Ignite Creation Date:
2024-05-05 @ 6:56 PM
Last Modification Date:
2024-10-26 @ 9:38 AM
Study NCT ID:
NCT00574925
Status:
COMPLETED
Last Update Posted:
2007-12-18
First Post:
2007-12-13
Brief Title:
Study to Assess Management Strategies for the Use of Esomeprazole Nexium in Helicobacter Pylori Infected Patients
Sponsor:
University of Zurich
Organization:
University of Zurich
Study Overview
Official Title:
Randomized Double-Blind Placebo-Controlled Multicenter Study to Assess Management Strategies for the Use of Esomeprazole Nexium in Helicobacter Pylori Infected Patients With Gastroesophageal Reflux Disease GERD
Status:
COMPLETED
Status Verified Date:
2007-12
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 primary objective of this study is to investigate whether eradication treatment of Helicobacter pylori followed by therapy with esomeprazole for a total of 8 weeks extends the time to relapse in patients with gastroesophageal reflux disease GERD
A relapse is defined by two consecutive symptom scores of the Eraflux questionnaire within 14 days that are equal or above the critical value of 25
The secondary objectives are
1 To compare the time to relapse in the two H pylori positive study groups with the H pylori negative control group
2 To compare the pattern of inflammation and atrophy in the two H pylori positive treatment groups with the naturally H pylori negative control group at relapse
3 All the above objectives analyzed for the efficacy subset that is the per-protocol patients broken down by effective H pylori-eradication
Secondary endpoints will be analyzed by the following parameters and their interactions
1 Treatment Eradicated Non-eradicated Hp-negative control
2 Esophagitis at study start grades 0 AB and CD
3 Gender
4 Alcohol intake
5 NSAIDASA intake for histological results
Trial with medicinal product
A relapse is defined by two consecutive symptom scores of the Eraflux questionnaire within 14 days that are equal or above the critical value of 25
The secondary objectives are
1 To compare the time to relapse in the two H pylori positive study groups with the H pylori negative control group
2 To compare the pattern of inflammation and atrophy in the two H pylori positive treatment groups with the naturally H pylori negative control group at relapse
3 All the above objectives analyzed for the efficacy subset that is the per-protocol patients broken down by effective H pylori-eradication
Secondary endpoints will be analyzed by the following parameters and their interactions
1 Treatment Eradicated Non-eradicated Hp-negative control
2 Esophagitis at study start grades 0 AB and CD
3 Gender
4 Alcohol intake
5 NSAIDASA intake for histological results
Trial with medicinal product
Detailed Description:
None
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