ADX10059 as an add-on Therapy to Proton Pump Inhibitors (PPIs) in Patients With Gastroesophageal Reflux (GERD)
A Phase 2B, Randomised, Double-blind, Placebo-controlled, Parallel Group, Dose-ranging, Multi-centre Study to Investigate the Efficacy, Safety and Tolerability of the mGluR5 Negative Allosteric Modulator ADX10059 in Patients With Gastroesophageal Reflux Disease (GERD) Who Are Partial Responders to Proton Pump Inhibitor (PPI) Treatment
2 other identifiers
interventional
298
5 countries
40
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
40 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2008
CompletedFirst Submitted
Initial submission to the registry
December 17, 2008
CompletedFirst Posted
Study publicly available on registry
December 18, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedJuly 16, 2012
July 1, 2012
1 year
December 17, 2008
July 13, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of GERD symptom free days in week 4 of study medication treatment
4 weeks
Secondary Outcomes (5)
GERD symptoms
4 weeks
Sleep disturbance
4 weeks
Use of antacid medications
4 weeks
Global assessment of GERD
4 weeks
Safety and tolerability assessments
4 weeks
Study Arms (4)
ADX10059 50 mg
EXPERIMENTALtwice-daily
ADX10059 100 mg
EXPERIMENTALtwice-daily
ADX10059 150 mg
EXPERIMENTALtwice-daily
ADX10059 Matching Placebo
PLACEBO COMPARATORtwice-daily
Interventions
Eligibility Criteria
You may qualify if:
- diagnosis of typical GERD
- partial responder to a stable standard clinical symptoms control dose of PPI therapy
- body mass index ≤ 32 kg/m2
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (40)
Unknown Facility
Little Rock, Arizona, United States
Unknown Facility
Tucson, Arizona, United States
Unknown Facility
Anaheim, California, United States
Unknown Facility
San Diego, California, United States
Unknown Facility
Colorado Springs, Colorado, United States
Unknown Facility
Jacksonville, Florida, United States
Unknown Facility
Port Orange, Florida, United States
Unknown Facility
Moline, Illinois, United States
54
Kansas City, Kansas, United States
62
Kansas City, Kansas, United States
Unknown Facility
Jackson, Mississippi, United States
Unknown Facility
Setauket, New York, United States
Unknown Facility
Harrisburg, North Carolina, United States
Unknown Facility
High Point, North Carolina, United States
Unknown Facility
Huntersville, North Carolina, United States
Unknown Facility
Raleigh, North Carolina, United States
Unknown Facility
Winston-Salem, North Carolina, United States
Unknown Facility
Fargo, North Dakota, United States
Unknown Facility
Cleveland, Ohio, United States
Unknown Facility
Oklahoma City, Oklahoma, United States
Unknown Facility
Philadelphia, Pennsylvania, United States
Unknown Facility
Charleston, South Carolina, United States
Unknown Facility
Germantown, Tennessee, United States
71
Nashville, Tennessee, United States
73
Nashville, Tennessee, United States
Unknown Facility
Baytown, Texas, United States
Unknown Facility
Houston, Texas, United States
Unknown Facility
Waukesha, Wisconsin, United States
Unknown Facility
Bordeaux, France
Unknown Facility
Colombes, France
Unknown Facility
Lyon, France
Unknown Facility
Nantes, France
Unknown Facility
Nice, France
Unknown Facility
Rouen, France
Unknown Facility
Dresden, Germany
Unknown Facility
Garmisch-Partenkirchen, Germany
Unknown Facility
Magdeburg, Germany
Unknown Facility
Munich, Germany
Unknown Facility
Amsterdam, Netherlands
Unknown Facility
Sankt Gallen, Switzerland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 17, 2008
First Posted
December 18, 2008
Study Start
December 1, 2008
Primary Completion
December 1, 2009
Last Updated
July 16, 2012
Record last verified: 2012-07