High Dose Dual Therapy (HDDT) for Eradication of Helicobacter Pylori Infection
HDDT
1 other identifier
interventional
300
1 country
1
Brief Summary
The investigators will performed a large-scale multi center trial to compare the efficacy of a high-dose dual therapy (HDDT) with that of standard therapies in treatment-naive (n = 300) patients with Hp infection. Consecutive symptomatic patients will be recruited in Israel and Spain when tested positive to Hp with serology and 13C urea breath test (13C-UBT) due to symptoms. Patients with gastric cancer, MALT lymphoma, and younger than 18 or older than 80 years old will be excluded. All patients will be naive to eradication therapy and will be randomized into one of three groups: Group 1: Nexium 40 mg and amoxicillin 1.5 gr twice daily for 14 days Group 2: Nexium 40 mg and doxycycline 200 mg twice a day Group 3: Triple therapy of Nexium 20 mg, clarythromycin 500 mg, and amoxicillin 1gr twice a day for 10 days (regular accepted treatment). All treatments will be stopped for a month and then 13CUBT will be repeated. The primary aim of the study is to assess eradication success, intentioned to treat and per protocol in the three treatment regimens. The secondary aim of the study is to assess the safety of high dose amoxicillin and doxycycline.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Oct 2015
Longer than P75 for phase_4
1 active site
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
First Submitted
Initial submission to the registry
July 26, 2015
CompletedFirst Posted
Study publicly available on registry
September 17, 2015
CompletedStudy Start
First participant enrolled
October 22, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedJanuary 31, 2018
January 1, 2018
4.9 years
July 26, 2015
January 29, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Eradication rate
Eradication rate
2 weeks therapy
Study Arms (3)
Group 1
ACTIVE COMPARATORNexium 40 mg and amoxicillin 1.5 gr twice daily for 14 days
Group 2
ACTIVE COMPARATORNexium 40 mg and doxycycline 200 mg twice daily for 14 days
Group 3
ACTIVE COMPARATORNexium 20 mg, clarythromicin 500 mg, and amoxicillin 1 gr twice daily for 14 days
Interventions
Eligibility Criteria
You may qualify if:
- Patients infected with Helicobacter pylori
You may not qualify if:
- Patients with gastric cancer or MALT lymphoma
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rabin Medical Center
Petah Tikva, 49100, Israel
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yaron Niv, MD
RMC
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief of Gastroenterology, Deputy CEO RMC
Study Record Dates
First Submitted
July 26, 2015
First Posted
September 17, 2015
Study Start
October 22, 2015
Primary Completion
September 1, 2020
Study Completion
December 1, 2021
Last Updated
January 31, 2018
Record last verified: 2018-01