Study Results
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Basic Information
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COMPLETED
NA
202 participants
INTERVENTIONAL
2017-03-01
2019-04-20
Brief Summary
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Recommended proton pump inhibitor (PPI)-clarithromycin-amoxicillin or metronidazole treatment for 7 to14 days is the first choice treatment for H pylori infection. The eradication rate of the standard triple therapy has generally declined to unacceptable levels (i.e., 80% or less) recently because the increasing incidence of clarithromycin-resistant strains of H. pylori. Standard triple therapies should be abandoned in the areas with clarithromycin resistance ≥ 20%. The investigators have proven that 7-day Concomitant therapy can achieve a promising success rate of \>90 % in the presence of clarithromycin resistance. However, high dose PPI is needed with a dosage of twice daily but when a dual delayed release formulation PPI in capsules for oral administration (Dexlansoprazole MR), a once daily dose may be needed only. The capsules contain dexlansoprazole in a mixture of two types of enteric-coated granules with different pH-dependent dissolution profiles. It suppresses gastric acid secretion via inhibition of the proton pump in the gastric parietal cell, which blocks the final step of acid production. Thus, it improves acid suppression and offer benefits over conventional single release PPI formulations. by prolonging optimal plasma concentration and create a favorable condition H. pylori eradication
Aim:
The efficacy of Dexlansoprazole MR-based concomitant quadruple therapy
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Detailed Description
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Recommended proton pump inhibitor (PPI)-clarithromycin-amoxicillin or metronidazole treatment for 7 to14 days is the first choice treatment for H pylori infection. The eradication rate of the standard triple therapy has generally declined to unacceptable levels (i.e., 80% or less) recently because the increasing incidence of clarithromycin-resistant strains of H. pylori. Standard triple therapies should be abandoned in the areas with clarithromycin resistance ≥ 20%. The investigators have proven that 7-day Concomitant therapy can achieve a promising success rate of \>90% in the presence of clarithromycin resistance. However, high dose PPI is needed with a dosage of twice daily but when a dual delayed release formulation PPI in capsules for oral administration (Dexlansoprazole MR), a once daily dose may be needed only. The capsules contain dexlansoprazole in a mixture of two types of enteric-coated granules with different pH-dependent dissolution profiles. It suppresses gastric acid secretion via inhibition of the proton pump in the gastric parietal cell, which blocks the final step of acid production. Thus, it improves acid suppression and offer benefits over conventional single release PPI formulations. by prolonging optimal plasma concentration and create a favorable condition H. pylori eradication
Aim:
The efficacy of Dexlansoprazole MR-based concomitant quadruple therapy
Methods:
Two hundred and two consecutive H. pylori-infected participants are randomly assigned to a 7-day Dexlansoprazole MR-based non-bismuth quadruple therapy (Dexlansoprazole MR 60 mg qd.,clarithromycin 500 mg bid., amoxicillin 1 g bid. and metronidazole 500 mg bid. for 7 days) or a 7-day lansoprazole-based non-bismuth quadruple therapy (Lansoprazole 30 mg bid. , clarithromycin 500 mg bid., amoxicillin 1 g bid. and metronidazole 500 mg bid. for 7 days). Participants are asked to return at the 2nd week to assess drug compliance and adverse events. Repeated endoscopy with rapid urease test, histological examination is performed at the 8th week after the end of anti- H. pylori therapy. If participants refuse follow-up endoscopy, urea breath tests are conducted to assess H. pylori status. The rates of eradication are analyzed by intention-to-treat and per-protocol analysis.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Dexlansoprazole MR group
Dexlansoprazole MR 60 mg qd.,clarithromycin 500 mg bid., amoxicillin 1 g bid. and metronidazole 500 mg bid. for 7 days
Dexlan
Dexlansoprazole MR 60 mg qd for 7 days
Amoxicillin
Amoxicillin (Amolin) 1 g bid. for 7 days
Clarithromycin 500mg
clarithromycin (Klaricid) 500 mg bid for 7 days
Metronidazole
Metronidazole (Flagyl) 500 mg bid daily for 7 days
lansoprazole group
Lansoprazole 30 mg bid., clarithromycin 500 mg bid., amoxicillin 1 g bid. and metronidazole 500 mg bid. for 7 days
Dexlan
Dexlansoprazole MR 60 mg qd for 7 days
Amoxicillin
Amoxicillin (Amolin) 1 g bid. for 7 days
Clarithromycin 500mg
clarithromycin (Klaricid) 500 mg bid for 7 days
Metronidazole
Metronidazole (Flagyl) 500 mg bid daily for 7 days
Interventions
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Dexlan
Dexlansoprazole MR 60 mg qd for 7 days
Amoxicillin
Amoxicillin (Amolin) 1 g bid. for 7 days
Clarithromycin 500mg
clarithromycin (Klaricid) 500 mg bid for 7 days
Metronidazole
Metronidazole (Flagyl) 500 mg bid daily for 7 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
2. ingestion of antibiotics, bismuth, or PPIs within the prior 4 weeks
3. patients with allergic history to the medications used
4. patients with previous gastric surgery
5. the coexistence of serious concomitant illness (for example, decompensated liver cirrhosis, uremia)
6. pregnant women.
18 Years
80 Years
ALL
No
Sponsors
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Chang Gung Memorial Hospital
OTHER
Responsible Party
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Seng-Kee Chuah
Professor
Principal Investigators
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Seng-Kee Chuah, MD
Role: PRINCIPAL_INVESTIGATOR
Kaohsiung Chang Gung Memorial Hospital,Taiwan
Locations
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Kaohsiung Chang Gung Memorial Hospital,Taiwan
Kaohsiung City, , Taiwan
Countries
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References
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Tai WC, Liang CM, Bi KW, Kuo CM, Lu LS, Wu CK, Yang SC, Kuo YH, Lee CH, Huang CF, Hsu CN, Hsu PI, Wu DC, Hu TH, Wu KL, Chuah SK. A comparison between dexlansoprazole modified release-based and lansoprazole-based nonbismuth quadruple (concomitant) therapy for first-line Helicobacter pylori eradication: a prospective randomized trial. Infect Drug Resist. 2019 Sep 16;12:2923-2931. doi: 10.2147/IDR.S213998. eCollection 2019.
Other Identifiers
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CMRPG8F1421
Identifier Type: -
Identifier Source: org_study_id
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