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
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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Number of Participants in Which H. Pylori Was Eradicated
Evaluate eradication outcome by endoscopy urease test and histology or urea breath test
one month after finishing study drugs
Ching-Kuan Liu, MD, PhD
Kaohsiung Medical Univestity
Taiwan: Institutional Review Board