Comparison of Sequential or Concomitant Therapy for Helicobacter Pylori Infection

• Status: Completed
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kaohsiung Veterans General Hospital.
• Collaborator: Baylor College of Medicine
• Treatments: Amoxicillin; Clarithromycin; Esomeprazole; Metronidazole

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.