NCT00703534

Validation of Patient-reported Outcomes Measures for the Assessment of Gastroesophageal Reflux Disease (GERD) Symptoms

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 478 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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).

Conditions

• GERD
• Acid Reflux Disease
• Heartburn
• Regurgitation

Interventions

Type	Name	Description
DRUG	AZD3355	Immediate Release capsule administered as a single dose, 65mg, twice daily for 4 weeks
DRUG	Placebo	capsule. administered as a single dose twice daily for 4 weeks
DRUG	Gelusil®	Chewable tablets taken as needed

Timeline

• Start date: 2008-05-01
• Primary completion: 2009-01-01
• Completion: 2009-01-01
• First posted: 2008-06-23
• Last updated: 2011-06-20
• Results posted: 2011-06-20

Locations

84 sites across 1 country: United States