Sequential Versus Concomitant Therapy for Helicobacter Pylori Infection
18 Years
75 Years
Both
Helicobacter Infection
Trial Information
Sequential Versus Concomitant Therapy for Helicobacter Pylori Infection
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.
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Outcome Measure:
Number of Participants in Which H. Pylori Was Eradicated
Outcome Description:
Evaluate eradication outcome by endoscopy urease test and histology or urea breath test
Outcome Time Frame:
one month after finishing study drugs
Safety Issue:
No
Principal Investigator
Ching-Kuan Liu, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
Kaohsiung Medical Univestity
Authority:
Taiwan: Institutional Review Board
Study ID:
KMU-IRB00003151
NCT ID:
NCT00656968
Start Date:
May 2007
Completion Date:
June 2010
Related Keywords:
- Helicobacter Infection
- peptic ulcer disease
- gastric cancer
- therapeutics
- Helicobacter Infections
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