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NCT Number: NCT02541786

Comparison of Dexlansoprazole-based Triple and Rabeprazole-based Triple Therapies for Helicobacter Pylori Infection

Dexlansoprazole MR is the R-enantiomer of lansoprazole that is delivered by a dual delayed release formulation. It is effective for symptom control of patients with gastroesophageal reflux disease. However, its efficacy in the treatment of H.pylori infection remains unclear. This study was conducted to investigate whether the efficacy of single-dose dexlansoprazole MR-based triple therapy was non-inferior to double-dose rabeprazole-based triple therapy in the treatment of H.pylori infection.

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Kaohsiung Medical University Hospital, Kaohsiung City, Taiwan

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About this study

Helicobacter pylori (H.pylori) infect more than 50% of humans globally. It is the major cause of chronic gastritis, gastric ulcer, duodenal ulcer, gastric adenocarcinoma and gastric mucosa-associated lymphoid tissue lymphoma (MALToma). H.pylori eradication has become the standard and most widely adopted therapy to cure peptic ulcer disease. This therapy is also strongly recommended in the treatment of H pylori-related MALToma. In regions with high incidence of gastric adenocarcinoma, eradication of H pylori is advocated as a preventative measure. Proton pump inhibitor (PPI) is one of the key medicines in anti-H pylori regimens. It possesses anti-H pylori activity, and, by reducing gastric acid secretion, it also increases bioavailability and activity of some antibiotics. This study was conducted to investigate whether the efficacy of single-dose dexlansoprazole MR-based triple therapy was non-inferior to double-dose rabeprazole-based triple therapy in the treatment of H pylori infection.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or non-pregnant female aged more than 20 years.
  • H. pylori-infected outpatients
  • Mental and legal ability to give a written informed consent.

Exclusion criteria

  • previous H pylori-eradication therapy,
  • ingestion of antibiotics or bismuth 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.

Treatment and study plan

dexlansoprazole based triple therapy

Drug

dexlansoprazole MR 60 mg once daily+clarithromycin 500 mg twice daily+ amoxicillin 1 g twice daily for 7 days

Other names: Dexilant-based triple therapy

rabeprazole-based triple therapy

Drug

rabeprazole 20 mg twice daily + clarithromycin 500 mg twice daily + amoxicillin 1 g twice daily for 7 days

Other names: Pariet-based triple therapy

Primary outcomes

  1. The rate of H.pylori eradication

    Time frame: 6 weeks after finishing study drugs

    Evaluate eradication outcome by 13C urea breath test

Secondary outcomes

  1. Drug Compliance

    Time frame: 6 weeks after finishing study drugs

    Good drug compliance measured by number of subjects taking >= 80% eradication medicines

Sponsors and collaborators

Lead sponsor

Kaohsiung Medical University

Other

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Sep 4, 2015
Registry last updated
Sep 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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