A Multicenter, Randomized, Double-Blind, Placebo-Controlled Efficacy Study Comparing 4 Weeks of Treatment with Esomeprazole 20 mg qd and 40 mg qd to Placebo qd in Patients with Heartburn and Sleep Disturbances Associated with Gastroesophageal Reflux Disease (GERD)
Study identifier:D961AC00001
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Efficacy Study Comparing 4 Weeks of Treatment with Esomeprazole 20 mg qd and 40 mg qd to Placebo qd in Patients with Heartburn and Sleep Disturbances Associated with Gastroesophageal Reflux Disease (GERD)
Medical condition
Gastroesophageal reflux disease (GERD)
Phase
Phase 4
Healthy volunteers
No
Study drug
Esomeprazole, Placebo
Sex
All
Actual Enrollment
600
Study type
Interventional
Age
18 Years - 85 Years
Date
Study Start Date: 01 Apr 2003
Primary Completion Date: 01 Aug 2003
Study Completion Date: 01 Aug 2003
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 | Drug: Esomeprazole 20mg Oral tablet once daily Other Name: Nexium |
| Experimental: 2 | Drug: Esomeprazole 40mg Oral tablet once daily Other Name: Nexium |
| Placebo Comparator: 3 | Drug: Placebo Oral once daily |
Contacts
Investigators
Principal Investigator
Paula Fernstrom
Nexium Global Product Director, AstraZeneca
