Esomeprazole, Moxifloxacin and Amoxicilin for Rescue Therapy of Helicobacter Pylori Infection - Full Text View

Sponsor:	Dresden University of Technology
Information provided by:	Dresden University of Technology
ClinicalTrials.gov Identifier:	NCT00455806

Purpose

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

Condition	Intervention	Phase
Helicobacter Pylori Infection Chronic Gastritis	Drug: esomeprazole Drug: moxifloxacin Drug: amoxicillin	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

Drug Information available for: Amoxicillin Amoxicillin sodium Amoxicillin trihydrate Omeprazole Omeprazole magnesium Moxifloxacin Esomeprazole Sodium Esomeprazole magnesium Moxifloxacin hydrochloride

U.S. FDA Resources

Further study details as provided by Dresden University of Technology:

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.

Estimated Enrollment:	132
Study Start Date:	January 2007
Estimated Study Completion Date:	February 2008

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00455806

Contacts

Contact: Stephan Miehlke, MD, PhD	+493514585645	stephan.miehlk@uniklinikum-dresden.de
Contact: Andrea Morgner, MD, PhD	+493514584460	andrea.morgner-miehlke@uniklinikum-dresden.de

Locations

Germany
Gastroenterologist, private praxis	Recruiting
Cologne, Germany, 51063
Contact: Elke Bästlein, MD
Principal Investigator: Elke Bästlein, MD
Med. Dept. I, Gastroenterology, University Hospital, Technical University of Dresden	Recruiting
Dresden, Germany
Contact: Andrea Morgner-Miehlke, MD, PhD
Principal Investigator: Andrea Morgner-Miehlke, MD, PhD
Gastroenterologist / private praxis	Recruiting
Görlitz, Germany
Contact: Christian Haferland, ME
Principal Investigator: Christian Haferland, MD
Medical Department, University Homburg/Saar	Recruiting
Homburg/Saar, Germany
Contact: Gerhard Treiber, MD, PhD
Principal Investigator: Gerhard Treiber, MD, PhD
Medical Dept. I, University Hpspital Kiel	Recruiting
Kiel, Germany
Contact: Stefan Hellmig, MD, PhD
Principal Investigator: Stefan Hellmig, MD, PhD
Technical University of Munich, Medical Dept. II	Recruiting
Munich, Germany
Contact: Alexander Meining, MD, PhD
Principal Investigator: Alexander Meining, MD, PhD
Gastroenterologist / private praxis	Recruiting
Munich, Germany
Contact: Wilfried Höchter, MD
Contact: Josef Weingart
Principal Investigator: Wilfried Höchter, MD
Gastroenterologist / private praxis	Recruiting
Oldenburg, Germany
Contact: Michael Neumeyer, MD
Principal Investigator: Michael Neumeyer, MD
Med. Department, Jung-Stilling Krankenhaus	Recruiting
Siegen, Germany
Contact: Andreas Leodolter, MD
Contact: Joachim Labenz, MD, PhD
Principal Investigator: Andreas Leodolter, MD

Sponsors and Collaborators

Dresden University of Technology

Investigators

Principal Investigator:	Stephan Miehlke, MD, PhD	Medical Department I, Gastroenterology, Universityhospital, Technical University Dresden
Study Chair:	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

More Information

Publications:

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. Review.

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.

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.

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

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.

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.

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.

Megraud F, Lamouliatte H. Review article: the treatment of refractory Helicobacter pylori infection. Aliment Pharmacol Ther. 2003 Jun 1;17(11):1333-43. Review.

ClinicalTrials.gov Identifier:	NCT00455806 History of Changes
Other Study ID Numbers:	ESAMOX_01_2007, EudraCT Numberr 2006-004323-10
Study First Received:	April 3, 2007
Last Updated:	April 3, 2007
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Dresden University of Technology:

Helicobacter pylori
rescue therapy
eradication therapy

esomeprazole
moxifloxacin
resistance

Additional relevant MeSH terms:

Gastritis
Gastritis, Atrophic
Helicobacter Infections
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Gram-Negative Bacterial Infections
Bacterial Infections
Amoxicillin
Moxifloxacin
Omeprazole
Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents

Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Ulcer Agents
Gastrointestinal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 09, 2012