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

NCT00455806 | Unknown Phase 3 DMC

• 2 other identifiers: ESAMOX_01_2007EudraCT Numberr 2006-004323-10
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 9

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

Conditions

Helicobacter Pylori Infection; Chronic Gastritis

Keywords

Helicobacter pylori; rescue therapy; eradication therapy; esomeprazole; moxifloxacin; resistance

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

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

Interventions

esomeprazole DRUG

moxifloxacin DRUG

amoxicillin DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Technische Universität Dresden: lead

Study Sites (9)

Gastroenterologist, private praxis

Cologne, 51063, Germany

RECRUITING

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

Dresden, Germany

RECRUITING

Gastroenterologist / private praxis

Görlitz, Germany

RECRUITING

Medical Department, University Homburg/Saar

Homburg/Saar, Germany

RECRUITING

Medical Dept. I, University Hpspital Kiel

Kiel, Germany

RECRUITING

Gastroenterologist / private praxis

Munich, Germany

RECRUITING

Technical University of Munich, Medical Dept. II

Munich, Germany

RECRUITING

Gastroenterologist / private praxis

Oldenburg, Germany

RECRUITING

Med. Department, Jung-Stilling Krankenhaus

Siegen, Germany

RECRUITING

Related Publications (8)

• 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.

  PMID: 16916269 BACKGROUND

• 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.

  PMID: 16842467 BACKGROUND

• 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.

  PMID: 14535873 BACKGROUND

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

  PMID: 11478749 BACKGROUND

• 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.

  PMID: 16423089 BACKGROUND

• 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.

  PMID: 15882245 BACKGROUND

• 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.

  PMID: 11876707 BACKGROUND

• 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.

  PMID: 12786627 BACKGROUND

MeSH Terms

Interventions

Esomeprazole; Moxifloxacin; Amoxicillin

Intervention Hierarchy (Ancestors)

Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides

Study Officials

• Stephan Miehlke, MD, PhD

  Medical Department I, Gastroenterology, Universityhospital, Technical University Dresden

  PRINCIPAL INVESTIGATOR

• Norbert Lehn, MD, PhD

  Institue for Medical Microbiology, University of Regensburg

  STUDY CHAIR

• Enno Jacobs, MD, PhD

  Institute for Medical Microbiology, Technical University of Dresden

  STUDY CHAIR

• Manfred Stolte, MD, PhD

  Institute for Pathology, Klinikum Bayreuth

  STUDY CHAIR

Central Study Contacts

Stephan Miehlke, MD, PhD

CONTACT

+493514585645; stephan.miehlk@uniklinikum-dresden.de

Andrea Morgner, MD, PhD

CONTACT

+493514584460; andrea.morgner-miehlke@uniklinikum-dresden.de

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 3, 2007
• First Posted: April 4, 2007
• Study Start: January 1, 2007
• Study Completion: February 1, 2008
• Last Updated: April 4, 2007

Record last verified: 2007-03

Locations

DE (9)