ADX10059 as an add-on Therapy to Proton Pump Inhibitors (PPIs) in Patients With Gastroesophageal Reflux (GERD)

A Phase 2B, Randomised, Double-blind, Placebo-controlled, Parallel Group, Dose-ranging, Multi-centre Study to Investigate the Efficacy, Safety and Tolerability of the mGluR5 Negative Allosteric Modulator ADX10059 in Patients With Gastroesophageal Reflux Disease (GERD) Who Are Partial Responders to Proton Pump Inhibitor (PPI) Treatment

The purpose of this study is to evaluate the effect of ADX10059 in patients with gastroesophageal reflux disease who are partial responders to proton pump inhibitors

Inclusion Criteria:

• diagnosis of typical GERD
• partial responder to a stable standard clinical symptoms control dose of PPI therapy
• body mass index ≤ 32 kg/m2

Exclusion Criteria:

• exclusively atypical symptoms of GERD
• symptoms that have been shown not to be associated with GERD
• erosive oesophagitis
• treated with a dose of PPI greater than the dose indicated for clinical symptom control of GERD
• hiatus hernia > 3 cm
• current diagnosis of co-existing psychiatric disease
• known clinical significant allergy or known hypersensitivity to drugs
• is pregnant or breast-feeding
• has received sodium valproate or topiramate within 30 days of Screening
• has a history of a significant medical condition that may affect the safety of the patient or preclude adequate participation in the study