Study of Levofloxacin-based Concomitant Therapy for H. Pylori Eradication in Diabetic Patients

Chung-Tai Wu

Status and phase: Completed; Phase 4

Conditions: Helicobacter Pylori Infection

Treatments: Drug: Pantoprazole; Drug: Clarithromycin; Drug: Levofloxacin; Drug: Amoxicillin; Drug: Metronidazole

Study type: Interventional

Funder types: Other

Identifiers

NCT02466919

MOHW103-TDU-B-211-113002 (Other Grant/Funding Number)

Details and patient eligibility

About

The study aims to evaluate H. pylori eradication rate in diabetic patients by using novel 10-day levofloxacin-based concomitant therapy compared with conventional 10-day sequential therapy.

Enrollment: 114 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diabetic patients with Helicobacter pylori infection

Exclusion criteria

• Pregnancy or physically poor performance status
• Patients with contraindication for upper endoscopy
• Severe coagulopathy for endoscopic biopsy
• Chronic kidney disease (eGFR < 50) or end stage renal disease
• Known allergy to interventional drugs
• Previous eradication failure

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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114 participants in 2 patient groups

Levofloxacin-based concomitant

Experimental group

Description:

Pantoprazole 40 mg BID day1\~day10 Amoxicillin 1000 mg BID day1\~day10 Metronidazole 500 mg BID day1\~day10 Levofloxacin 500 mg QD day1\~day10

Treatment:

Drug: Amoxicillin

Drug: Metronidazole

Drug: Levofloxacin

Drug: Pantoprazole

Sequential

Active Comparator group

Description:

Pantoprazole 40 mg BID day1\~day10 Amoxicillin 1000 mg BID day1\~day5 Metronidazole 500 mg BID day6\~day10 Clarithromycin 500 mg BID day6\~day10

Treatment:

Drug: Amoxicillin

Drug: Metronidazole

Drug: Clarithromycin

Drug: Pantoprazole