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

Kaohsiung Medical University

Status and phase: Completed; Phase 4

Conditions: Helicobacter Pylori Infection

Treatments: Drug: rabeprazole-based triple therapy; Drug: dexlansoprazole based triple therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02541786

KaohsiungMUH

Details and patient eligibility

About

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.

Full 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.

Enrollment: 177 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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177 participants in 2 patient groups

dexlansoprazole based triple therapy

Active Comparator group

Description:

dexlansoprazole MR 60 mg once daily, clarithromycin 500 mg twice daily, and amoxicillin 1 g twice daily for 7 days

Treatment:

Drug: dexlansoprazole based triple therapy

rabeprazole-based triple therapy

Experimental group

Description:

rabeprazole 20 mg twice daily, clarithromycin 500 mg twice daily, and amoxicillin 1 g twice daily for 7 days

Treatment:

Drug: rabeprazole-based triple therapy