At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 478 enrolled
Drug / intervention
AZD3355 +2 moredrug
Likely dose
AZD3355 65mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating AZD3355, Placebo, and 1 other intervention for GERD and 3 related conditions. Completed, enrolled 478 participants across 84 sites.
Detailed Summary
This research study is being done to gather information about how to do further clinical studies using AZD3355 as an add-on treatment to proton pump inhibitors (PPI).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGERD, Acid Reflux Disease, Heartburn, Regurgitation
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMay 2008
First PostedJun 2008
Primary CompletionJan 2009
TodayJul 2026
First PostedJun 23, 2008
Enrollment StartMay 1, 2008
Primary CompletionJan 1, 2009
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 18.0 years ago
Interventions
AZD3355drug
Immediate Release capsule administered as a single dose, 65mg, twice daily for 4 weeks
Placebodrug
capsule. administered as a single dose twice daily for 4 weeks
Gelusil®drug
Chewable tablets taken as needed