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Comparing the Efficacy of Hybrid, High-dose Dual and Bismuth Quadruple Therapies

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ClinicalTrials.gov Identifier: NCT03779074
Recruitment Status : Recruiting
First Posted : December 18, 2018
Last Update Posted : December 18, 2018
Sponsor:
Information provided by (Responsible Party):
Ping-I (William) Hsu, M.D., Kaohsiung Veterans General Hospital.

Brief Summary:
Both hybrid and high-dose dual therapies developed by the scholars from Taiwan can achieve a high eradication rate for clarithromycin-resistant strains, and have a great potential to replace bismuth quadruple therapy in the treatment of H. pylori infection.

Condition or disease Intervention/treatment Phase
Helicobacter Pylori Infection Drug: 10d bismuth quadruple therapy Drug: 14d hybrid therapy Drug: 14D high-dose dual therapy Phase 3

Detailed Description:
Bismuth quadruple therapy has been recommended as a choice of the first-line treatment for H. pylori infection in several important international consensuses. However, it is associated with a high frequency of adverse events. Both hybrid and high-dose dual therapies developed by the scholars from Taiwan can achieve a high eradication rate for clarithromycin-resistant strains, and have a great potential to replace bismuth quadruple therapy in the treatment of H. pylori infection. In the second-line treatment, tetracycline-levofloxacin quadruple therapy developed by our study group can achieve a higher eradication rate than levofloxacin triple therapy for salvage treatment of hybrid therapy. However, whether the new therapy can be a promising rescue treatment for bismuth quadruple or high-dose dual therapy remains unanswered.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 918 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacies of Hybrid, High-dose Dual and Bismuth Quadruple Therapies for the First-line Anti-H Pylori Treatment and Tetracycline-levofloxacin Quadruple Therapy for the Second-line Anti-H Pylori Treatment — a Multicentre Randomized Trial
Actual Study Start Date : September 3, 2018
Estimated Primary Completion Date : July 3, 2020
Estimated Study Completion Date : December 31, 2020

Arm Intervention/treatment
Active Comparator: 10d bismuth quadruple therapy
rabeprazole 20 mg b.i.d. plus tripotassium dicitrate bismuthate 300 mg, tetracycline 500 mg and metronidazole 250 mg q.i.d. for 10 days.
Drug: 10d bismuth quadruple therapy
rabeprazole 20 mg b.i.d. plus tripotassium dicitrate bismuthate 300 mg, tetracycline 500 mg and metronidazole 250 mg q.i.d. for 10 days
Other Names:
  • rabeprazole 20 mg bid
  • tripotassium dicitrate bismuthate 300mg qid
  • tetracycline 500 mg qid
  • metronidazole 250 mg qid

Experimental: 14d hybrid therapy
a dual regimen with rabeprazole 20 mg and amoxicillin 1 g b.i.d. for 7 days followed by a quadruple regimen with rabeprazole 20 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg b.i.d. for 7 days.
Drug: 14d hybrid therapy
a dual regimen with rabeprazole 20 mg and amoxicillin 1 g b.i.d. for 7 days followed by a quadruple regimen with rabeprazole 20 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg b.i.d. for 7 days
Other Names:
  • rabeprazole 20 mg bid
  • amoxicillin 1 g bid
  • clarithromycin 500 mg bid
  • metronidazole 500 mg bid

Experimental: 14d high-dose dual therapy
rabeprazole 20 mg and amoxicillin 750 mg q.i.d. for 14 days
Drug: 14D high-dose dual therapy
rabeprazole 20 mg and amoxicillin 750 mg q.i.d. for 14 days
Other Names:
  • rabeprazole 20 mg qid
  • amoxicillin 750 mg qid




Primary Outcome Measures :
  1. Number of Participants in Which H. Pylori Was Eradicated [ Time Frame: sixth week after the end of anti- H. pylori therapy ]
    To assess eradication efficacy,repeated endoscopy with rapid urease test, histological



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Ages Eligible for Study:   20 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Consecutive H pylori-infected outpatients, at least 20 years of age, with endoscopically proven peptic ulcer diseases or gastritis

Exclusion Criteria:

  • previous H pylori-eradication therapy
  • ingestion of antibiotics or bismuth within the prior 4 weeks
  • patients with allergic history to the medications used
  • patients with previous gastric surgery
  • the coexistence of serious concomitant illness (for example, decompensated liver cirrhosis, uremia)
  • pregnant women

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03779074


Contacts
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Contact: Ping-I Hsu, Bachelor +886-7-342-2121 ext 8233 williamhsup@yahoo.com.tw
Contact: Feng-woei Tsay, Bachelor +886-7-342-2121 ext 8233 fwchaie@vghks.gov.tw

Locations
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Taiwan
Kaohsiung Veterans General Hospital Recruiting
Kaohsiung, Taiwan, 813
Contact: Ping I Hsu, MD    886-7346-8233    williamhsup@yahoo.com.tw   
Sponsors and Collaborators
Kaohsiung Veterans General Hospital.
Investigators
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Study Chair: Ping-I Hsu, Bachelor Kaohsiung Veterans General Hospital.

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Responsible Party: Ping-I (William) Hsu, M.D., Professor, Kaohsiung Veterans General Hospital.
ClinicalTrials.gov Identifier: NCT03779074     History of Changes
Other Study ID Numbers: VGHKS18-CT4-24
First Posted: December 18, 2018    Key Record Dates
Last Update Posted: December 18, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ping-I (William) Hsu, M.D., Kaohsiung Veterans General Hospital.:
Helicobacter pylori
Eradication rate

Additional relevant MeSH terms:
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Helicobacter Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Amoxicillin
Metronidazole
Clarithromycin
Tetracycline
Rabeprazole
Bismuth
Anti-Bacterial Agents
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Antacids