Helicobacter Pylori Infection
Conditions
Keywords
dexlansoprazole MR, rabeprazole, Helicobacter pylori, triple therapy
Brief 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.
Interventions
DRUGdexlansoprazole based triple therapy
dexlansoprazole MR 60 mg once daily+clarithromycin 500 mg twice daily+ amoxicillin 1 g twice daily for 7 days
DRUGrabeprazole-based triple therapy
rabeprazole 20 mg twice daily + clarithromycin 500 mg twice daily + amoxicillin 1 g twice daily for 7 days
Sponsors
Kaohsiung Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or non-pregnant female aged more than 20 years. 2. H. pylori-infected outpatients 3. Mental and legal ability to give a written informed consent.
Exclusion criteria
1. previous H pylori-eradication therapy, 2. ingestion of antibiotics or bismuth within the prior 4 weeks, 3. patients with allergic history to the medications used, 4. patients with previous gastric surgery, 5. the coexistence of serious concomitant illness (for example, decompensated liver cirrhosis, uremia), 6. pregnant women.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The rate of H.pylori eradication | 6 weeks after finishing study drugs | Evaluate eradication outcome by 13C urea breath test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Drug Compliance | 6 weeks after finishing study drugs | Good drug compliance measured by number of subjects taking \>= 80% eradication medicines |
Countries
Taiwan
Outcome results
None listed