Dexlansoprazole MR-Based Concomitant Quadruple Therapy

NCT03829150 | Completed DMC

• 1 other identifier: CMRPG8F1421
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

non-bismuth containing quadruple therapy

Outcome Measures

Primary Outcomes (1)

• The rates of H.pylori eradication

  The primary outcome variables were the rates of eradication. Chi-square test with or without Yates correction for continuity and Fisher's exact test were used when appropriate to compare the major outcomes between groups. A P value less than 0.05 was considered statistically significant.

  8 weeks

Study Arms (2)

Dexlansoprazole MR group

EXPERIMENTAL

Dexlansoprazole MR 60 mg qd.,clarithromycin 500 mg bid., amoxicillin 1 g bid. and metronidazole 500 mg bid. for 7 days

Drug: Dexlan; Drug: Amoxicillin; Drug: Clarithromycin 500mg; Drug: Metronidazole

lansoprazole group

EXPERIMENTAL

Lansoprazole 30 mg bid., clarithromycin 500 mg bid., amoxicillin 1 g bid. and metronidazole 500 mg bid. for 7 days

Drug: Dexlan; Drug: Amoxicillin; Drug: Clarithromycin 500mg; Drug: Metronidazole

Interventions

Dexlan DRUG

Dexlansoprazole MR 60 mg qd for 7 days

Also known as: Dexlansoprazole MR

Dexlansoprazole MR group; lansoprazole group

Amoxicillin DRUG

Amoxicillin (Amolin) 1 g bid. for 7 days

Also known as: Amolin

Dexlansoprazole MR group; lansoprazole group

Clarithromycin 500mg DRUG

clarithromycin (Klaricid) 500 mg bid for 7 days

Also known as: Klaricid

Dexlansoprazole MR group; lansoprazole group

Metronidazole DRUG

Metronidazole (Flagyl) 500 mg bid daily for 7 days

Also known as: Flagyl

Dexlansoprazole MR group; lansoprazole group

Eligibility Criteria

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

You may qualify if:

• H. pylori-infected outpatients with endoscopically proven peptic ulcer diseases or gastritis.

You may not qualify if:

• Previous H. pylori-eradication therapy
• ingestion of antibiotics, bismuth, or PPIs within the prior 4 weeks
• patients with allergic history to the medications used
• patients with previous gastric surgery
• the coexistence of serious concomitant illness (for example, decompensated liver cirrhosis, uremia)
• pregnant women.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Kaohsiung Chang Gung Memorial Hospital,Taiwan

Kaohsiung City, 833, Taiwan

Location

Related Publications (1)

• Tai WC, Liang CM, Bi KW, Kuo CM, Lu LS, Wu CK, Yang SC, Kuo YH, Lee CH, Huang CF, Hsu CN, Hsu PI, Wu DC, Hu TH, Wu KL, Chuah SK. A comparison between dexlansoprazole modified release-based and lansoprazole-based nonbismuth quadruple (concomitant) therapy for first-line Helicobacter pylori eradication: a prospective randomized trial. Infect Drug Resist. 2019 Sep 16;12:2923-2931. doi: 10.2147/IDR.S213998. eCollection 2019.

  PMID: 31571945 DERIVED

MeSH Terms

Interventions

Amoxicillin; Clarithromycin; Metronidazole

Intervention Hierarchy (Ancestors)

Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Erythromycin; Macrolides; Polyketides; Lactones; Nitroimidazoles; Nitro Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring

Study Officials

• Seng-Kee Chuah, MD

  Kaohsiung Chang Gung Memorial Hospital,Taiwan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 28, 2019
• First Posted: February 4, 2019
• Study Start: March 1, 2017
• Primary Completion: April 20, 2019
• Study Completion: April 20, 2019
• Last Updated: May 14, 2019

Record last verified: 2019-05

Locations

TW (1)