Investigate the effect of different doses of lesogaberan (AZD3355) as add-on to PPI in GERD patients with partial response to PPI
Study identifier:D9120C00019
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
-
Medical condition
Gastroesophageal Reflux Disease, Acid Reflux
Phase
Phase 2
Healthy volunteers
No
Study drug
lesogaberan (AZD3355), Placebo
Sex
All
Actual Enrollment
661
Study type
Interventional
Age
18 Years - 70 Years
Date
Study Start Date: 01 Oct 2009
Primary Completion Date: 01 Jul 2010
Study Completion Date: 01 Jul 2010
Study design
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Mar 2011 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: 60 mg PPI+lesogaberan (AZD3355) 60 mg bid | Drug: lesogaberan (AZD3355) 60 mg, oral, capsules, bid for 4 w |
| Experimental: 120 mg PPI+lesogaberan (AZD3355) 120 mg bid | Drug: lesogaberan (AZD3355) 120 mg, oral, capsules, bid for 4 w |
| Experimental: 180 mg PPI+lesogaberan (AZD3355) 180 mg bid | Drug: lesogaberan (AZD3355) 180 mg, oral, capsules, bid for 4 w |
| Experimental: 240 mg PPI+lesogaberan (AZD3355) 240 mg bid | Drug: lesogaberan (AZD3355) 240 mg, oral, capsules, bid for 4 w |
| Placebo Comparator: Placebo PPI+ Placebo | Drug: Placebo oral,capsules, bid for 4 w |
Contacts
Investigators
Principal Investigator
Debra Silberg
AstraZeneca
