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

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Gastroesophageal Reflux

Intervention / Treatment
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* Drug: ADX10059
* Drug: ADX10059
* Drug: ADX10059
* Drug: ADX10059 Matching Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ADX10059 50 mg<br>twice-daily | Drug: ADX10059<br>* oral administration<br>|
| Experimental: ADX10059 100 mg<br>twice-daily | Drug: ADX10059<br>* oral administration<br>|
| Experimental: ADX10059 150 mg<br>twice-daily | Drug: ADX10059<br>* oral administration<br>|
| Placebo Comparator: ADX10059 Matching Placebo<br>twice-daily | Drug: ADX10059 Matching Placebo<br>* oral administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of GERD symptom free days in week 4 of study medication treatment |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GERD symptoms |  | 4 weeks | 
| Sleep disturbance |  | 4 weeks | 
| Use of antacid medications |  | 4 weeks | 
| Global assessment of GERD |  | 4 weeks | 
| Safety and tolerability assessments |  | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastroesophageal reflux, Proton pump inhibitor, Heartburn, Regurgitation