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

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.

Study Overview

• Status: Completed
• Conditions: Helicobacter Pylori Infection
• Intervention / Treatment: Drug: dexlansoprazole based triple therapy; Drug: rabeprazole-based triple therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 177
• Phase: Phase 4

Contacts and Locations

Study Locations

• Taiwan
  • Kaohsiung, Taiwan, 807
    • Kaohsiung Medical University Hospital
  • Kaohsiung, Taiwan, 813
    • Kaohsiung Veterans General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: dexlansoprazole based triple therapy; dexlansoprazole MR 60 mg once daily, clarithromycin 500 mg twice daily, and amoxicillin 1 g twice daily for 7 days	Drug: dexlansoprazole based triple therapy; dexlansoprazole MR 60 mg once daily+clarithromycin 500 mg twice daily+ amoxicillin 1 g twice daily for 7 days; Other Names: Dexilant-based triple therapy
Experimental: rabeprazole-based triple therapy; rabeprazole 20 mg twice daily, clarithromycin 500 mg twice daily, and 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; Other Names: Pariet-based triple therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The rate of H.pylori eradication	Evaluate eradication outcome by 13C urea breath test	6 weeks after finishing study drugs

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Drug Compliance	Good drug compliance measured by number of subjects taking >= 80% eradication medicines	6 weeks after finishing study drugs

Collaborators and Investigators

• Sponsor: Kaohsiung Medical University
• Investigators: Study Chair: Deng-Chyang Wu, MD, PHD, Kaohsiung Medical University

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: August 27, 2015
• First Submitted That Met QC Criteria: September 1, 2015
• First Posted (Estimate): September 4, 2015

Study Record Updates

• Last Update Posted (Estimate): September 4, 2015
• Last Update Submitted That Met QC Criteria: September 1, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: Helicobacter pylori; triple therapy; rabeprazole; dexlansoprazole MR
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Communicable Diseases; Helicobacter Infections; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Dexlansoprazole; Lansoprazole; Rabeprazole
• Other Study ID Numbers: KaohsiungMUH