Clinical trial NCT00810485: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gastroesophageal Reflux
Keywords: Gastroesophageal reflux
Proton pump inhibitor
Heartburn
Regurgitation
Lead sponsor: Addex Pharma S.A.
Sponsor class: INDUSTRY
First posted: 2008-12-18
Enrollment: 298
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Number of GERD symptom free days in week 4 of study medication treatment
timeFrame: 4 weeks
Secondary outcomes:
measure: GERD symptoms
timeFrame: 4 weeks
measure: Sleep disturbance
timeFrame: 4 weeks
measure: Use of antacid medications
timeFrame: 4 weeks
measure: Global assessment of GERD
timeFrame: 4 weeks
measure: Safety and tolerability assessments
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Little Rock
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Anaheim
country: United States
state: California
city: San Diego
country: United States
state: California
city: Colorado Springs
country: United States
state: Colorado
city: Jacksonville
country: United States
state: Florida
city: Port Orange
country: United States
state: Florida
city: Moline
country: United States
state: Illinois
city: Kansas City
country: United States
facility: 54
state: Kansas
city: Kansas City
country: United States
facility: 62
state: Kansas
city: Jackson
country: United States
state: Mississippi
city: Setauket
country: United States
state: New York
city: Harrisburg
country: United States
state: North Carolina
city: High Point
country: United States
state: North Carolina
city: Huntersville
country: United States
state: North Carolina
city: Raleigh
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Fargo
country: United States
state: North Dakota
city: Cleveland
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Philadelphia
country: United States
state: Pennsylvania
city: Charleston
country: United States
state: South Carolina
city: Germantown
country: United States
state: Tennessee
city: Nashville
country: United States
facility: 71
state: Tennessee
city: Nashville
country: United States
facility: 73
state: Tennessee
city: Baytown
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Waukesha
country: United States
state: Wisconsin
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
Study officials:
References: