NCT02541786

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 177 (actual)
• Sponsor: Kaohsiung Medical University · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Helicobacter Pylori Infection

Interventions

Type	Name	Description
DRUG	dexlansoprazole based triple therapy	dexlansoprazole MR 60 mg once daily+clarithromycin 500 mg twice daily+ amoxicillin 1 g twice daily for 7 days
DRUG	rabeprazole-based triple therapy	rabeprazole 20 mg twice daily + clarithromycin 500 mg twice daily + amoxicillin 1 g twice daily for 7 days

Timeline

• Start date: 2015-01-01
• Primary completion: 2015-06-01
• Completion: 2015-08-01
• First posted: 2015-09-04
• Last updated: 2015-09-04

Locations

2 sites across 1 country: Taiwan