Study of the Safety and Effectiveness of Rabeprazole in Treatment of Helicobacter Pylori Infection in Adults.

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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An Open Observational Study For The Rabeprazole Administration In Adult Subjects With Helicobacter Pylori (H. Pylori) Infection

Conditions
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Helicobacter Infections, Bacterial Infections

Intervention / Treatment
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* Drug: rabeprazole sodium


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: rabeprazole sodium|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events throughout the study |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Laboratory tests (hematology, biochemistry, urinalysis) and vital signs at start of study and one month after treatment; eradication of H. pylori infection, assessed by urea breath test one month after treatment |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rabeprazole, proton pump inhibitor, Helicobacter infections, Helicobacter pylori, H pylori, bacterial infections