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Trial record 63 of 214 for:    TETRACYCLINE

Comparing the Efficacy of Reverse Hybrid Therapy and Bismuth Quadruple Therapy

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ClinicalTrials.gov Identifier: NCT02547038
Recruitment Status : Completed
First Posted : September 11, 2015
Results First Posted : June 10, 2019
Last Update Posted : June 10, 2019
Sponsor:
Information provided by (Responsible Party):
Ping-I (William) Hsu, M.D., Kaohsiung Veterans General Hospital.

Brief Summary:
Reverse hybrid therapy achieves a higher eradication rate than bismuth quadruple therapy remained unanswered.

Condition or disease Intervention/treatment Phase
Helicobacter Pylori Infection Drug: pantoprazole+bismuth+tetra+metro Drug: (panto+amox+clar+metr)+(panto+amox) Not Applicable

Detailed Description:
A 14-day hybrid therapy invented by our study group appears very promising in H. pylori eradication, achieving excellent eradication rates of 99% and 97% according to per-protocol and intention-to-treat analyses, respectively. Recently, the investigators demonstrated that the eradication rate of reverse hybrid therapy was higher than that of standard triple therapy. However, whether reverse hybrid therapy achieves a higher eradication rate than bismuth quadruple therapy remained unanswered.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 352 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Comparing the Efficacy and Impact on Gastrointestinal Microbiome of Reverse Hybrid Therapy and Bismuth Quadruple Therapy in Helicobacter Pylori Eradication
Study Start Date : February 2015
Actual Primary Completion Date : October 2018
Actual Study Completion Date : October 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: pantoprazole+bismuth+tetra+metro
pantoprazole 40 mg twice daily, bismuth subcitrate 120 mg four times daily, and tetracycline 500 mg four times daily, and metronidazole 250 mg four times daily for 14 days
Drug: pantoprazole+bismuth+tetra+metro
pantoprazole 40 mg twice daily, bismuth subcitrate 120 mg four times daily, and tetracycline 500 mg four times daily, and metronidazole 250 mg four times daily for 14 days
Other Names:
  • pantoprazole 40 mg
  • bismuth subcitrate 120 mg
  • tetracycline 500 mg
  • metronidazole 250 mg

Active Comparator: (panto+amox+clar+metr)+(panto+amox)
a 7-day quadruple regimen with pantoprazole 40 mg twice daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily, followed by a 7-day dual regimen with pantoprazole 40 mg twice daily and amoxicillin 1 g twice daily
Drug: (panto+amox+clar+metr)+(panto+amox)
a 7-day quadruple regimen with pantoprazole 40 mg twice daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily, followed by a 7-day dual regimen with pantoprazole 40 mg twice daily and amoxicillin 1 g twice daily
Other Names:
  • pantoprazole 40 mg
  • amoxicillin 1 g
  • clarithromycin 500 mg
  • metronidazole 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 ]
    Evaluate eradication outcome by endoscopy urease test and histology or urea breath test (Number of Participants With Complete Eradication of Helicobacter Pylori)



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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): NCT02547038


Locations
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Taiwan
Kaohsiung Veterans General Hospital
Kaohsiung, Taiwan, 813
Sponsors and Collaborators
Kaohsiung Veterans General Hospital.
Investigators
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Study Chair: Ping-I Hsu, Bachelor Kaohsiung Veterans General Hospital.
  Study Documents (Full-Text)

Documents provided by Ping-I (William) Hsu, M.D., Kaohsiung Veterans General Hospital.:

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ping-I (William) Hsu, M.D., Professor, Kaohsiung Veterans General Hospital.
ClinicalTrials.gov Identifier: NCT02547038     History of Changes
Other Study ID Numbers: VGHKS15-CT2-10
First Posted: September 11, 2015    Key Record Dates
Results First Posted: June 10, 2019
Last Update Posted: June 10, 2019
Last Verified: March 2019
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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Tetracycline
Amoxicillin
Metronidazole
Clarithromycin
Bismuth tripotassium dicitrate
Pantoprazole
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