A Multicenter, Randomized, Double-Blind Parallel-Group, Placebo-Controlled Efficacy Study Comparing 4 Weeks of Treatment with Esomeprazole 20 mg once daily to Placebo qd for the Resolution of Upper Abdominal Pain in Patients with Symptomatic Gastroesophageal Reflux Disease (sGERD)
Study identifier:D9619C00001
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Multicenter, Randomized, Double-Blind Parallel-Group, Placebo-Controlled Efficacy Study Comparing 4 Weeks of Treatment with Esomeprazole 20 mg once daily to Placebo qd for the Resolution of Upper Abdominal Pain in Patients with Symptomatic Gastroesophageal Reflux Disease (sGERD)
Medical condition
Symptomatic Gastroesophageal Reflux Disease (sGERD)
Phase
Phase 3
Healthy volunteers
No
Study drug
Esomeprazole, Matching placebo
Sex
All
Actual Enrollment
500
Study type
Interventional
Age
18 Years - 75 Years
Date
Study Start Date: 01 Mar 2003
Primary Completion Date: 01 Feb 2004
Study Completion Date: 01 Feb 2004
Study design
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Nov 2013 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
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| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 20mg once daily | Drug: Esomeprazole 20mg Oral Once Daily Other Name: Nexium |
| Placebo Comparator: 2 Oral once daily | Drug: Matching placebo Oral Once Daily |
Contacts
Investigators
Principal Investigator
Paula Fernstrom
Nexium Global Product Director, AstraZeneca
