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Trial record 95 of 389 for:    CLARITHROMYCIN

Clarithromycin Triple Therapy Plus Bismuth for Helicobacter Pylori First-line Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02732249
Recruitment Status : Completed
First Posted : April 8, 2016
Last Update Posted : June 26, 2018
Sponsor:
Information provided by (Responsible Party):
Hong Lu, MD, Shanghai Jiao Tong University School of Medicine

Brief Summary:
Standard triple therapy including a proton pump inhibitor (PPI) and clarithromycin with either amoxicillin or metronidazole are no longer recommended as empirical first-line therapy to treat Helicobacter pylori infection because of high antibiotic resistance. It is unknown whether the addition of bismuth overcome antibiotic resistance. This study is designed to evaluate the efficacy and safety of the addition of bismuth to standard triple therapy for H. pylori first-line eradication.

Condition or disease Intervention/treatment Phase
Helicobacter Pylori Infection Drug: Esomeprazole Drug: Bismuth Potassium Citrate Drug: Clarithromycin Drug: Metronidazole Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Clinical Trial of Clarithromycin/Bismuth Containing Quadruple Therapy for Helicobacter Pylori First-line Treatment
Actual Study Start Date : April 1, 2016
Actual Primary Completion Date : September 30, 2017
Actual Study Completion Date : September 30, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Triple regimen group
Esomeprazole 20mg bid, clarithromycin 500mg bid and metronidazole 400mg qid for 14 days
Drug: Esomeprazole
Given 30 min before morning and evening meals

Drug: Clarithromycin
Given 30 min after morning and evening meals

Drug: Metronidazole
Given 30 min after meals or at bedtime

Experimental: Low metronidazole group
Esomeprazole 20mg bid, bismuth potassium citrate 600mg bid, clarithromycin 500mg bid and metronidazole 400mg bid for 14 days
Drug: Esomeprazole
Given 30 min before morning and evening meals

Drug: Bismuth Potassium Citrate
Given 30 min before morning and evening meals

Drug: Clarithromycin
Given 30 min after morning and evening meals

Drug: Metronidazole
Given 30 min after meals or at bedtime

Experimental: High metronidazole group
Esomeprazole 20mg bid, bismuth potassium citrate 600mg bid, clarithromycin 500mg bid and metronidazole 400mg qid for 14 days
Drug: Esomeprazole
Given 30 min before morning and evening meals

Drug: Bismuth Potassium Citrate
Given 30 min before morning and evening meals

Drug: Clarithromycin
Given 30 min after morning and evening meals

Drug: Metronidazole
Given 30 min after meals or at bedtime




Primary Outcome Measures :
  1. Helicobacter pylori eradication rate [ Time Frame: Six weeks after completion of therapy ]

Secondary Outcome Measures :
  1. Rate of adverse effects [ Time Frame: within 7 days after completion of therapy ]
  2. Compliance rate [ Time Frame: within 7 days after completion of therapy ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants with non-ulcer functional dyspepsia or scarred peptic ulcer disease
  • Ability and willingness to participate in the study and to sign and give informed consent
  • confirmed H. pylori infection

Exclusion Criteria:

  • Previous H. pylori eradication therapy
  • Less than 18 years old
  • With history of H. pylori infection treatment
  • With previous gastric surgery
  • Major systemic diseases
  • Pregnancy or lactation
  • Allergy to any of the study drugs
  • Administration of antibiotics, bismuth, antisecretory drugs in 8 weeks prior to inclusion

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): NCT02732249


Locations
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China, Shanghai
Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai, China, 200127
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
Investigators
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Principal Investigator: Hong lu, MD Renji Hospital, School of Medicine, Shanghai Jiao Tong University

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Responsible Party: Hong Lu, MD, Medical Doctor of Division of Gastroenterology and Hepatology of Renji Hospital, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT02732249     History of Changes
Other Study ID Numbers: rjkls2016068
First Posted: April 8, 2016    Key Record Dates
Last Update Posted: June 26, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Hong Lu, MD, Shanghai Jiao Tong University School of Medicine:
Helicobacter pylori
Clarithromycin
Amoxicillin
Metronidazole
Eradication
Additional relevant MeSH terms:
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Clarithromycin
Metronidazole
Potassium Citrate
Esomeprazole
Bismuth
Citric Acid
Sodium Citrate
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents
Anti-Bacterial Agents
Antiprotozoal Agents
Antiparasitic Agents
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Protein Synthesis Inhibitors
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Antacids
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Expectorants
Respiratory System Agents