NCT00216450

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Oct 2004

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2006

Completed
Last Updated

April 26, 2010

Status Verified

April 1, 2010

First QC Date

September 13, 2005

Last Update Submit

April 22, 2010

Conditions

Helicobacter InfectionsBacterial Infections

Keywords

rabeprazoleproton pump inhibitorHelicobacter infectionsHelicobacter pyloriH pyloribacterial infections

Outcome Measures

Primary Outcomes (1)

  • Incidence of adverse events throughout the study

Secondary Outcomes (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

Interventions

rabeprazole sodiumDRUG

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Helicobacter InfectionsBacterial Infections

Interventions

Rabeprazole

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial InfectionsBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Janssen-Cilag Pharmaceutica S.A.C.I. Clinical Trial

    Janssen-Cilag Pharmaceutica S.A.C.I.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 22, 2005

Study Start

October 1, 2004

Study Completion

February 1, 2006

Last Updated

April 26, 2010

Record last verified: 2010-04