Status:
COMPLETED
Comparison of Sequential or Concomitant Therapy for Helicobacter Pylori Infection
Lead Sponsor:
Kaohsiung Veterans General Hospital.
Collaborating Sponsors:
Baylor College of Medicine
Conditions:
Helicobacter Infection
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief 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 ...
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. Ea...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
232 Patients enrolled
Trial Details
Trial ID
NCT00656968
Start Date
May 1 2007
End Date
June 1 2010
Last Update
September 30 2015
Active Locations (2)
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1
Chung-Ho Hospital
Kaohsiung, Taiwan, Taiwan, 807
2
Kaohsiung Veterans General Hospital
Kaohsiung City, Taiwan, 813