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Trial record 6 of 14 for:    hong proton | Open Studies

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2017 by Shanghai Jiao Tong University School of Medicine
Sponsor:
Information provided by (Responsible Party):
Hong Lu, MD, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier:
NCT02732249
First received: April 4, 2016
Last updated: February 28, 2017
Last verified: February 2017
  Purpose
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 Intervention Phase
Helicobacter Pylori Infection
Drug: Esomeprazole
Drug: Bismuth Potassium Citrate
Drug: Clarithromycin
Drug: Metronidazole
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Outcomes Assessor
Primary Purpose: Treatment
Official Title: A Randomized Clinical Trial of Clarithromycin/Bismuth Containing Quadruple Therapy for Helicobacter Pylori First-line Treatment

Resource links provided by NLM:


Further study details as provided by Shanghai Jiao Tong University School of Medicine:

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

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

Estimated Enrollment: 393
Study Start Date: April 2016
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02732249

Contacts
Contact: Hong lu, MD 13611958022 hlu@sjtu.edu.cn

Locations
China, Shanghai
Renji Hospital, School of Medicine, Shanghai Jiao Tong University Recruiting
Shanghai, Shanghai, China, 200127
Contact: Huili Dai, Ph.D.    86-21-58752345      
Principal Investigator: Hong Lu, M.D.,Ph.D.         
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
Investigators
Principal Investigator: Hong lu, MD Renji Hospital, School of Medicine, Shanghai Jiao Tong University
  More Information

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
Study First Received: April 4, 2016
Last Updated: February 28, 2017
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Shanghai Jiao Tong University School of Medicine:
Helicobacter pylori
Clarithromycin
Amoxicillin
Metronidazole
Eradication

Additional relevant MeSH terms:
Proton Pump Inhibitors
Helicobacter Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Metronidazole
Clarithromycin
Esomeprazole
Bismuth
Potassium Citrate
Citric Acid
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents
Anti-Ulcer Agents
Gastrointestinal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents
Protein Synthesis Inhibitors
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Expectorants
Respiratory System Agents
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents

ClinicalTrials.gov processed this record on May 25, 2017