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

Bacterial Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00216450
• Other study ID #: CR003478
• Status: Completed
• Phase: Phase 4
• First received: September 13, 2005
• Last updated: April 22, 2010
• Start date: October 2004
• Est. completion date: February 2006

Study information

• Verified date: April 2010
• Source: Janssen Cilag Pharmaceutica S.A.C.I., Greece
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: Hellenic Republic Ministry Of Health And Welfare National Organization For Medicines
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: February 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bacterial Infections
• Communicable Diseases
• Helicobacter Infections
• Infection

Intervention

Drug:
• rabeprazole sodium

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Cilag Pharmaceutica S.A.C.I., Greece

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events throughout the study
Secondary	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