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NCT Number: NCT00841854

Comparison of 7-day and 14-day Bismuth Based Quadruple Therapy for Secondary Helicobacter Pylori Eradication

At present, triple therapy are recommended by various guidelines for the treatment of Helicobacter pylori (H. pylori) infection. Recent studies have shown worldwide high treatment failure rates with one week first line clarithromycin based triple therapy necessitating salvage strategy to eradicate H. pylori in primary treatment failure. However, the exact duration of bismuth based second line treatment is not determined. Therefore, the investigators performed this study to evaluate the eradication rate of 1 or 2-week quadruple regimen as a second-line therapy.

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Key information

Conditions

Helicobacter Infection Bacterial Infections Bacterial Infections and Mycoses Gram-Negative Bacterial Infections Helicobacter Infections Infections

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Asan Medical Center

Seoul, 138-736, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • H. pylori infection
  • Aged between 18-80 years
  • Are willing to received eradication therapy for H. pylori

Exclusion criteria

  • Children and teenagers aged less than 18 years or over 80 years
  • Previous eradication therapy for H. pylori
  • History of gastrectomy
  • Previous allergic reaction to antibiotics
  • Use of prompt pump inhibitors and antibiotics in the recent 4 weeks
  • Active upper GI bleeding in the recent 1 week
  • Contraindication to treatment drugs
  • Pregnant or lactating women
  • Severe concurrent disease or malignancy

Treatment and study plan

Pantoprazole

Drug

pantoprazole 40mg bid

Bismuth

Drug

bismuth 300mg qid

Metronidazole

Drug

metronidazole 500mg tid

Tetracycline

Drug

tetracycline 500mg qid

Primary outcomes

  1. Whether the two week group yield a higher eradication rate comparing to the one week group.

    Time frame: At least four week after completion of treatment

Secondary outcomes

  1. side effect

    Time frame: four weeks after completion of medication

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Collaborators

  • Inje University
  • Pacific Pharmaceuticals

Registry information

Official study title

Comparison of 7-day and 14-day Bismuth Based Quadruple Therapy for Secondary Helicobacter Pylori Eradication.

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Feb 11, 2009
Registry last updated
Dec 6, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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