Comparison of Sequential or Concomitant Therapy for Helicobacter Pylori Infection
Condition: Helicobacter Infection
MeSH terms: Infections; Communicable Diseases; Helicobacter Infections
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      The purpose of this study is to compare different methods of giving combination drug therapy
      for treating Helicobacter pylori infection of the stomach. The entire study will last less
      than 2 years. Each subject will be participating in the study for approximately 60 days.

      A total of 360 subjects will be asked to participate in this study.

      Before participating in this study, subject's must have undergone to confirm the presence and
      to assess the susceptibility of Helicobacter pylori. Qualified subjects will receive 4 drugs
      which are to be taken as part of the study treatment: an acid suppressing drug (name),
      amoxicillin, clarithromycin and metronidazole. The doses are 1 grams of amoxicillin, 40 mg of
      esomeprazole (Nexium), 500 mg of metronidazole and 250 mg of clarithromycin. Each drug will
      be given twice a day to be taken twice a day with the morning and evening meals. Subjects
      will receive one of three different combinations. The choice of which will be randomly chosen
      by the use of a computer program. The regimes are: all 4 drugs daily for 5 days, all 4 drugs
      daily for 10 days, and two drugs (esomeprazole and amoxicillin) for 5 days then all for drugs
      for 5 additional days.

      Subjects will be asked to return within 4 days after completion of the treatment to evaluate
      how they did with the drugs. They will be asked bring back all unused medication and the
      bottles or containers that the medicine was packaged in. Your medication use and tolerance to
      the study drugs will be assessed. The treatment portion of the study will be complete at this
      point.

      Evaluation of the effect of the treatment will take place 4-6 weeks after the end of therapy.
      Subjects will come back to the study site and will have a UBT or repeat endoscopy, if
      clinically indicated to verify that the Helicobacter pylori has been cured. Subjects will be
      asked not to take antibiotics or any other drugs that may affect the outcome of the breath
      test used to confirm that the treatment was successful.
    

Intervention name(s): 10-day sequential treatment; 10-day concomitant therapy
Intervention type(s): Drug; Drug
Intervention description(s): 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
Other intervention name(s): Nexium-based sequential therapy; Nexium-based quadruple therapy
Intervention MeSH terms: Esomeprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: peptic ulcer disease; gastric cancer; therapeutics