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Helicobacter Pylori InfectionPhase 3ESAMOXNCT00455806

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

A Phase 3 study testing esomeprazole, moxifloxacin and amoxicillin in people with Helicobacter Pylori Infection and Chronic Gastritis, run by Technische Universität Dresden at 9 sites in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
esomeprazole, moxifloxacin and amoxicillin
How many people
132 participants
Where
9 sitesGermany
Study dates
Jan 2007to Feb 2008
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • severe cardiological diseases such as bradyarrythmia, QT changes
  • malignant disease
  • gravidity, nursing
  • women with child bearing potential must perform contraceptive measures

Trial locations and contacts

9 sites in 1 country.

Stephan Miehlke, MD, PhD contact

+493514585645

stephan.miehlk@uniklinikum-dresden.de

Andrea Morgner, MD, PhD contact

+493514584460

andrea.morgner-miehlke@uniklinikum-dresden.de

9 sites in 1 country

Germany9 sites, 9 recruiting

  • Gastroenterologist, private praxis

    Cologne, 51063

    Elke Bästlein, MD

    Elke Bästlein, MD

    Recruiting

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

    Dresden

    Andrea Morgner-Miehlke, MD, PhD

    Andrea Morgner-Miehlke, MD, PhD

    Recruiting

  • Gastroenterologist / private praxis

    Görlitz

    Christian Haferland, ME

    Christian Haferland, MD

    Recruiting

  • Medical Department, University Homburg/Saar

    Homburg/Saar

    Gerhard Treiber, MD, PhD

    Gerhard Treiber, MD, PhD

    Recruiting

  • Medical Dept. I, University Hpspital Kiel

    Kiel

    Stefan Hellmig, MD, PhD

    Stefan Hellmig, MD, PhD

    Recruiting

  • Gastroenterologist / private praxis

    Munich

    Wilfried Höchter, MD

    Josef Weingart

    Recruiting

  • Technical University of Munich, Medical Dept. II

    Munich

    Alexander Meining, MD, PhD

    Alexander Meining, MD, PhD

    Recruiting

  • Gastroenterologist / private praxis

    Oldenburg

    Michael Neumeyer, MD

    Michael Neumeyer, MD

    Recruiting

  • Med. Department, Jung-Stilling Krankenhaus

    Siegen

    Andreas Leodolter, MD

    Joachim Labenz, MD, PhD

    Recruiting

Other trials in Germany

About this study

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

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

Read the 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

Keywords
Helicobacter pylori, rescue therapy, eradication therapy, esomeprazole, moxifloxacin, resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Efficacy of a combination of esomeprazole (E), moxifloxacin (M) and amoxicillin (A) for third line therapy of H. pylori infection.

  2. 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)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Apr 2007 (estimated)
  2. Study startJan 2007
  3. Study completionFeb 2008 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
132 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00455806
Sponsor's protocol ID
ESAMOX_01_2007
Other IDs
EudraCT Numberr 2006-004323-10
Acronym
ESAMOX
Status last verified
Mar 2007
First submitted
3 Apr 2007
Last updated
4 Apr 2007
Results posted
No
Data monitoring committee
Yes

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. doi: 10.1517/13543784.15.9.995.

    PubMed 16916269

  • 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.

    PubMed 16842467

  • 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.

    PubMed 14535873

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

    PubMed 11478749

  • 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.

    PubMed 16423089

  • 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.

    PubMed 15882245

  • 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.

    PubMed 11876707

  • 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.

    PubMed 12786627

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing esomeprazole, moxifloxacin and amoxicillin in people with Helicobacter Pylori Infection and Chronic Gastritis, run by Technische Universität Dresden at 9 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 4 Apr 2007. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Stephan Miehlke, MD, PhD (+493514585645, stephan.miehlk@uniklinikum-dresden.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy of a combination of esomeprazole (E), moxifloxacin (M) and amoxicillin (A) for third line therapy of H. pylori infection.. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00455806, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2007.

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