ADX10059 as a Monotherapy in Patients With Gastroesophageal Reflux (GERD)

A Phase 2B, Randomised, Double-blind, Placebo-controlled, Parallel Group, Multi-centre Study to Investigate the Efficacy, Mechanism of Action, Pharmacokinetics, Safety and Tolerability of the mGluR5 Negative Allosteric Modulator ADX10059 as Monotherapy in Patients With Gastroesophageal Reflux Disease (GERD)

Evaluation of the effect of ADX10059 on symptom control in patients with gastroesophageal reflux.

Inclusion Criteria:

• diagnosis of typical GERD
• well controlled on a standard clinical symptoms controlled dose of PPI treatment
• 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
• hiatus hernia > 3 cm
• current diagnosis of co-existing psychiatric disease
• known clinically significant allergy or known hypersensitivity to drugs
• 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