NCT01043185

A Study to Estimate Effect of 4 Different Doses of AZD3355 on Reflux Episodes, Which Patients With Gastroesophageal Reflux Disease (GERD) May Experience

A Double-blind, Placebo Controlled, Randomised, Phase IIA Pharmacodynamic 4-way Cross-over Study to Estimate the Dose Response Relationship of AZD3355 on the Number of Reflux Episodes Assessed by Impedance/pH in Patients With GERD and a Partial Response to PPI Treatment

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to estimate what effect 4 different doses of AZD3355 will have on the number of reflux episodes, in patients who have GERD and still experience symptoms despite proton pump inhibitor (PPI) treatment.

Conditions

• Gastroesophageal Reflux Disease

Interventions

Type	Name	Description
DRUG	AZD3355	30 mg orally in the morning and 30 mg in the evening for 1 day
DRUG	AZD3355	90 mg orally in the morning and 90 mg in the evening for 1 day
DRUG	AZD3355	120 mg orally in the morning and 120 mg in the evening for 1 day
DRUG	AZD3355	240 mg orally in the morning and 240 mg in the evening for 1 day
DRUG	placebo	Placebo capsules orally in the morning and placebo capsules in the evening for 1 day

Timeline

• Start date: 2009-12-01
• Primary completion: 2010-05-01
• Completion: 2010-05-01
• First posted: 2010-01-06
• Last updated: 2011-06-14
• Results posted: 2011-06-14

Locations

1 site across 1 country: United States