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

Helicobacter Pylori Infection Clinical Trial

Official title:

Five-day Concomitant Versus 10-day Sequential Therapy for Eradication of Helicobacter Pylori Infection: a Randomized Trial of Levofloxacin-based Regimens

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01544517
• Other study ID #: EudraCT 2010-02464415
• Status: Completed
• Phase: Phase 3
• First received: February 22, 2012
• Last updated: March 5, 2012
• Start date: January 2011
• Est. completion date: December 2011

Study information

• Verified date: February 2012
• Source: Second University of Naples
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: National Institute of Health
• Study type: Interventional

Clinical Trial Summary

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

Description:

The investigators studied 180 consecutive patients with H. pylori infection who were randomized to 5-day concomitant therapy (90 patients) and to 10-day sequential therapy (90 patients). 6 and 10 weeks after the end of therapy, patients were evaluated for their H. pylori status by 13C Urea Breath Test. Side effects and costs of either regimen were evaluated. In patients whose H pylori status at entry was assessed by endoscopy, culture was performed and antimicrobial resistance was determined

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: December 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Helicobacter Infections
• Helicobacter Pylori Infection
• Infection

Intervention

Drug:
• Eradication therapy (amoxicillin; esomeprazole; tinidazole; levofloxacin)
amoxicillin tablets 1 g; esomeprazole tablets 40mg; tinidazole tablets 500mg; levofloxacin tablets 500 mg

Locations

Country	Name	City	State
Italy	Dipartimento di Internistica Clinica e Sperimentale, SUN	Naples	Napoli

Sponsors (1)

Lead Sponsor	Collaborator
Second University of Naples

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Eradication Rate	The eradication rate obtained with the two treatments will be evaluated in the per-protocol and intention-to-treat analyses	1 year	No
Secondary	Adverse events	The incidence of adverse events during therapy will be assessed: bad taste, taste alteration, nausea, vomiting, diarrhoea, epigastric pain, glossitis, headache	1 year	No
Secondary	Costs of either regimen	The costs related to each treatment will be determined	1 year	No