Validation of Patient-reported outcomes measures for the assessment of Gastroesophageal Reflux Disease (GERD) symptoms - C27
Study identifier:D9120C00027
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
Validation of patient-reported outcomes measures for the assessment of GERD symptoms and their subsequent impact on patients with partial response to Proton Pump Inhibitor (PPI) treatment in a two part multi-center phase IIa study including a four week randomised, double-blind, placebo-controlled, parallel-group treatment period
Medical condition
GERD
Phase
Phase 2
Healthy volunteers
No
Study drug
AZD3355, Placebo, Gelusil®
Sex
All
Actual Enrollment
478
Study type
Interventional
Age
18 Years - 70 Years
Date
Study Start Date: 01 May 2008
Primary Completion Date: 01 Jan 2009
Study Completion Date: 01 Jan 2009
Study design
Allocation: Randomized
Endpoint Classification: N/A
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Other
Verification:
Verified 01 Dec 2014 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: AZD3355 | Drug: AZD3355 Immediate Release capsule administered as a single dose, 65mg, twice daily for 4 weeks Other Name: Lesogaberan Drug: Gelusil® Chewable tablets taken as needed Other Name: Gelusil® |
| Placebo Comparator: Placebo | Drug: Placebo capsule. administered as a single dose twice daily for 4 weeks Drug: Gelusil® Chewable tablets taken as needed Other Name: Gelusil® |
Contacts
Investigators
Principal Investigator
Debra Silberg
AstraZeneca
