Back to resultsADX10059 as an add-on Therapy to Proton Pump Inhibitors (PPIs) in Patients With Gastroesophageal Reflux (GERD)
Primary Purpose
Gastroesophageal Reflux
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ADX10059
ADX10059
ADX10059
ADX10059 Matching Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Gastroesophageal Reflux focused on measuring Gastroesophageal reflux, Proton pump inhibitor, Heartburn, Regurgitation
Eligibility Criteria
Inclusion Criteria:
- diagnosis of typical GERD
- partial responder to a stable standard clinical symptoms control dose of PPI therapy
- body mass index ≤ 32 kg/m2
Exclusion Criteria:
- 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
Sites / Locations
- 54
- 62
- 71
- 73
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
ADX10059 50 mg
ADX10059 100 mg
ADX10059 150 mg
ADX10059 Matching Placebo
Arm Description
twice-daily
twice-daily
twice-daily
twice-daily
Outcomes
Primary Outcome Measures
Number of GERD symptom free days in week 4 of study medication treatment
Secondary Outcome Measures
GERD symptoms
Sleep disturbance
Use of antacid medications
Global assessment of GERD
Safety and tolerability assessments
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00810485
Brief Title
ADX10059 as an add-on Therapy to Proton Pump Inhibitors (PPIs) in Patients With Gastroesophageal Reflux (GERD)
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Addex Pharma S.A.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux
Keywords
Gastroesophageal reflux, Proton pump inhibitor, Heartburn, Regurgitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
298 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ADX10059 50 mg
Arm Type
Experimental
Arm Description
twice-daily
Arm Title
ADX10059 100 mg
Arm Type
Experimental
Arm Description
twice-daily
Arm Title
ADX10059 150 mg
Arm Type
Experimental
Arm Description
twice-daily
Arm Title
ADX10059 Matching Placebo
Arm Type
Placebo Comparator
Arm Description
twice-daily
Intervention Type
Drug
Intervention Name(s)
ADX10059
Intervention Description
oral administration
Intervention Type
Drug
Intervention Name(s)
ADX10059
Intervention Description
oral administration
Intervention Type
Drug
Intervention Name(s)
ADX10059
Intervention Description
oral administration
Intervention Type
Drug
Intervention Name(s)
ADX10059 Matching Placebo
Intervention Description
oral administration
Primary Outcome Measure Information:
Title
Number of GERD symptom free days in week 4 of study medication treatment
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
GERD symptoms
Time Frame
4 weeks
Title
Sleep disturbance
Time Frame
4 weeks
Title
Use of antacid medications
Time Frame
4 weeks
Title
Global assessment of GERD
Time Frame
4 weeks
Title
Safety and tolerability assessments
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
diagnosis of typical GERD
partial responder to a stable standard clinical symptoms control dose of PPI therapy
body mass index ≤ 32 kg/m2
Exclusion Criteria:
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
Facility Information:
City
Little Rock
State/Province
Arizona
Country
United States
City
Tucson
State/Province
Arizona
Country
United States
City
Anaheim
State/Province
California
Country
United States
City
San Diego
State/Province
California
Country
United States
City
Colorado Springs
State/Province
Colorado
Country
United States
City
Jacksonville
State/Province
Florida
Country
United States
City
Port Orange
State/Province
Florida
Country
United States
City
Moline
State/Province
Illinois
Country
United States
Facility Name
54
City
Kansas City
State/Province
Kansas
Country
United States
Facility Name
62
City
Kansas City
State/Province
Kansas
Country
United States
City
Jackson
State/Province
Mississippi
Country
United States
City
Setauket
State/Province
New York
Country
United States
City
Harrisburg
State/Province
North Carolina
Country
United States
City
High Point
State/Province
North Carolina
Country
United States
City
Huntersville
State/Province
North Carolina
Country
United States
City
Raleigh
State/Province
North Carolina
Country
United States
City
Winston-Salem
State/Province
North Carolina
Country
United States
City
Fargo
State/Province
North Dakota
Country
United States
City
Cleveland
State/Province
Ohio
Country
United States
City
Oklahoma City
State/Province
Oklahoma
Country
United States
City
Philadelphia
State/Province
Pennsylvania
Country
United States
City
Charleston
State/Province
South Carolina
Country
United States
City
Germantown
State/Province
Tennessee
Country
United States
Facility Name
71
City
Nashville
State/Province
Tennessee
Country
United States
Facility Name
73
City
Nashville
State/Province
Tennessee
Country
United States
City
Baytown
State/Province
Texas
Country
United States
City
Houston
State/Province
Texas
Country
United States
City
Waukesha
State/Province
Wisconsin
Country
United States
City
Bordeaux
Country
France
City
Colombes
Country
France
City
Lyon
Country
France
City
Nantes
Country
France
City
Nice
Country
France
City
Rouen
Country
France
City
Dresden
Country
Germany
City
Garmisch Partenkirchen
Country
Germany
City
Magdeburg
Country
Germany
City
Munich
Country
Germany
City
Amsterdam
Country
Netherlands
City
St Gallen
Country
Switzerland
12. IPD Sharing Statement
Learn more about this trial
ADX10059 as an add-on Therapy to Proton Pump Inhibitors (PPIs) in Patients With Gastroesophageal Reflux (GERD)
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