Sequential Versus Quadruple Therapy in the Second-line Treatment
NCT ID: NCT03208426
Last Updated: 2018-06-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
240 participants
INTERVENTIONAL
2017-10-01
2020-12-31
Brief Summary
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Detailed Description
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Interventions: eligible patients will be randomized into one of the two groups Group (A): sequential therapy for 14 days (S14)
D1-D7: (esomeprazole 40mg bid + amoxicillin 1000mg bid) for 7 days
D8-D14: (esomeprazole 40mg bid + clarithromycin 500mg bid + metronidazole 500mg bid) for another 7 days
Group (B): bismuth quadruple therapy for 10 days (Q10)
D1-D10: (esomeprazole 40mg bid + dibismuth trioxide 120mg qid + metronidazole 500mg tid + tetracycline 500mg qid) for 10 days
Primary End Point: Eradication rate in the second line treatment according to intention to treat (ITT) analysis in the two treatment groups
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Sequential therapy for 14 days
Sequential 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
Esomeprazole (S14)
Nexium, esomeprazole 40mg bid, 14 days
Amoxicillin (ST14)
Day 1-7 amoxicillin (Brand name: Amoxicillin Capsule) 1000mg bid for 7 days
Clarithromycin (ST14)
Klaricid-XL, clarithromycin, 500mg, bid, for 7 days, (day 8-14)
Metronidazole (ST14)
Flagyl, metronidazole, 500mg bid, for 7 days (day 8-14)
bismuth quadruple therapy for 10 days
Bismuth 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
Esomeprazole (BQ10)
Nexium, esomeprazole, 40mg bid for 10 days
dibismuth trioxide 120mg (BQ10)
KCB F.C. TABLETS, dibismuth trioxide 120mg qid for 10 days
Metronidazole (BQ10)
Flagyl, metronidazole 500mg tid for 10 days
tetracycline (BQ10)
Tetracycline (Brand name: Tetracycline Capsule ) 500mg qid for 10 days
Interventions
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Esomeprazole (S14)
Nexium, esomeprazole 40mg bid, 14 days
Esomeprazole (BQ10)
Nexium, esomeprazole, 40mg bid for 10 days
Amoxicillin (ST14)
Day 1-7 amoxicillin (Brand name: Amoxicillin Capsule) 1000mg bid for 7 days
Clarithromycin (ST14)
Klaricid-XL, clarithromycin, 500mg, bid, for 7 days, (day 8-14)
Metronidazole (ST14)
Flagyl, metronidazole, 500mg bid, for 7 days (day 8-14)
dibismuth trioxide 120mg (BQ10)
KCB F.C. TABLETS, dibismuth trioxide 120mg qid for 10 days
Metronidazole (BQ10)
Flagyl, metronidazole 500mg tid for 10 days
tetracycline (BQ10)
Tetracycline (Brand name: Tetracycline Capsule ) 500mg qid for 10 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
20 Years
ALL
Yes
Sponsors
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National Taiwan University Hospital
OTHER
Responsible Party
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Principal Investigators
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Jyh-Ming Liou, MD, PhD
Role: STUDY_CHAIR
National Taiwan University Hospital
Yu-Jen Fang, MD
Role: PRINCIPAL_INVESTIGATOR
National Taiwan University Hospital, Yun-Lin Branch
Locations
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Jyh-Ming Liou
Taipei, Taiwan, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Liou 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.
Other Identifiers
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201611053MINA
Identifier Type: -
Identifier Source: org_study_id
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