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

Condition(s) targeted: Bacterial Infections; Helicobacter Infections

Intervention: rabeprazole sodium (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Janssen Cilag Pharmaceutica S.A.C.I., Greece

Official(s) and/or principal investigator(s):
Janssen-Cilag Pharmaceutica S.A.C.I. Clinical Trial, Study Director, Affiliation: Janssen Cilag Pharmaceutica S.A.C.I., Greece

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.

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

Study design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study

Primary outcome: Incidence of adverse events throughout the study

Secondary outcome: 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

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.

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.

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

Starting date: October 2004
Ending date: February 2006
Last updated: March 17, 2008