Once Daily Dose Dexlansoprazole Quadruple Therapy for Helicobacter Pylori

Mahidol University

Status and phase: Completed; Phase 4

Conditions: H Pylori Eradication

Treatments: Drug: Dexlansoprazole 60 mg once daily

Study type: Interventional

Funder types: Other

Identifiers

NCT03087162

Psiriwat

Details and patient eligibility

About

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.

Full description

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

Enrollment: 180 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 2 patient groups

Once daily dose dexlansoprazole

Experimental group

Description:

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)

Treatment:

Drug: Dexlansoprazole 60 mg once daily

Twice daily dose dexlansoprazole

Active Comparator group

Description:

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)

Treatment:

Drug: Dexlansoprazole 60 mg once daily