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

• Status: Completed
• Trial end date: 2006-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Cilag Pharmaceutica S.A.C.I., Greece
• Treatments: Rabeprazole

Criteria

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