Sequential Versus Quadruple Therapy in the Second-line Treatment
Comparison of the Efficacy of 14-day Sequential Therapy and 10-day Bismuth Quadruple Therapy in the Second Line Therapy for Helicobacter Pylori Infection: A Multi-center Randomized Trial
1 other identifier
interventional
240
1 country
1
Brief Summary
Objectives: A recent randomized trial showed that 14-day sequential therapy containing high dose proton pump inhibitor was higher than 95% in the first line treatment. However, whether the 14-day sequential therapy is more effective than 10-day bismuth quadruple therapy remains unknown. Therefore, the investigators aimed to compare the eradication rates and long term re-infection rates of sequential therapy for 14 days versus bismuth quadruple therapy for 10 days in the second line treatment.
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 2017
Typical duration 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
May 21, 2017
CompletedFirst Posted
Study publicly available on registry
July 5, 2017
CompletedStudy Start
First participant enrolled
October 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedJune 4, 2018
June 1, 2018
2.2 years
May 21, 2017
June 1, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
eradication rate in the second-line treatment according to intention to treat (ITT) analysis
Urea breath test will be performed at least 6 weeks after the end of eradication therapy. Successful eradication of H. pylori will be defined as a negative 13C-UBT result. A positive 13C-UBT test will be defined as a delta value of 4 units or greater. All subjects will be asked to stop PPI and H2-blocker for at least two weeks before 13C-UBT.
6 weeks
Secondary Outcomes (4)
Incidence of adverse effects in the first line therapy in the two treatment groups
2 weeks
Eradication rates in the second line treatment according to per protocol (PP) analysis
6 weeks
Changes of gut microbiota in the two treatment groups
2 weeks, 8 weeks, and 1 year
Re-infection rate one year after eradication therapy
1 year
Study Arms (2)
Sequential therapy for 14 days
EXPERIMENTALSequential therapy for 14 days (experimental) D1-D7: (Nexium, esomeprazole 40mg bid + amoxicillin (Brand name: Amoxicillin Capsule) 1000mg bid) for 7 days D8-D14: (Nexium, esomeprazole 40mg bid + Klaricid XL, clarithromycin 500mg bid + Flagyl, metronidazole 500mg bid) for another 7 days
bismuth quadruple therapy for 10 days
ACTIVE COMPARATORBismuth quadruple therapy for 10 days (active comparator) D1-D10: (Nexium, esomeprazole 40mg bid + KCB F.C. TABLETS, dibismuth trioxide 120mg qid + Flagyl, metronidazole 500mg tid + tetracycline (Brand name: Tetracycline Capsule ) 500mg qid) for 10 days
Interventions
Nexium, esomeprazole 40mg bid, 14 days
Nexium, esomeprazole, 40mg bid for 10 days
Day 1-7 amoxicillin (Brand name: Amoxicillin Capsule) 1000mg bid for 7 days
Klaricid-XL, clarithromycin, 500mg, bid, for 7 days, (day 8-14)
Flagyl, metronidazole, 500mg bid, for 7 days (day 8-14)
KCB F.C. TABLETS, dibismuth trioxide 120mg qid for 10 days
Flagyl, metronidazole 500mg tid for 10 days
Tetracycline (Brand name: Tetracycline Capsule ) 500mg qid for 10 days
Eligibility Criteria
You may qualify if:
- H. pylori infected patients who fail from first line standard triple therapy with clarithromycin, amoxicillin, and a proton pump inhibitor will be eligible in this study.
You may not qualify if:
- Patients will be excluded from the study if any one of the following criteria was present:
- children and teenagers aged less than 20 years,
- history of gastrectomy,
- gastric malignancy, including adenocarcinoma and lymphoma,
- previous allergic reaction to antibiotics (bismuth, metronidazole, levofloxacin, tetracycline) and PPI (esomeprazole),
- contraindication to treatment drugs,
- pregnant or lactating women,
- severe concurrent disease, or
- Unwilling to accept random assignment of subjects.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Jyh-Ming Liou
Taipei, Taiwan, 10002, Taiwan
Related Publications (2)
Liou JM, Fang YJ, Chen CC, Bair MJ, Chang CY, Lee YC, Chen MJ, Chen CC, Tseng CH, Hsu YC, Lee JY, Yang TH, Luo JC, Chang CC, Chen CY, Chen PY, Shun CT, Hsu WF, Hu WH, Chen YN, Sheu BS, Lin JT, Wu JY, El-Omar EM, Wu MS; Taiwan Gastrointestinal Disease and Helicobacter Consortium. Concomitant, bismuth quadruple, and 14-day triple therapy in the first-line treatment of Helicobacter pylori: a multicentre, open-label, randomised trial. Lancet. 2016 Nov 12;388(10058):2355-2365. doi: 10.1016/S0140-6736(16)31409-X. Epub 2016 Oct 18.
PMID: 27769562RESULTLiou JM, Chen CC, Chen MJ, Chen CC, Chang CY, Fang YJ, Lee JY, Hsu SJ, Luo JC, Chang WH, Hsu YC, Tseng CH, Tseng PH, Wang HP, Yang UC, Shun CT, Lin JT, Lee YC, Wu MS; Taiwan Helicobacter Consortium. Sequential versus triple therapy for the first-line treatment of Helicobacter pylori: a multicentre, open-label, randomised trial. Lancet. 2013 Jan 19;381(9862):205-13. doi: 10.1016/S0140-6736(12)61579-7. Epub 2012 Nov 16.
PMID: 23158886RESULT
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jyh-Ming Liou, MD, PhD
National Taiwan University Hospital
- PRINCIPAL INVESTIGATOR
Yu-Jen Fang, MD
National Taiwan University Hospital, Yun-Lin Branch
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- The technicians who performed the UBT test are blind to the treatment allocation
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 21, 2017
First Posted
July 5, 2017
Study Start
October 1, 2017
Primary Completion
December 31, 2019
Study Completion
December 31, 2020
Last Updated
June 4, 2018
Record last verified: 2018-06
Data Sharing
- IPD Sharing
- Will not share