Status:
COMPLETED
ADX10059 as a Monotherapy 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
Evaluation of the effect of ADX10059 on symptom control in patients with gastroesophageal reflux.
Eligibility Criteria
Inclusion
- diagnosis of typical GERD
- well controlled on a standard clinical symptoms controlled dose of PPI treatment
- 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
- 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
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00820079
Start Date
December 1 2008
Last Update
December 24 2009
Active Locations (11)
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1
Wien
Vienna, Austria
2
Leuven
Leuven, Belgium
3
Bordeaux
Bordeaux, France
4
Lyon
Lyon, France