Comparison of Sequential or Concomitant Therapy for Helicobacter Pylori Infection
Condition: Helicobacter Infection
MeSH terms: Infections; Communicable Diseases; Helicobacter Infections
Intervention: 10-day sequential treatment; 10-day concomitant therapy
Intervention description: esomeprazole (40 mg daily) from day 1 to day 10, amoxicillin (1 g, bid) from day 1 to day 5, clarithromycin (500 mg, bid) from day 6 to day 10, metronidazole (500 mg, bid) from day 6 to day 10; esomeprazole (40 mg, bid) from day 1 to day 10, amoxicillin (1 g, bid) from day 1 to day 10, clarithromycin (500 mg, bid) from day 1 to day 10, metronidazole (500 mg, bid) from day 1 to day 10
Intervention MeSH terms: Esomeprazole
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 232.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: peptic ulcer disease; gastric cancer; therapeutics

Summary:

      Helicobacter pylori is a bacteria that infects the lining of the stomach and is associated
      with ulcers. Helicobacter pylori may also increase the long-term risk of developing certain
      forms of gastric cancer. Curing this infection generally requires that patients take 2 or
      more antibiotic medications and a stomach acid suppressing medication for about two weeks.
      Current treatments do not always cure the infection and a new treatment is being tested in
      this study. The drugs involved in the new 4 drug treatment have been widely used for
      treatment of this infection. It remains unknown what is the best and most cost effective way
      to give them. This study will compare three different ways of using these drugs.

      Subjects must have active Helicobacter pylori infection in order to participate in this
      study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or non-pregnant female aged 18 to 75 years inclusively.

          -  Mental and legal ability to give a written informed consent.

          -  Active H. pylori infection.

        Exclusion Criteria:

          -  Previous surgery of the stomach such as partial gastrectomy.

          -  Use of antibiotics within the preceding 30 days.

          -  Regular use of bismuth compounds (>3 times per week) in the 30 days before enrollment.

          -  Presence of serious medical condition(s) precluding participation or endoscopy with
             biopsy.

          -  Use of concomitant medication(s) known to interact with study medication.

          -  Presence of Zollinger-Ellison Syndrome.

          -  Pregnancy or lactation.

          -  Allergy to any of the study medications.

          -  Contraindication(s) to the use of any of the study drugs.

          -  Participation in a clinical trial within the last 30 days.

          -  Unwillingness to abstain from alcoholic beverages.

          -  Patients taking other medications including warfarin, antipsychotics, or chronic
             NSAIDs will also be excluded. Aspirin at a dose not more than 325 mg/day will be
             permitted.