High Dose of Dual Therapy Plus Bismuth for Helicobacter Pylori Treatment

NCT03405584 | Completed Phase 4 DMC

• 1 other identifier: rjkls2017196
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

Dual therapy for Helicobacter Pylori including a proton pump inhibitor (PPI) and amoxicillin. Amoxicillin has low resistance rate as well as low percentage of side effects. No trial has examined the the efficacy of high dose of dual therapy plus bismuth for H. pylori treatment.This study is designed to evaluate the efficacy and safety of the addition of bismuth to high dose of dual therapy for H. pylori eradication.

Conditions

Helicobacter Pylori Infection

Keywords

Helicobacter pylori; Therapy

Outcome Measures

Primary Outcomes (1)

• Helicobacter pylori eradication rate

  Six weeks after completion of therapy, H. pylori eradication was assessed by ¹³C-urea breath test. Eradication was defined as negative result from urea breath test (\<4‰) (4‰ as the cutoff value).

  Six weeks after completion of therapy

Secondary Outcomes (2)

• Rate of adverse effects

  Within 7 days after completion of therapy.

• Compliance rate

  Within 7 days after completion of therapy.

Study Arms (2)

Bismuth Plus Dual Therapy

EXPERIMENTAL

Esomeprazole 40mg bid, Amoxicillin 1.0g tid and Bismuth Potassium Citrate 600mg bid for 14 days.

Drug: Esomeprazole; Drug: Amoxicillin; Drug: Bismuth Potassium Citrate

Dual Therapy

ACTIVE COMPARATOR

Esomeprazole 40mg bid and Amoxicillin 1.0g tid for 14 days.

Drug: Esomeprazole; Drug: Amoxicillin

Interventions

Esomeprazole DRUG

Proton pump inhibitor

Bismuth Plus Dual Therapy; Dual Therapy

Amoxicillin DRUG

Antibiotic for H. pylori eradication

Bismuth Plus Dual Therapy; Dual Therapy

Bismuth Potassium Citrate DRUG

Gastric mucosal protective drug with anti-H. pylori effect

Bismuth Plus Dual Therapy

Eligibility Criteria

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

You may qualify if:

• Participants with non-ulcer functional dyspepsia or peptic ulcer disease
• Ability and willingness to participate in the study and to sign and give informed consent
• Confirmed H. pylori infection

You may not qualify if:

• Less than 18 years old
• With previous gastric surgery
• Major systemic diseases
• Pregnancy or lactation

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, 200127, China

Location

MeSH Terms

Interventions

Esomeprazole; Amoxicillin

Intervention Hierarchy (Ancestors)

Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides

Study Officials

• Hong Lu, M.D

  Renji Hospital, School of Medicine, Shanghai Jiao Tong University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor of Division of Gastroenterology and Hepatology of Renji Hospital,Professor of Medicine

Study Record Dates

• First Submitted: January 13, 2018
• First Posted: January 23, 2018
• Study Start: January 3, 2018
• Primary Completion: November 2, 2018
• Study Completion: November 2, 2018
• Last Updated: November 5, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)