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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

177 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2015-08-31

Brief Summary

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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.

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Detailed Description

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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

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Helicobacter Pylori Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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dexlansoprazole based triple therapy

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

Group Type ACTIVE_COMPARATOR

dexlansoprazole based triple therapy

Intervention Type DRUG

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

rabeprazole-based triple therapy

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

Group Type EXPERIMENTAL

rabeprazole-based triple therapy

Intervention Type DRUG

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

Interventions

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dexlansoprazole based triple therapy

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

Intervention Type DRUG

rabeprazole-based triple therapy

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

Intervention Type DRUG

Other Intervention Names

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Dexilant-based triple therapy Pariet-based triple therapy

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No