Gastroesophageal Reflux
Conditions
Keywords
Gastroesophageal reflux, Heartburn, Regurgitation
Brief summary
Evaluation of the effect of ADX10059 on symptom control in patients with gastroesophageal reflux.
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 * 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of GERD symptom free days in week 2 of study medication treatment | 2 weeks |
Secondary
| Measure | Time frame |
|---|---|
| GERD symptoms | 2 weeks |
| Sleep disturbance | 2 weeks |
| Use of antacid rescue medication | 2 weeks |
| Global assessment of GERD | 2 weeks |
| Effect on lower oesophageal sphincter and reflux episodes | 2 weeks |
Countries
Austria, Belgium, France, Germany
Outcome results
None listed