Comparison of Dexlansoprazole-based Triple and Rabeprazole-based Triple Therapies for Helicobacter Pylori Infection
1 other identifier
interventional
177
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jan 2015
Shorter than P25 for phase_4
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedFirst Submitted
Initial submission to the registry
August 27, 2015
CompletedFirst Posted
Study publicly available on registry
September 4, 2015
CompletedSeptember 4, 2015
September 1, 2015
5 months
August 27, 2015
September 1, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The rate of H.pylori eradication
Evaluate eradication outcome by 13C urea breath test
6 weeks after finishing study drugs
Secondary Outcomes (1)
Drug Compliance
6 weeks after finishing study drugs
Study Arms (2)
dexlansoprazole based triple therapy
ACTIVE COMPARATORdexlansoprazole MR 60 mg once daily, clarithromycin 500 mg twice daily, and amoxicillin 1 g twice daily for 7 days
rabeprazole-based triple therapy
EXPERIMENTALrabeprazole 20 mg twice daily, clarithromycin 500 mg twice daily, and amoxicillin 1 g twice daily for 7 days
Interventions
dexlansoprazole MR 60 mg once daily+clarithromycin 500 mg twice daily+ amoxicillin 1 g twice daily for 7 days
rabeprazole 20 mg twice daily + clarithromycin 500 mg twice daily + amoxicillin 1 g twice daily for 7 days
Eligibility Criteria
You may qualify if:
- Male or non-pregnant female aged more than 20 years.
- H. pylori-infected outpatients
- Mental and legal ability to give a written informed consent.
You may not qualify if:
- previous H pylori-eradication therapy,
- ingestion of antibiotics or bismuth within the prior 4 weeks,
- patients with allergic history to the medications used,
- patients with previous gastric surgery,
- the coexistence of serious concomitant illness (for example, decompensated liver cirrhosis, uremia),
- pregnant women.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Kaohsiung Medical University Hospital
Kaohsiung City, 807, Taiwan
Kaohsiung Veterans General Hospital
Kaohsiung City, 813, Taiwan
Study Officials
- STUDY CHAIR
DENG-CHYANG WU, MD, PHD
Kaohsiung Medical University
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Professor
Study Record Dates
First Submitted
August 27, 2015
First Posted
September 4, 2015
Study Start
January 1, 2015
Primary Completion
June 1, 2015
Study Completion
August 1, 2015
Last Updated
September 4, 2015
Record last verified: 2015-09