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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Addex Pharma S.A.
• Treatments: Proton Pump Inhibitors

Criteria

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