Status:
COMPLETED
ADX10059 as an add-on Therapy to Proton Pump Inhibitors (PPIs) in Patients With Gastroesophageal Reflux (GERD)
Lead Sponsor:
Addex Pharma S.A.
Conditions:
Gastroesophageal Reflux
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
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
Eligibility Criteria
Inclusion
- diagnosis of typical GERD
- partial responder to a stable standard clinical symptoms control dose of PPI therapy
- body mass index ≤ 32 kg/m2
Exclusion
- 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
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
298 Patients enrolled
Trial Details
Trial ID
NCT00810485
Start Date
December 1 2008
Last Update
July 16 2012
Active Locations (40)
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1
Little Rock, Arizona, United States
2
Tucson, Arizona, United States
3
Anaheim, California, United States
4
San Diego, California, United States