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Trial record 43 of 214 for:    TETRACYCLINE

Efficacies of Two Bismuth Quadruple Therapies in the Second-line Treatment of H Pylori Infection

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ClinicalTrials.gov Identifier: NCT03779087
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:
From the profiles of antibiotic susceptibility data following eradication therapy, tetracycline, amoxicillin and levofloxacin are all good candidates of antibiotics used in the rescue treatment.

Condition or disease Intervention/treatment Phase
Helicobacter Pylori Infection Drug: 10d TL quadruple therapy Drug: 10d AL quadruple therapy Not Applicable

Detailed Description:
The H pylori-infected adult patients with failure of standard triple therapy and H pylori-infected adult patients with failure of non-bismuth quadruple therapy are randomly assigned to either TL quadruple therapy (esomeprazole-bismuth-tetracycline-levofloxacin regimen) or AL quadruple therapy (esomeprazole-bismuth-amoxicillin-levofloxacin regimen) for 10 days. Repeated endoscopy with rapid urease test, histological examination and culture or urea breath tests is performed at six weeks after the end of anti-H pylori therapy.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 184 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacies of Two Bismuth Quadruple Therapies in the Second-line Treatment of H Pylori Infection — a Multi-center Randomized Controlled Trial
Actual Study Start Date : July 11, 2018
Estimated Primary Completion Date : July 11, 2020
Estimated Study Completion Date : December 31, 2020

Arm Intervention/treatment
Experimental: 10d TL quadruple therapy
esomeprazole 40 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 TL quadruple therapy
esomeprazole 40 mg bid., tripotassium dicitrate bismuthate 300mg qid, tetracycline 500 mg qid, levofloxacin 500 mg qd.
Other Names:
  • esomeprazole 40 mg
  • tripotassium dicitrate bismuthate 300mg
  • tetracycline 500 mg
  • levofloxacin 500 mg

Active Comparator: 10d AL quadruple therapy
esomeprazole 40 mg b.i.d. plus tripotassium dicitrate bismuthate 300 mg, amoxicillin 500 mg and metronidazole 250 mg q.i.d. for 10 days
Drug: 10d AL quadruple therapy
esomeprazole 40 mg bid., tripotassium dicitrate bismuthate 300mg qid, amoxicillin 500 mg qid, levofloxacin 500 mg qd.
Other Names:
  • esomeprazole 40 mg
  • tripotassium dicitrate bismuthate 300mg
  • amoxicillin 500 mg
  • levofloxacin 500 mg




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 failure of first-line eradication treatments (standard triple, non-bismuth quadruple and bismuth quadruple therapies)

Exclusion Criteria:

  • previous allergic reactions to the study medications,
  • history of gastrectomy,
  • use of antibiotics within the previous 4 weeks,
  • pregnant or lactating women,
  • coexistence of serious concomitant illness (for example, decompensated liver cirrhosis, uremia, and malignancy).

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): NCT03779087


Contacts
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Contact: Ping-I Hsu, Bachelor +886-7-342-2121 ext 8233 williamhsup@yahoo.com.tw

Locations
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Taiwan
Kaohsiung Veterans General Hospital Recruiting
Kaohsiung, Taiwan, 813
Contact: Ping I Hsu, MD         
Sponsors and Collaborators
Ping-I (William) Hsu, M.D.
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: NCT03779087     History of Changes
Other Study ID Numbers: VGHKS18-CT7-22
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
Rescue treatment
Additional relevant MeSH terms:
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Tetracycline
Infection
Communicable Diseases
Amoxicillin
Levofloxacin
Ofloxacin
Esomeprazole
Bismuth
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Antacids
Protein Synthesis Inhibitors