Efficacy of High-dose Dual Therapy vs Bismuth-containing Quadruple Therapy for Rescue Treatment of Hp Infection

NCT02490839 | Completed Phase 4 DMC

• 1 other identifier: 201504037MINB
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 1

Brief Summary

Up to now, there is few randomized, large scale study prospectively and simultaneously comparing the efficacy, adverse effects and patient adherence of high-dose dual therapy (HDDT) and bismuth-containing quadruple therapy (BQT) as rescue regimens for H. pylori eradication. The aims of this study are:

1. 1.to compare the efficacy of HDDT, and BQT as rescue regimen in H. pylori eradication;
2. 2.to compare the patient adherence and adverse effects of these treatment regimens;
3. 3.to investigate factors that may influence H. pylori eradication by these treatment regimens.

Conditions

Helicobacter Pylori Infection

Keywords

Helicobacter pylori; high dose dual therapy; bismuth-containing quadruple therapy; antibiotic resistance

Outcome Measures

Primary Outcomes (1)

• The eradication rates as a measure of the efficacy of HDDT, and BQT

  The eradication rates (efficacy) will be evaluated by intention-to-treat (ITT) and per-protocol (PP) analysis.

  3.5 years

Secondary Outcomes (2)

• Number of participants with adverse effects as a measure of safety

  3.5 years

• Amount of unused medication post treatment as a measure of patient adherence.

  3.5 years

Study Arms (2)

High-dose dual therapy

EXPERIMENTAL

group A-high-dose dual therapy ( rabeprazole 20 mg, tablet, qid + amoxicillin 750 mg, capsule, qid for 14 days)

Drug: High-dose dual therapy (rabeprazole, amoxicillin)

Bismuth-containing quadruple therapy

ACTIVE COMPARATOR

group B-bismuth-containing quadruple therapy (rabeprazole 20 mg, tablet, bid + tripotassium dicitrate bismuthate 300 mg, tablet, qid + metronidazole 250 mg, tablet, qid + tetracycline 500 mg qid, capsule, for 10 days)

Drug: Bismuth-containing quadruple therapy (rabeprazole, tripotassium dicitrate bismuthate, metronidazole, tetracycline)

Interventions

High-dose dual therapy (rabeprazole, amoxicillin) DRUG

High-dose dual therapy ( rabeprazole 20 mg qid + amoxicillin 750 mg qid for 14 days)

Also known as: Proton pump inhibitor, Rabeprazole, Pariet®, Antibiotics, Amoxicillin ,Amoxicillin®

High-dose dual therapy

Bismuth-containing quadruple therapy (rabeprazole, tripotassium dicitrate bismuthate, metronidazole, tetracycline) DRUG

Bismuth-containing quadruple therapy (rabeprazole 20 mg bid + tripotassium dicitrate bismuthate 300 mg qid + metronidazole 250 mg qid + tetracycline 500 mg qid for 10 days)

Also known as: Proton pump inhibitor, Rabeprazole, Pariet®, Antibiotics, Metronidazole, Flagyl®, Antibiotics, Tetracycline, Tetracycline®, Colloidal Bismuth, Tripotassium dicitrate bismuthate, KCB®

Bismuth-containing quadruple therapy

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Participants having H. pylori related chronic gastritis with/without peptic ulcers who are aged greater than 20 years old and are willing to received eradication therapy.

You may not qualify if:

• pregnant or nursing woman
• serious concomitant illness and malignant tumor of any kind
• history of hypersensitivity to test drugs
• serious bleeding during the course of the ulcer
• previous gastric surgery
• receiving bismuth salts, PPIs, or antibiotics in the previous month.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 10002, Taiwan

Location

MeSH Terms

Interventions

Rabeprazole; Amoxicillin; Proton Pump Inhibitors; Anti-Bacterial Agents; Metronidazole; Tetracycline

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; Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Anti-Infective Agents; Therapeutic Uses; Nitroimidazoles; Nitro Compounds; Imidazoles; Azoles; Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Study Officials

• Jyh-Chin Yang, M.D.Ph.D.

  National Taiwan University 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: SPONSOR

Study Record Dates

• First Submitted: July 2, 2015
• First Posted: July 7, 2015
• Study Start: July 1, 2015
• Primary Completion: November 1, 2018
• Study Completion: January 1, 2019
• Last Updated: April 29, 2020

Record last verified: 2020-04

Locations

TW (1)