NCT01005251

Investigate the Effect of Different Doses of Lesogaberan (AZD3355) as add-on to PPI in GERD Patients With Partial Response to PPI

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 661 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study is being carried out to see whether AZD3355 is an effective treatment as an add-on to PPI therapy in patients with Gastroesophageal Reflux Disease (GERD) with a partial response to PPI and to compare this with Proton Pump Inhibitor (PPI) treatment alone. Another goal of the study is to examine which of the investigated doses of AZD3355 is optimal for treatment of these patients. This study will also measure levels of drug in the blood and see how well it is tolerated.

Conditions

• Gastroesophageal Reflux Disease
• Heartburn
• Regurgitation

Interventions

Type	Name	Description
DRUG	lesogaberan (AZD3355)	60 mg, oral, capsules, bid for 4 w
DRUG	lesogaberan (AZD3355)	120 mg, oral, capsules, bid for 4 w
DRUG	lesogaberan (AZD3355)	180 mg, oral, capsules, bid for 4 w
DRUG	lesogaberan (AZD3355)	240 mg, oral, capsules, bid for 4 w
DRUG	Placebo	oral,capsules, bid for 4 w

Timeline

• Start date: 2009-10-01
• Primary completion: 2010-07-01
• Completion: 2010-07-01
• First posted: 2009-10-30
• Last updated: 2011-04-25
• Results posted: 2011-04-25

Locations

1 site across 1 country: United States