Status:
COMPLETED
Study of the Safety and Effectiveness of Rabeprazole in Treatment of Helicobacter Pylori Infection in Adults.
Lead Sponsor:
Janssen Cilag Pharmaceutica S.A.C.I., Greece
Conditions:
Helicobacter Infections
Bacterial Infections
Eligibility:
All Genders
18-60 years
Phase:
PHASE4
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 reco...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2006
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00216450
Start Date
October 1 2004
End Date
February 1 2006
Last Update
April 26 2010
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