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

Completed · Phase 2 · Has a placebo group

Conditions studied: Gastroesophageal Reflux Disease, Heartburn, Regurgitation

In brief

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.

Key facts

Study ID

NCT01005251

Run by

AstraZeneca

People needed

661

Starts

2009-10-01

Expected to finish

2010-07-01

Last updated by the study team

2011-04-25

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Provision of informed consent prior to any study specific procedures
• Have at least 6 months history of GERD
• Continuously treated during the last 4 weeks before enrolment with daily optimized unchanged PPI therapy for any GERD indication

You may not qualify if…

• Patients that have not experienced any GERD symptom improvement at all during PPI treatment
• Prior surgery of the upper gastrointestinal tract.
• Subject who have any of the following conditions or diseases: Heart disease, Angina, Seizure disorders such as epilepsy, Congestive Heart Failure (CHF), Liver disease such as Cirrhosis or Hepatitis, Kidney disease, Lung disease or lung cancer, Cancer

Where it is running

• Research Site — Oklahoma City, Oklahoma, United States

Full record on ClinicalTrials.gov

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