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Trial record 12 of 22 for:    "Bacterial Infectious Disease" | "Guaifenesin"

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.

Tracking Information
First Submitted Date  ICMJE December 16, 2018
First Posted Date  ICMJE December 18, 2018
Last Update Posted Date December 18, 2018
Actual Study Start Date  ICMJE September 3, 2018
Estimated Primary Completion Date July 3, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 16, 2018)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparing the Efficacy of Hybrid, High-dose Dual and Bismuth Quadruple Therapies
Official Title  ICMJE 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
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Helicobacter Pylori Infection
Intervention  ICMJE
  • 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
  • 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
  • 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
Study Arms  ICMJE
  • 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.
    Intervention: Drug: 10d bismuth quadruple therapy
  • 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.
    Intervention: Drug: 14d hybrid therapy
  • Experimental: 14d high-dose dual therapy
    rabeprazole 20 mg and amoxicillin 750 mg q.i.d. for 14 days
    Intervention: Drug: 14D high-dose dual therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 16, 2018)
918
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2020
Estimated Primary Completion Date July 3, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03779074
Other Study ID Numbers  ICMJE VGHKS18-CT4-24
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ping-I (William) Hsu, M.D., Kaohsiung Veterans General Hospital.
Study Sponsor  ICMJE Kaohsiung Veterans General Hospital.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Ping-I Hsu, Bachelor Kaohsiung Veterans General Hospital.
PRS Account Kaohsiung Veterans General Hospital.
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP