TLESR-impedance Study in Patients

A Double-blind, Placebo Controlled, Randomized, Two Centre Phase IIA Pharmacodynamic Cross-over Study to Assess the Effect of AZD3355, 65 mg Bid, on Transient Lower Esophageal Sphincter Relaxations (TLESRs) in GERD Patients With an Incomplete Response to PPI Treatment

The purpose of the study is to compare frequency and content of reflux episodes in patients with gastroesophageal reflux disease.

Inclusion Criteria:

• Provision of written consent
• GERD patients, age 18-70 years, females must be postmenopausal or surgically sterilised
• 6 months history of GERD and incomplete response to PPI treatment

Exclusion Criteria:

• Insufficient symptom burden of the reflux disease evaluated by questionnaires
• S-creatinine >1.2 times upper limit of normal
• History of heart disease
• Prior surgery of the upper GI tract