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

NCT ID: NCT00455806

Last Updated: 2007-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2008-02-29

Brief Summary

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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

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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

Conditions

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Helicobacter Pylori Infection Chronic Gastritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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esomeprazole

Intervention Type DRUG

moxifloxacin

Intervention Type DRUG

amoxicillin

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Technische Universität Dresden

OTHER

Sponsor Role lead

Principal Investigators

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Stephan Miehlke, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Medical Department I, Gastroenterology, Universityhospital, Technical University Dresden

Norbert Lehn, MD, PhD

Role: STUDY_CHAIR

Institue for Medical Microbiology, University of Regensburg

Enno Jacobs, MD, PhD

Role: STUDY_CHAIR

Institute for Medical Microbiology, Technical University of Dresden

Manfred Stolte, MD, PhD

Role: STUDY_CHAIR

Institute for Pathology, Klinikum Bayreuth

Locations

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Gastroenterologist, private praxis

Cologne, , Germany

Site Status RECRUITING

Med. Dept. I, Gastroenterology, University Hospital, Technical University of Dresden

Dresden, , Germany

Site Status RECRUITING

Gastroenterologist / private praxis

Görlitz, , Germany

Site Status RECRUITING

Medical Department, University Homburg/Saar

Homburg/Saar, , Germany

Site Status RECRUITING

Medical Dept. I, University Hpspital Kiel

Kiel, , Germany

Site Status RECRUITING

Gastroenterologist / private praxis

Munich, , Germany

Site Status RECRUITING

Technical University of Munich, Medical Dept. II

Munich, , Germany

Site Status RECRUITING

Gastroenterologist / private praxis

Oldenburg, , Germany

Site Status RECRUITING

Med. Department, Jung-Stilling Krankenhaus

Siegen, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Stephan Miehlke, MD, PhD

Role: CONTACT

[email protected]
+493514585645

Andrea Morgner, MD, PhD

Role: CONTACT

[email protected]
+493514584460

Facility Contacts

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Elke Bästlein, MD

Role: primary

Andrea Morgner-Miehlke, MD, PhD

Role: primary

Christian Haferland, ME

Role: primary

Gerhard Treiber, MD, PhD

Role: primary

Stefan Hellmig, MD, PhD

Role: primary

Wilfried Höchter, MD

Role: primary

Josef Weingart

Role: backup

Alexander Meining, MD, PhD

Role: primary

Michael Neumeyer, MD

Role: primary

Andreas Leodolter, MD

Role: primary

Joachim Labenz, MD, PhD

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 16916269 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16842467 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14535873 (View on PubMed)

Miehlke S, Bayerdorffer E, Graham DY. Treatment of Helicobacter pylori infection. Semin Gastrointest Dis. 2001 Jul;12(3):167-79.

Reference Type BACKGROUND
PMID: 11478749 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16423089 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15882245 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11876707 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12786627 (View on PubMed)

Other Identifiers

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EudraCT Numberr 2006-004323-10

Identifier Type: -

Identifier Source: secondary_id

ESAMOX_01_2007

Identifier Type: -

Identifier Source: org_study_id