5 Day Concomitant Versus 10 Day Sequential Therapy for Eradication of H. Pylori Infection

NCT01544517 | Completed Phase 3 DMC

• 1 other identifier: EudraCT 2010-02464415
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

A five day quadruple concomitant therapy is as effective and safe as a 10 day sequential therapy for eradication of H. pylori infection.

Conditions

Helicobacter Pylori Infection

Keywords

Helicobacter pylori; Concomitant therapy; Sequential therapy; levofloxacin

Outcome Measures

Primary Outcomes (1)

• Eradication Rate

  The eradication rate obtained with the two treatments will be evaluated in the per-protocol and intention-to-treat analyses

  1 year

Secondary Outcomes (2)

• Adverse events

  1 year

• Costs of either regimen

  1 year

Study Arms (2)

5d-QCT

EXPERIMENTAL

5-day eradication regimen consisting in the concomitant administration of esomeprazole 40mg bid + amoxicillin 1g bid + levofloxacin 500mg bid + tinidazole 500mg bid

Drug: Eradication therapy (amoxicillin; esomeprazole; tinidazole; levofloxacin)

10-day sequential regimen

ACTIVE COMPARATOR

5 days of esomeprazole 40mg bid + amoxicillin 40mg bid followed by 5 more days of esomeprazole 40mg bid + levofloxacin 500mg bid + tinidazole 500 mg bid

Drug: Eradication therapy (amoxicillin; esomeprazole; tinidazole; levofloxacin)

Interventions

Eradication therapy (amoxicillin; esomeprazole; tinidazole; levofloxacin) DRUG

amoxicillin tablets 1 g; esomeprazole tablets 40mg; tinidazole tablets 500mg; levofloxacin tablets 500 mg

Also known as: proton pump inhibitors

10-day sequential regimen; 5d-QCT

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• H. pylori-infected patients who were at least 18 years of age and who had never received H. pylori eradication treatment were included in the study.

You may not qualify if:

• previous treatment for H. pylori infection,
• use of inhibitors of acid secretion and/or antibiotics during the 6 weeks before the study,
• gastrointestinal malignancy,
• previous gastro-oesophageal surgery,
• severe concomitant cardiovascular,
• respiratory or endocrine diseases,
• clinically significant renal or hepatic disease,
• hematologic disorders,
• any other clinically significant medical condition that could increase risk,
• history of allergy to any of the drug used in the study,
• pregnancy or lactation,
• alcohol abuse,
• drug addiction,
• severe neurologic or psychiatric disorders, and
• long-term use of corticosteroids or anti-inflammatory drugs.

Sponsors & Collaborators

• University of Campania Luigi Vanvitelli: lead

Study Sites (1)

Dipartimento di Internistica Clinica e Sperimentale, SUN

Naples, Napoli, 80131, Italy

Location

MeSH Terms

Interventions

Amoxicillin; Esomeprazole; Tinidazole; Levofloxacin; Proton Pump Inhibitors

Intervention Hierarchy (Ancestors)

Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Pyridines; Heterocyclic Compounds, 1-Ring; Benzimidazoles; Nitroimidazoles; Nitro Compounds; Imidazoles; Azoles; Ofloxacin; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Marco Romano, MD

  Second University of Naples Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Gastroenterology

Study Record Dates

• First Submitted: February 22, 2012
• First Posted: March 6, 2012
• Study Start: January 1, 2011
• Primary Completion: May 1, 2011
• Study Completion: December 1, 2011
• Last Updated: March 6, 2012

Record last verified: 2012-02

Locations

IT (1)