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Comparison of 7-day PPI-based Standard Triple Therapy and 10-day Bismuth Quadruple Therapy for H. Pylori Eradication

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ClinicalTrials.gov Identifier: NCT02557932
Recruitment Status : Completed
First Posted : September 23, 2015
Last Update Posted : April 8, 2020
Sponsor:
Information provided by (Responsible Party):
Il Ju Choi, National Cancer Center, Korea

Brief Summary:
In this randomized controlled trial, we investigate the effect of 10-day bismuth quadruple therapy in comparison with that of 7-day PPI-based standard triple as 1st line treatment for H. pylori.

Condition or disease Intervention/treatment Phase
Helicobacter Pylori Infection Family History of Stomach Cancer Drug: Standard triple therapy Drug: Bismuth quadruple therapy Phase 3

Detailed Description:
Current Helicobacter pylori management guidelines recommend proton-pump inhibitor (PPI)-Clarithromycin containing triple therapy as 1st line treatment. However, in Korea, eradication rates of PPI-Clarithromycin containing triple therapy have been decreased to less than 80% due to increased clarithromycin resistance. In areas of high clarithromycin resistance (resistance rate more than 15%), guidelines recommend bismuth quadruple therapy as a 1st line treatment for H. pylori eradication. Clarithromycin resistance rates reported from 15.7% to 42.1% in Korea, thus, bismuth quadruple therapy may be better 1st line treatment than PPI-Clarithromycin containing triple therapy. However, only one limited study was performed to compare effects of the both treatment regimens in Korea. Thus, studies evaluating the effect of 10-day bismuth quadruple therapy as the first line treatment for H. pylori infection.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 352 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of 7-day Proton Pump Inhibitor (PPI)-Clarithromycin Containing Triple Therapy and 10-day Bismuth Quadruple Therapy for Helicobacter Eradication as First-line Regimen: Randomized Controlled Trial
Actual Study Start Date : September 2015
Actual Primary Completion Date : December 2018
Actual Study Completion Date : September 28, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Standard triple therapy
7 day-PPI based standard triple therapy
Drug: Standard triple therapy
Lansoprazole 30mg, 2 times a day + Clarithromycin 500mg, 2 times a day + Amoxicillin 1000mg, 2 times a day for 7 days
Other Name: 7-day PPI-based standard triple therapy

Active Comparator: Bismuth quadruple therapy
10 day-bismuth quadruple therapy
Drug: Bismuth quadruple therapy
Lansoprazole 30mg, 2 times a day + Bismuth 300mg, 4 times a day + Tetracycline 500mg, 4 times a day + Metronidazole 500mg, 3 times a day for 10 days
Other Name: 10-day Bismuth quadruple therapy




Primary Outcome Measures :
  1. H. pylori eradication rate [ Time Frame: 8 weeks after H. pylori treatment ]

Secondary Outcome Measures :
  1. Complications of H. pylori treatment [ Time Frame: 1 month after H. pylori treatment ]
  2. Compliance to H. pylori treatment [ Time Frame: 1 month ]
  3. H. pylori infection status at 1 year after H. pylori treatment [ Time Frame: 1 year after H. pylori treatment ]
  4. H. pylori reinfection rate [ Time Frame: 3 years after success of H. pylori eradication ]
  5. Factors associated with H. pylori reinfection [ Time Frame: 3 years after success of H. pylori treatment ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Men and women aged 18 or more including following conditions

    • Family history of gastric cancer
    • Post endoscopic resection status for early gastric cancer or adenoma
    • Peptic ulcer disease (benign gastric ulcer and duodenal ulcer)
    • Chronic gastritis
    • Non-ulcer dyspepsia
    • Healthy adults who want to receive H. pylori treatment
  • H. pylori positive by urea breath test, histology, or rapid urease test

Exclusion Criteria:

  • History of H. pylori eradication therapy
  • History of stomach operation
  • Other organ cancer within 5 years
  • Liver cirrhosis or Hepatic insufficiency
  • Renal insufficiency
  • Current treatment for serious medical condition which may hinder participation
  • Contraindication or allergy history for H. pylori treatment regimens
  • Mental incompetence to understand and sign informed consent
  • Incompatible conditions to be included into the trial by investigators' decision
  • Inability to provide an informed consent
  • History of treatment for peptic ulcer disease

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): NCT02557932


Locations
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Korea, Republic of
National Cancer Center
Goyang, Gyeonggi-do, Korea, Republic of, 10408
Sponsors and Collaborators
National Cancer Center, Korea
Investigators
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Principal Investigator: Il Ju Choi, M.D., Ph.D. National Cancer Center, Korea
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Responsible Party: Il Ju Choi, Department of gastroenterology, Center for Gastric Cancer, National Cancer Center, Korea
ClinicalTrials.gov Identifier: NCT02557932    
Other Study ID Numbers: NCC2015-0207
First Posted: September 23, 2015    Key Record Dates
Last Update Posted: April 8, 2020
Last Verified: April 2020
Keywords provided by Il Ju Choi, National Cancer Center, Korea:
PPI standard triple therapy
Bismuth quadruple therapy
Helicobacter
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Bismuth
Antacids
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents