Once Daily Dose Dexlansoprazole Quadruple Therapy for Helicobacter Pylori

Phase 4

Completed

• Conditions: H Pylori Eradication
• Interventions: Drug: Dexlansoprazole 60 mg once daily

• Registration Number: NCT03087162
• Lead Sponsor: Ramathibodi Hospital

Brief Summary

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.

Detailed Description

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

Study Timeline

• Study Start: 2017-01-01
• Study First Submitted: 2017-02-09
• Study First Submitted QC: 2017-03-15
• Study First Posted: 2017-03-22
• Primary Completion: 2017-12-01
• Study Completion: 2017-12-01
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-02
• Last Update Posted: 2018-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Once daily dose dexlansoprazole	Dexlansoprazole 60 mg once daily	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)
Twice daily dose dexlansoprazole	Dexlansoprazole 60 mg once daily	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)

Primary Outcome Measures

Name	Time	Method
Eradication rate (percentage)	Jan17-Nov17, Total 11 months	Compare eradication rate of helicobacter pylori between 2 groups

Secondary Outcome Measures

Name	Time	Method
To compare drug compliance	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.
To compare drug adverse event	jan17-Nov17, Total 11 months	The investigators measure adverse events as; 1. Nausea/Vomiting; 2. Abdominal pain/Abdominal discomfort/Abdominal Bloating; 3. Diarrhea/ Constipation; 4. Taste distortions; 5. Headache/Dizziness; 6. Rash/Itching/Drug allergy, Any symptoms occur new onset during taking medications, The investigators consider as an adverse events of an experiment.

Trial Locations

Locations (1)

Parin siriwat; 🇹🇭 Bangkok, Thailand