10 vs 14 Days Triple Therapy : H.Pylori Infection Eradication
Comparison of Triple Therapy Regimens Effectiveness Over 10 Days and 14 Days in Eradication of Helicobacter Pylori Infection: Double Blind Randomized Clinical Trial
1 other identifier
interventional
73
1 country
1
Brief Summary
Helicobacter pylori is a bacterium estimated to colonize in the gastrointestinal tract of the half population in the world. Colonization of this bacteria is suspected to be one of the main risk factor for the occurrence of various abnormalities of the upper gastrointestinal tract, such as peptic ulcer and gastrointestinal cancer. The Experts recommend giving triple therapy regimens as first-line eradication therapy for Helicobacter pylori infection. The recommended duration of triple therapy is 10-14 days. However, recent studies suggest triple therapy with longer duration will provide a higher percentage of eradication. This study wanted to show whether 14 days of triple therapy was better than 10 days in Helicobacter pylori eradication.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Oct 2016
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 3, 2016
CompletedFirst Submitted
Initial submission to the registry
April 25, 2017
CompletedFirst Posted
Study publicly available on registry
April 28, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 5, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 12, 2017
CompletedApril 28, 2017
April 1, 2017
7 months
April 25, 2017
April 27, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Eradication of Helicobacter pylori infection
Urea Breath Test after therapy
4 weeks after completed therapy
Study Arms (2)
14 days triple therapy
EXPERIMENTALRabeprazole Clarithromycin Amoxicillin
10 days triple therapy
PLACEBO COMPARATORRabeprazole Clarithromycin Amoxicillin
Interventions
Twice daily
Twice daily
Twice daily
Eligibility Criteria
You may qualify if:
- years or older patients who are proven to be infected by Helicobacter pylori based on positive in Urea Breath Test or positive in histopathologic examination of biopsy in antrum and corpus of gaster through esophagoduodenoscopy.
You may not qualify if:
- Patients refuse to follow the research
- Patient has had previous eradication therapy of Helicobacter pylori infection.
- The patient is pregnant or breastfeeding
- Patients have a history of allergy to one component of triple therapy regimen (proton pump inhibitor, penicillin, and / or macrolide) before.
- Patients are known to have impaired liver function, evidenced by ALT values within normal limits, and no previous liver disease.
- Patients were found to have arrhythmias or obtained QT wave elongation on electrocardiographic
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cipto Mangunkusumo Hospital
Jakarta Pusat, DKI Jakarta, 10430, Indonesia
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Randomized-double blinded Clinical Trials
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr. dr. SpPD, K-GEH, MMB, FACP
Study Record Dates
First Submitted
April 25, 2017
First Posted
April 28, 2017
Study Start
October 3, 2016
Primary Completion
May 5, 2017
Study Completion
May 12, 2017
Last Updated
April 28, 2017
Record last verified: 2017-04
Data Sharing
- IPD Sharing
- Will not share