Study of the Safety and Effectiveness of Rabeprazole in Treatment of Helicobacter Pylori Infection in Adults.
Study of the Safety and Effectiveness of Rabeprazole in Treatment of Helicobacter Pylori Infection in Adults.
The purpose of the study is to confirm the safety and effectiveness of rabeprazole in the
 treatment of adult patients with Helicobacter pylori (H. pylori) infection in routine
 clinical practice.
An infection of Helicobacter pylori (H. pylori) is a risk factor for many types of
 gastrointestinal diseases and associated with stomach inflammation, ulcer of the stomach or
 small intestine. The recommended treatment for the infection is a triple therapy consisted of
 one proton pump inhibitor, such as rabeprazole, and two antibiotics administered for 7 days.
 This is an open label, nonrandomized study of the safety of rabeprazole in the treatment of
 patients with H. pylori infection. The study consists of 2 phases: the 2-month main phase and
 the 4-month monitoring phase (total duration of 6 months). During the main phase, patients
 are treated for 7 days with three drugs (rabeprazole, clarithromycin, and amoxycillin), and
 the effectiveness of the treatment is assessed 4 weeks later. During the monitoring phase,
 patients are interviewed at monthly intervals to assess symptoms and to report any adverse
 events. Safety assessments include the incidence of adverse events throughout the treatment
 and monitoring phases, and laboratory tests (hematology, biochemistry, urinalysis) and vital
 signs at the start of the study and after 1 month. Assessments of effectiveness include the
 eradication of H. pylori infection, assessed by the urea breath test one month after
 treatment. The primary study hypothesis is that rabeprazole is well-tolerated long-term in
 the treatment of patients with H. pylori infection in routine clinical practice. Rabeprazole
 tablets (20 milligrams[mg]) taken orally twice daily for 7 days. Clarithromycin (500mg) and
 amoxycillin (1 gram) taken twice daily for 7 days.
Inclusion Criteria:

 -  Patients diagnosed with Helicobacter pylori (H. pylori) infection

 -  patients over 45 years of age must have an endoscopic examination of the digestive
 system

 -  patients must have positive result of urea breath test (UBT) for H. pylori

 -  patients being treated with rabeprazole in combination with clarithromycin and
 amoxycillin to eradicate H. pylori.

 Exclusion Criteria:

 -  Known hypersensitivity to rabeprazole, clarithromycin, or amoxycillin

 -  evidence from endoscopic examination of gastrointestinal hemorrhage or stomach cancer,
 or had previous stomach surgery

 -  use of aspirin, non-steroidal anti-inflammatory drugs (NSAIDs), antibiotics, bismuth,
 or proton pump inhibitors during the last 4 weeks prior to study initiation

 -  history of successful treatment to eradicate H.pylori infection

 -  females who are pregnant or nursing