Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00216450
Status:
COMPLETED
Last Update Posted:
2010-04-26
First Post:
2005-09-13
Brief Title:
Study of the Safety and Effectiveness of Rabeprazole in Treatment of Helicobacter Pylori Infection in Adults
Sponsor:
Janssen Cilag Pharmaceutica SACI Greece
Organization:
Janssen Cilag Pharmaceutica SACI Greece
Study Overview
Official Title:
An Open Observational Study For The Rabeprazole Administration In Adult Subjects With Helicobacter Pylori H Pylori Infection
Status:
COMPLETED
Status Verified Date:
2010-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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 milligramsmg taken orally twice daily for 7 days Clarithromycin 500mg and amoxycillin 1 gram taken twice daily for 7 days
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None