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Completed

NCT Number: NCT03087162

Once Daily Dose Dexlansoprazole Quadruple Therapy for Helicobacter Pylori

New drug regimen for Helicobacter pylori eradication, the investigators compare once daily dose dexlansoprazole levofloxacin based quadruple therapy and twice daily dose dexlansoprazole levofloxacin quadruple therapy for helicobacter pylori eradication.

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Key information

Conditions

H Pylori Eradication

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Parin siriwat

Bangkok, 10400, Thailand

About this study

Once daily dose dexlansoprazole should be non inferior to twice daily dose in the eradication of Helicobacter pylori infection.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 18-75 year-patient
  • Diagnosed as positive Helicobacter Pylori testing by any of the following methods:
  • Rapid urease test or Histology
  • Inform consent

Exclusion criteria

  • Previous history of Helicobacter pylori eradication
  • Contraindications or allergic reactions to the study drugs
  • Previous gastric surgery or advanced gastric cancer or other malignancy or other severe concurrent diseases
  • Decompensated Liver cirrhosis or chronic kidney disease (GFR< 30)
  • Mental disorders or alcohol or drug addiction
  • Pregnancy or lactation

Treatment and study plan

Dexlansoprazole 60 mg once daily

Drug

Once daily dose dexlansoprazole(Dexlansoprazole(60) OD) in experimental arm and Twice daily dose dexlansoprazole(Dexlansoprazole(60) 1 BID) in active arm

Other names: dexilant

Primary outcomes

  1. Eradication rate (percentage)

    Time frame: Jan17-Nov17, Total 11 months

    Compare eradication rate of helicobacter pylori between 2 groups

Secondary outcomes

  1. To compare drug compliance

    Time frame: jan17-Nov17, Total 11 months

    The investigators measure drug compliance between 2 groups, The investigators consider more than 85% of taking medications is a good compliance.

  2. To compare drug adverse event

    Time frame: jan17-Nov17, Total 11 months

    The investigators measure adverse events as

    • Nausea/Vomiting
    • Abdominal pain/Abdominal discomfort/Abdominal Bloating
    • Diarrhea/ Constipation
    • Taste distortions
    • Headache/Dizziness
    • Rash/Itching/Drug allergy, Any symptoms occur new onset during taking medications, The investigators consider as an adverse events of an experiment.

Sponsors and collaborators

Lead sponsor

Ramathibodi Hospital

Other

Registry information

Official study title

Once Daily Dose Dexlansoprazole Levofloxacin Based Quadruple Therapy for Helicobacter Pylori Eradication: A Randomized Controlled Study

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Mar 22, 2017
Registry last updated
Apr 3, 2018

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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