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

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ClinicalTrials.gov Identifier: NCT00216450
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : April 26, 2010
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Helicobacter Infections Bacterial Infections Drug: rabeprazole sodium Phase 4

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Observational Study For The Rabeprazole Administration In Adult Subjects With Helicobacter Pylori (H. Pylori) Infection
Study Start Date : October 2004
Actual Study Completion Date : February 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Incidence of adverse events throughout the study

Secondary Outcome Measures :
  1. 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


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00216450


Sponsors and Collaborators
Janssen Cilag Pharmaceutica S.A.C.I., Greece
Investigators
Study Director: Janssen-Cilag Pharmaceutica S.A.C.I. Clinical Trial Janssen-Cilag Pharmaceutica S.A.C.I.

ClinicalTrials.gov Identifier: NCT00216450     History of Changes
Other Study ID Numbers: CR003478
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: April 26, 2010
Last Verified: April 2010

Keywords provided by Janssen Cilag Pharmaceutica S.A.C.I., Greece:
rabeprazole
proton pump inhibitor
Helicobacter infections
Helicobacter pylori
H pylori
bacterial infections

Additional relevant MeSH terms:
Bacterial Infections
Gram-Negative Bacterial Infections
Infection
Communicable Diseases
Helicobacter Infections
Rabeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action