Amoxicillin/Metronidazole Based Quadruple Therapy for Helicobacter Pylori Eradication

NCT02175901 | Completed Phase 4

• 1 other identifier: rjkls2014006
• Study Type: interventional
• Target: 215
• Locations: 1 country
• Sites: 1

Brief Summary

No trial has examined the the efficacy of amoxicillin and metronidazole based quadruple therapy for Helicobacter pylori treatment. The study aims to compare the effectiveness and safety of 14-day amoxicillin-/metronidazole-based quadruple regiment and classical quadruple regiment for Helicobacter pylori eradication.

Conditions

Dyspepsia; Peptic Ulcer

Keywords

helicobacter pylori eradication; antibiotic

Outcome Measures

Primary Outcomes (1)

• Eradication rate of Helicobacter pylori

  Access eradication rate of H. pylori by intention to treat (ITT) and per-protocol (PP) analysis in each treatment group

  2 months

Secondary Outcomes (1)

• Frequency of side effects of each treatment

  2 months

Other Outcomes (1)

• Minimal inhibitory concentrations (MIC) of antibiotics against each helicobacter pylori clinical isolate

  2 months

Study Arms (2)

Amoxicillin/metronidazole

EXPERIMENTAL

Amoxicillin/metronidazole-based quadruple therapy for 14 days: Lansoprazole 30mg bid, Bismuth Potassium Citrate 220mg bid, amoxicillin 1000mg bid, Metronidazole 400mg qid

Drug: Lansoprazole; Drug: Bismuth Potassium Citrate; Drug: Amoxicillin; Drug: Metronidazole

Amoxicillin/clarithromycin

ACTIVE COMPARATOR

Amoxicillin/clarithromycin-based quadruple therapy for 14 days: Lansoprazole 30mg bid, Bismuth Potassium Citrate 220mg bid, Amoxicillin 1000mg bid, Clarithromycin 500mg bid

Drug: Lansoprazole; Drug: Bismuth Potassium Citrate; Drug: Amoxicillin; Drug: Clarithromycin

Interventions

Lansoprazole DRUG

antisecretory drug of each quadruple therapy

Also known as: proton pump inhibitor

Amoxicillin/clarithromycin; Amoxicillin/metronidazole

Bismuth Potassium Citrate DRUG

one component of each quadruple therapy

Also known as: Bismuth

Amoxicillin/clarithromycin; Amoxicillin/metronidazole

Amoxicillin DRUG

antibiotic of each quadruple therapy

Also known as: antibiotic

Amoxicillin/clarithromycin; Amoxicillin/metronidazole

Metronidazole DRUG

antibiotic of the amoxicillin/metronidazole-based quadruple therapy

Also known as: antibiotic

Amoxicillin/metronidazole

Clarithromycin DRUG

antibiotic of the amoxicillin/clarithromycin-based quadruple therapy

Also known as: antibiotic

Amoxicillin/clarithromycin

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants with non-investigated/functional dyspepsia or scarred peptic ulcer with indication of H pylori eradication treatment
• Ability and willingness to participate in the study and to sign and give informed consent
• confirmed H pylori infection by at least one of the following methods: C13-urea breath test, histology, rapid urease test or bacterial culture.

You may not qualify if:

• patients with peptic ulcer
• previous H. pylori eradication therapy
• Age below 18 years
• major systemic diseases
• previous gastric surgery
• pregnancy or breastfeeding
• allergy to any of the study drugs

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Shanghai Renji Hospital, Shanghai Jiao-Tong University School of Medicine

Shanghai, Shanghai Municipality, 200127, China

Location

Related Publications (4)

• Malfertheiner P, Megraud F, O'Morain CA, Atherton J, Axon AT, Bazzoli F, Gensini GF, Gisbert JP, Graham DY, Rokkas T, El-Omar EM, Kuipers EJ; European Helicobacter Study Group. Management of Helicobacter pylori infection--the Maastricht IV/ Florence Consensus Report. Gut. 2012 May;61(5):646-64. doi: 10.1136/gutjnl-2012-302084.

  PMID: 22491499 BACKGROUND

• Sun Q, Liang X, Zheng Q, Liu W, Xiao S, Gu W, Lu H. High efficacy of 14-day triple therapy-based, bismuth-containing quadruple therapy for initial Helicobacter pylori eradication. Helicobacter. 2010 Jun;15(3):233-8. doi: 10.1111/j.1523-5378.2010.00758.x.

  PMID: 20557366 BACKGROUND

• Lu H, Zhang W, Graham DY. Bismuth-containing quadruple therapy for Helicobacter pylori: lessons from China. Eur J Gastroenterol Hepatol. 2013 Oct;25(10):1134-40. doi: 10.1097/MEG.0b013e3283633b57.

  PMID: 23778309 BACKGROUND

• Zhang W, Chen Q, Liang X, Liu W, Xiao S, Graham DY, Lu H. Bismuth, lansoprazole, amoxicillin and metronidazole or clarithromycin as first-line Helicobacter pylori therapy. Gut. 2015 Nov;64(11):1715-20. doi: 10.1136/gutjnl-2015-309900. Epub 2015 Sep 2.

  PMID: 26338726 DERIVED

MeSH Terms

Conditions

Dyspepsia; Peptic Ulcer

Interventions

Lansoprazole; Proton Pump Inhibitors; Bismuth; Amoxicillin; Anti-Bacterial Agents; Metronidazole; Clarithromycin

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Duodenal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Elements, Radioactive; Elements; Inorganic Chemicals; Metals, Heavy; Radioisotopes; Isotopes; Metals; Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Anti-Infective Agents; Therapeutic Uses; Nitroimidazoles; Nitro Compounds; Imidazoles; Azoles; Erythromycin; Macrolides; Polyketides; Lactones

Study Officials

• Hong Lu, M.D.

  RenJi Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of GI Division

Study Record Dates

• First Submitted: June 24, 2014
• First Posted: June 26, 2014
• Study Start: July 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: February 3, 2015

Record last verified: 2015-02

Locations

CN (1)