Gastroesophageal Reflux
Conditions
Keywords
Gastroesophageal reflux, Proton pump inhibitor, Heartburn, Regurgitation
Brief summary
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
Interventions
DRUGADX10059
oral administration
oral administration
Sponsors
Addex Pharma S.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of GERD symptom free days in week 4 of study medication treatment | 4 weeks |
Secondary
| Measure | 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 |
Countries
France, Germany, Netherlands, Switzerland, United States
Outcome results
None listed