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

Phase 4

Completed

• Conditions: Helicobacter Infections; Bacterial Infections

• Registration Number: NCT00216450
• Lead Sponsor: Janssen Cilag Pharmaceutica S.A.C.I., Greece

Brief Summary

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

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.

Study Timeline

• Study Start: 2004-10
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-22
• Study Completion: 2006-02
• Status Verified: 2010-04
• Last Update Submitted: 2010-04-22
• Last Update Posted: 2010-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Incidence of adverse events throughout the study

Secondary Outcome Measures

Name	Time	Method
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