ADX10059 as a Monotherapy in Patients With Gastroesophageal Reflux (GERD)
NCT ID: NCT00820079
Last Updated: 2009-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
120 participants
INTERVENTIONAL
2008-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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ADX10059 120 mg
Twice-daily
ADX10059
oral administration
ADX10059 Matching Placebo
twice-daily
ADX10059 Matching Placebo
oral administration
Interventions
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ADX10059
oral administration
ADX10059 Matching Placebo
oral administration
Eligibility Criteria
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Inclusion Criteria
* well controlled on a standard clinical symptoms controlled dose of PPI treatment
* body mass index ≤32 kg/m2
Exclusion Criteria
* 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
18 Years
70 Years
ALL
No
Sponsors
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Addex Pharma S.A.
INDUSTRY
Responsible Party
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Addex Pharma SA
Locations
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Wien
Vienna, , Austria
Leuven
Leuven, , Belgium
Bordeaux
Bordeaux, , France
Lyon
Lyon, , France
Nantes
Nantes, , France
Berlin
Berlin, , Germany
Dresden
Dresden, , Germany
Gorlitz
Görlitz, , Germany
Leipzig
Leipzig, , Germany
Madgeburg 12
Magdeburg, , Germany
Magdeburg 13
Magdeburg, , Germany
Countries
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References
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Zerbib F, Bruley des Varannes S, Roman S, Tutuian R, Galmiche JP, Mion F, Tack J, Malfertheiner P, Keywood C. Randomised clinical trial: effects of monotherapy with ADX10059, a mGluR5 inhibitor, on symptoms and reflux events in patients with gastro-oesophageal reflux disease. Aliment Pharmacol Ther. 2011 Apr;33(8):911-21. doi: 10.1111/j.1365-2036.2011.04596.x. Epub 2011 Feb 14.
Other Identifiers
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2008-005104-10
Identifier Type: -
Identifier Source: secondary_id
ADX10059-204
Identifier Type: -
Identifier Source: org_study_id