Once Daily Dose Dexlansoprazole Quadruple Therapy for Helicobacter Pylori

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

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.

Study Overview

• Status: Completed
• Conditions: H Pylori Eradication
• Intervention / Treatment: Drug: Dexlansoprazole 60 mg once daily

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 180
• Phase: Phase 4

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand, 10400
    • Parin siriwat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age 18-75 year-patient

2. Diagnosed as positive Helicobacter Pylori testing by any of the following methods:

   • Rapid urease test or Histology
3. Inform consent

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Once daily dose dexlansoprazole; Group 1 Dexlansoprazole 60 mg by oral once daily for 14 days (Levofloxacin 500 mg by oral once daily for 14 days Amoxicillin 1000 mg by oral bid for 14 days Bismuth 1048 mg by oral bid for 14 days)	Drug: Dexlansoprazole 60 mg once daily; 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
Active Comparator: Twice daily dose dexlansoprazole; Group 2 Dexlansoprazole 60 mg oral bid 14 Days (Levofloxacin 500 mg od oral 14 Days Amoxicillin 1000 mg bid oral 14 Days Bismuth 1048 mg bid oral 14 Days)	Drug: Dexlansoprazole 60 mg once daily; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Eradication rate (percentage)	Compare eradication rate of helicobacter pylori between 2 groups	Jan17-Nov17, Total 11 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To compare drug compliance	The investigators measure drug compliance between 2 groups, The investigators consider more than 85% of taking medications is a good compliance.	jan17-Nov17, Total 11 months
To compare drug adverse event	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.	jan17-Nov17, Total 11 months

Collaborators and Investigators

• Sponsor: Ramathibodi Hospital
• Investigators: Study Director: Akrawit Pulsombat, Doctor, Ramathibodi Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: February 9, 2017
• First Submitted That Met QC Criteria: March 15, 2017
• First Posted (Actual): March 22, 2017

Study Record Updates

• Last Update Posted (Actual): April 3, 2018
• Last Update Submitted That Met QC Criteria: April 2, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Dexlansoprazole; Lansoprazole
• Other Study ID Numbers: Psiriwat

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No