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Phase IV Study Comparing the Duration of Sequential Therapy


Phase 4
20 Years
N/A
Not Enrolling
Both
H. Pylori Infection

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Trial Information

Phase IV Study Comparing the Duration of Sequential Therapy


Inclusion Criteria:



1. Patients are aged greater than 20 years who have H. pylori infection without prior
eradication therapy and are willing to receive the sequential therapy will be eligible for
enrollment.

Exclusion Criteria:

1. children and teenagers aged less than 20 years,

2. history of gastrectomy,

3. gastric malignancy, including adenocarcinoma and lymphoma,

4. previous allergic reaction to antibiotics (amoxicillin, clarithromycin, levofloxacin,
metronidazole) and prompt pump inhibitors (lansoprazole),

5. contraindication to treatment drugs,

6. pregnant or lactating women,

7. severe concurrent disease,

8. Patients who cannot give informed consent by himself or herself.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Eradication rate according to Intention to treat (ITT) and per-protocol (PP) analysis

Outcome Time Frame:

6 weeks after eradication therapy

Safety Issue:

No

Principal Investigator

Jyh-Ming Liou, M.D

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Taiwan University Hospital

Authority:

Taiwan: Department of Health

Study ID:

200909054M

NCT ID:

NCT01042184

Start Date:

December 2009

Completion Date:

March 2012

Related Keywords:

  • H. Pylori Infection
  • H. pylori infected patients without prior eradication therapy
  • Helicobacter Infections

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