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Esomeprazole, Moxifloxacin and Amoxicilin for Rescue Therapy of Helicobacter Pylori Infection (ESAMOX)

Primary Purpose

Helicobacter Pylori Infection, Chronic Gastritis

Status
Unknown status
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
esomeprazole
moxifloxacin
amoxicillin
Sponsored by
Technische Universität Dresden
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Helicobacter Pylori Infection focused on measuring Helicobacter pylori, rescue therapy, eradication therapy, esomeprazole, moxifloxacin, resistance

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • male/female, age >/=18 years
  • Helicobacter pylori infection proven by histology and culture
  • indication for eradication therapy according to the Maastricht-III
  • at least one failed prior eradication attempt
  • pretherapeutic resistance testing (culture)
  • written informed consent

Exclusion Criteria:

  • in vitro resistance to moxifloxacin or amoxicillin
  • current complicated peptic ulcer disease
  • daily intake of NSAIDs
  • co-medication with drugs known to interact with the study medication
  • history of gastric surgery/vagotomy
  • medical treatment for depression, known suicide attempt
  • severe cardiological diseases such as bradyarrythmia, QT changes
  • malignant disease
  • gravidity, nursing
  • women with child bearing potential must perform contraceptive measures

Sites / Locations

  • Gastroenterologist, private praxisRecruiting
  • Med. Dept. I, Gastroenterology, University Hospital, Technical University of DresdenRecruiting
  • Gastroenterologist / private praxisRecruiting
  • Medical Department, University Homburg/SaarRecruiting
  • Medical Dept. I, University Hpspital KielRecruiting
  • Gastroenterologist / private praxisRecruiting
  • Technical University of Munich, Medical Dept. IIRecruiting
  • Gastroenterologist / private praxisRecruiting
  • Med. Department, Jung-Stilling KrankenhausRecruiting

Outcomes

Primary Outcome Measures

Efficacy of a combination of esomeprazole (E), moxifloxacin (M) and amoxicillin (A) for third line therapy of H. pylori infection.
Comparison of EMA 7 days versus EMA 14 days. Hypothesis: superiority of EMA 14 days 4 weeks after end of eradication therapy

Secondary Outcome Measures

Tolerability,safety, post treatment resistance, influence of host genetics (CYP status) and pathogenicity factors of H. pylori on treatment success.

Full Information

First Posted
April 3, 2007
Last Updated
April 3, 2007
Sponsor
Technische Universität Dresden
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1. Study Identification

Unique Protocol Identification Number
NCT00455806
Brief Title
Esomeprazole, Moxifloxacin and Amoxicilin for Rescue Therapy of Helicobacter Pylori Infection
Acronym
ESAMOX
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2007
Overall Recruitment Status
Unknown status
Study Start Date
January 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Technische Universität Dresden

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 patients.However, 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 countries,hence 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Helicobacter Pylori Infection, Chronic Gastritis
Keywords
Helicobacter pylori, rescue therapy, eradication therapy, esomeprazole, moxifloxacin, resistance

