ADX10059 as an add-on Therapy to Proton Pump Inhibitors (PPIs) in Patients With Gastroesophageal Reflux (GERD)
NCT ID: NCT00810485
Last Updated: 2012-07-16
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
298 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 50 mg
twice-daily
ADX10059
oral administration
ADX10059 100 mg
twice-daily
ADX10059
oral administration
ADX10059 150 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
oral administration
ADX10059
oral administration
ADX10059 Matching Placebo
oral administration
Eligibility Criteria
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Inclusion Criteria
* partial responder to a stable standard clinical symptoms control dose of PPI therapy
* body mass index ≤ 32 kg/m2
Exclusion Criteria
* 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
18 Years
70 Years
ALL
No
Sponsors
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Addex Pharma S.A.
INDUSTRY
Responsible Party
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Locations
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Little Rock, Arizona, United States
Tucson, Arizona, United States
Anaheim, California, United States
San Diego, California, United States
Colorado Springs, Colorado, United States
Jacksonville, Florida, United States
Port Orange, Florida, United States
Moline, Illinois, United States
54
Kansas City, Kansas, United States
62
Kansas City, Kansas, United States
Jackson, Mississippi, United States
Setauket, New York, United States
Harrisburg, North Carolina, United States
High Point, North Carolina, United States
Huntersville, North Carolina, United States
Raleigh, North Carolina, United States
Winston-Salem, North Carolina, United States
Fargo, North Dakota, United States
Cleveland, Ohio, United States
Oklahoma City, Oklahoma, United States
Philadelphia, Pennsylvania, United States
Charleston, South Carolina, United States
Germantown, Tennessee, United States
71
Nashville, Tennessee, United States
73
Nashville, Tennessee, United States
Baytown, Texas, United States
Houston, Texas, United States
Waukesha, Wisconsin, United States
Bordeaux, , France
Colombes, , France
Lyon, , France
Nantes, , France
Nice, , France
Rouen, , France
Dresden, , Germany
Garmisch-Partenkirchen, , Germany
Magdeburg, , Germany
Munich, , Germany
Amsterdam, , Netherlands
Sankt Gallen, , Switzerland
Countries
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Other Identifiers
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2008-005105-18
Identifier Type: -
Identifier Source: secondary_id
ADX10059-205
Identifier Type: -
Identifier Source: org_study_id