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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2007 by Technische Universität Dresden.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Technische Universität Dresden
ClinicalTrials.gov Identifier:
NCT00455806
First received: April 3, 2007
Last updated: NA
Last verified: March 2007
History: No changes posted
  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 3

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:


Further study details as provided by Technische Universität Dresden:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Technische Universität Dresden
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:

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 Technische Universität Dresden:
Helicobacter pylori
rescue therapy
eradication therapy
esomeprazole
moxifloxacin
resistance

Additional relevant MeSH terms:
Helicobacter Infections
Gastritis
Gastritis, Atrophic
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Gram-Negative Bacterial Infections
Bacterial Infections
Amoxicillin
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Omeprazole
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 20, 2014