Nexium (esomeprazole) in Symptom adapted therapy in GERD Patients - MAESTRO
Study identifier:D9612L00111
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A randomized, open, parallel-group study to evaluate the efficacy of three different patient management strategies during a 12 weeks maintenance phase following an initial 4-weeks acute treatment phase in subjects with symptoms thought to be GERD related
Medical condition
GERD
Phase
Phase 4
Healthy volunteers
No
Study drug
esomeprazole (Nexium®), Xolaam®
Sex
All
Actual Enrollment
3029
Study type
Interventional
Age
18 Years - 50 Years
Date
Study Start Date: 01 Mar 2007
Primary Completion Date: 01 Oct 2008
Study Completion Date: 01 Oct 2008
Study design
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Verification:
Verified 01 Nov 2012 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
Loading...
No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: Esomeprazole 20 mg Once Daily (initial phase) | Drug: esomeprazole (Nexium®) This randomized study was conducted on parallel groups and included two phases: - One initial phase during when the patients received once daily, either esomeprazole 20 mg or esomeprazole 40 mg, depending on the investigator’s decision - One maintenance treatment phase, patients were randomized to one of the following three groups, either esomeprazole 20 mg once daily, or esomeprazole 20 mg on demand or antacid treatment as needed |
| Experimental: Esomeprazole 40 mg Once Daily (initial phase) | Drug: esomeprazole (Nexium®) This randomized study was conducted on parallel groups and included two phases: - One initial phase during when the patients received once daily, either esomeprazole 20 mg or esomeprazole 40 mg, depending on the investigator’s decision - One maintenance treatment phase, patients were randomized to one of the following three groups, either esomeprazole 20 mg once daily, or esomeprazole 20 mg on demand or antacid treatment as needed |
| Experimental: Esomeprazole 20 mg Once Daily (Maintenance Phase) | Drug: esomeprazole (Nexium®) This randomized study was conducted on parallel groups and included two phases: - One initial phase during when the patients received once daily, either esomeprazole 20 mg or esomeprazole 40 mg, depending on the investigator’s decision - One maintenance treatment phase, patients were randomized to one of the following three groups, either esomeprazole 20 mg once daily, or esomeprazole 20 mg on demand or antacid treatment as needed |
| Experimental: Esomeprazole 20 mg on Demand (Maintenance Phase) | Drug: esomeprazole (Nexium®) This randomized study was conducted on parallel groups and included two phases: - One initial phase during when the patients received once daily, either esomeprazole 20 mg or esomeprazole 40 mg, depending on the investigator’s decision - One maintenance treatment phase, patients were randomized to one of the following three groups, either esomeprazole 20 mg once daily, or esomeprazole 20 mg on demand or antacid treatment as needed |
| Experimental: Antacid Treatment (Maintenance Phase) | Drug: Xolaam® This randomized study was conducted on parallel groups and included two phases: - One initial phase during when the patients received once daily, either esomeprazole 20 mg or esomeprazole 40 mg, depending on the investigator’s decision - One maintenance treatment phase, patients were randomized to one of the following three groups, either esomeprazole 20 mg once daily, or esomeprazole 20 mg on demand or antacid treatment as needed |
Contacts
Investigators
Principal Investigator
AstraZeneca France Medical Director
AstraZeneca