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
132 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
esomeprazole
Intervention Type
Drug
Intervention Name(s)
moxifloxacin
Intervention Type
Drug
Intervention Name(s)
amoxicillin
Primary Outcome Measure Information:
Title
Efficacy of a combination of esomeprazole (E), moxifloxacin (M) and amoxicillin (A) for third line therapy of H. pylori infection.
Title
Comparison of EMA 7 days versus EMA 14 days. Hypothesis: superiority of EMA 14 days 4 weeks after end of eradication therapy
Secondary Outcome Measure Information:
Title
Tolerability,safety, post treatment resistance, influence of host genetics (CYP status) and pathogenicity factors of H. pylori on treatment success.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: male/female, age >/=18 years Helicobacter pylori infection proven by histology and culture indication for eradication therapy according to the Maastricht-III at least one failed prior eradication attempt pretherapeutic resistance testing (culture) written informed consent Exclusion Criteria: in vitro resistance to moxifloxacin or amoxicillin current complicated peptic ulcer disease daily intake of NSAIDs co-medication with drugs known to interact with the study medication history of gastric surgery/vagotomy medical treatment for depression, known suicide attempt severe cardiological diseases such as bradyarrythmia, QT changes malignant disease gravidity, nursing women with child bearing potential must perform contraceptive measures
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stephan Miehlke, MD, PhD
Phone
+493514585645
Email
stephan.miehlk@uniklinikum-dresden.de
First Name & Middle Initial & Last Name or Official Title & Degree
Andrea Morgner, MD, PhD
Phone
+493514584460
Email
andrea.morgner-miehlke@uniklinikum-dresden.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephan Miehlke, MD, PhD
Organizational Affiliation
Medical Department I, Gastroenterology, Universityhospital, Technical University Dresden
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Norbert Lehn, MD, PhD
Organizational Affiliation
Institue for Medical Microbiology, University of Regensburg
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Enno Jacobs, MD, PhD
Organizational Affiliation
Institute for Medical Microbiology, Technical University of Dresden
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Manfred Stolte, MD, PhD
Organizational Affiliation
Institute for Pathology, Klinikum Bayreuth
Official's Role
Study Chair
Facility Information:
Facility Name
Gastroenterologist, private praxis
City
Cologne
ZIP/Postal Code
51063
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elke Bästlein, MD
First Name & Middle Initial & Last Name & Degree
Elke Bästlein, MD
Facility Name
Med. Dept. I, Gastroenterology, University Hospital, Technical University of Dresden
City
Dresden
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea Morgner-Miehlke, MD, PhD
First Name & Middle Initial & Last Name & Degree
Andrea Morgner-Miehlke, MD, PhD
Facility Name
Gastroenterologist / private praxis
City
Görlitz
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian Haferland, ME
First Name & Middle Initial & Last Name & Degree
Christian Haferland, MD
Facility Name
Medical Department, University Homburg/Saar
City
Homburg/Saar
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gerhard Treiber, MD, PhD
First Name & Middle Initial & Last Name & Degree
Gerhard Treiber, MD, PhD
Facility Name
Medical Dept. I, University Hpspital Kiel
City
Kiel
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stefan Hellmig, MD, PhD
First Name & Middle Initial & Last Name & Degree
Stefan Hellmig, MD, PhD
Facility Name
Gastroenterologist / private praxis
City
Munich
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wilfried Höchter, MD
First Name & Middle Initial & Last Name & Degree
Josef Weingart
First Name & Middle Initial & Last Name & Degree
Wilfried Höchter, MD
Facility Name
Technical University of Munich, Medical Dept. II
City
Munich
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexander Meining, MD, PhD
First Name & Middle Initial & Last Name & Degree
Alexander Meining, MD, PhD
Facility Name
Gastroenterologist / private praxis
City
Oldenburg
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Neumeyer, MD
First Name & Middle Initial & Last Name & Degree
Michael Neumeyer, MD
Facility Name
Med. Department, Jung-Stilling Krankenhaus
City
Siegen
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andreas Leodolter, MD
First Name & Middle Initial & Last Name & Degree
Joachim Labenz, MD, PhD
First Name & Middle Initial & Last Name & Degree
Andreas Leodolter, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
16916269
Citation
Morgner A, Labenz J, Miehlke S. Effective regimens for the treatment of Helicobacter pylori infection. Expert Opin Investig Drugs. 2006 Sep;15(9):995-1016. doi: 10.1517/13543784.15.9.995.
Results Reference
background
PubMed Identifier
16842467
Citation
Miehlke S, Hansky K, Schneider-Brachert W, Kirsch C, Morgner A, Madisch A, Kuhlisch E, Bastlein E, Jacobs E, Bayerdorffer E, Lehn N, Stolte M. Randomized trial of rifabutin-based triple therapy and high-dose dual therapy for rescue treatment of Helicobacter pylori resistant to both metronidazole and clarithromycin. Aliment Pharmacol Ther. 2006 Jul 15;24(2):395-403. doi: 10.1111/j.1365-2036.2006.02993.x.
Results Reference
background
PubMed Identifier
14535873
Citation
Miehlke S, Schneider-Brachert W, Bastlein E, Ebert S, Kirsch C, Haferland C, Buchner M, Neumeyer M, Vieth M, Stolte M, Lehn N, Bayerdorffer E. Esomeprazole-based one-week triple therapy with clarithromycin and metronidazole is effective in eradicating Helicobacter pylori in the absence of antimicrobial resistance. Aliment Pharmacol Ther. 2003 Oct 15;18(8):799-804. doi: 10.1046/j.1365-2036.2003.01764.x.
Results Reference
background
PubMed Identifier
11478749
Citation
Miehlke S, Bayerdorffer E, Graham DY. Treatment of Helicobacter pylori infection. Semin Gastrointest Dis. 2001 Jul;12(3):167-79.
Results Reference
background
PubMed Identifier
16423089
Citation
Cheon JH, Kim N, Lee DH, Kim JM, Kim JS, Jung HC, Song IS. Efficacy of moxifloxacin-based triple therapy as second-line treatment for Helicobacter pylori infection. Helicobacter. 2006 Feb;11(1):46-51. doi: 10.1111/j.0083-8703.2006.00371.x.
Results Reference
background
PubMed Identifier
15882245
Citation
Nista EC, Candelli M, Zocco MA, Cazzato IA, Cremonini F, Ojetti V, Santoro M, Finizio R, Pignataro G, Cammarota G, Gasbarrini G, Gasbarrini A. Moxifloxacin-based strategies for first-line treatment of Helicobacter pylori infection. Aliment Pharmacol Ther. 2005 May 15;21(10):1241-7. doi: 10.1111/j.1365-2036.2005.02412.x.
Results Reference
background
PubMed Identifier
11876707
Citation
Di Caro S, Ojetti V, Zocco MA, Cremonini F, Bartolozzi F, Candelli M, Lupascu A, Nista EC, Cammarota G, Gasbarrini A. Mono, dual and triple moxifloxacin-based therapies for Helicobacter pylori eradication. Aliment Pharmacol Ther. 2002 Mar;16(3):527-32. doi: 10.1046/j.1365-2036.2002.01165.x.
Results Reference
background
PubMed Identifier
12786627
Citation
Megraud F, Lamouliatte H. Review article: the treatment of refractory Helicobacter pylori infection. Aliment Pharmacol Ther. 2003 Jun 1;17(11):1333-43. doi: 10.1046/j.1365-2036.2003.01592.x.
Results Reference
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Esomeprazole, Moxifloxacin and Amoxicilin for Rescue Therapy of Helicobacter Pylori Infection

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