persistent H pylori infection Resistance to fluoroquinolones is low in most countrieshence these compounds are potential candidates for second-line and rescue treatment The new fluoroquinolone moxifloxacin launched by Bayer in 1999 for the treatment of respiratory tract infections has a broad antibacterial spectrum comparable to levofloxacin but fewer phototoxic and central nervous system excitatory effects The possible role of moxifloxacin in H pylori eradication is since under clinical investigation
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 |
|---|---|---|---|
| EudraCT Numberr 2006-004323-10 | None | None | None |