ADX10059 as an add-on Therapy to Proton Pump Inhibitors (PPIs) in Patients With Gastroesophageal Reflux (GERD)
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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
Study Start Date :
Actual Primary Completion Date :
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Ages Eligible for Study:
18 Years to 70 Years (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
diagnosis of typical GERD
partial responder to a stable standard clinical symptoms control dose of PPI therapy
body mass index ≤ 32 kg/m2
exclusively atypical symptoms of GERD
symptoms that have been shown not to be associated with GERD
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