MedTrace Logo

Dexlansoprazole MR-Based Concomitant Quadruple Therapy

NCT03829150 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 202

Last updated 2019-05-14

No results posted yet for this study

Summary

Background:

Recommended proton pump inhibitor (PPI)-clarithromycin-amoxicillin or metronidazole treatment for 7 to14 days is the first choice treatment for H pylori infection. The eradication rate of the standard triple therapy has generally declined to unacceptable levels (i.e., 80% or less) recently because the increasing incidence of clarithromycin-resistant strains of H. pylori. Standard triple therapies should be abandoned in the areas with clarithromycin resistance ≥ 20%. The investigators have proven that 7-day Concomitant therapy can achieve a promising success rate of \>90 % in the presence of clarithromycin resistance. However, high dose PPI is needed with a dosage of twice daily but when a dual delayed release formulation PPI in capsules for oral administration (Dexlansoprazole MR), a once daily dose may be needed only. The capsules contain dexlansoprazole in a mixture of two types of enteric-coated granules with different pH-dependent dissolution profiles. It suppresses gastric acid secretion via inhibition of the proton pump in the gastric parietal cell, which blocks the final step of acid production. Thus, it improves acid suppression and offer benefits over conventional single release PPI formulations. by prolonging optimal plasma concentration and create a favorable condition H. pylori eradication

Aim:

The efficacy of Dexlansoprazole MR-based concomitant quadruple therapy

Conditions

  • Helicobacter Pylori Infection

Interventions

DRUG

Dexlan

Dexlansoprazole MR 60 mg qd for 7 days

DRUG

Amoxicillin

Amoxicillin (Amolin) 1 g bid. for 7 days

DRUG

Clarithromycin 500mg

clarithromycin (Klaricid) 500 mg bid for 7 days

DRUG

Metronidazole

Metronidazole (Flagyl) 500 mg bid daily for 7 days

Sponsors & Collaborators

  • Chang Gung Memorial Hospital

    lead OTHER

Principal Investigators

  • Seng-Kee Chuah, MD · Kaohsiung Chang Gung Memorial Hospital,Taiwan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-01
Primary Completion
2019-04-20
Completion
2019-04-20

Countries

  • Taiwan

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03829150 on ClinicalTrials.gov