ADX10059 as an add-on Therapy to Proton Pump Inhibitors (PPIs) in Patients With Gastroesophageal Reflux (GERD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Addex Pharma S.A.
ClinicalTrials.gov Identifier:
NCT00810485
First received: December 17, 2008
Last updated: July 13, 2012
Last verified: July 2012
  Purpose

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


Condition Intervention Phase
Gastroesophageal Reflux
Drug: ADX10059
Drug: ADX10059 Matching Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Addex Pharma S.A.:

Primary Outcome Measures:
  • Number of GERD symptom free days in week 4 of study medication treatment [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • GERD symptoms [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Sleep disturbance [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Use of antacid medications [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Global assessment of GERD [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Safety and tolerability assessments [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 298
Study Start Date: December 2008
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ADX10059 50 mg
twice-daily
Drug: ADX10059
oral administration
Experimental: ADX10059 100 mg
twice-daily
Drug: ADX10059
oral administration
Experimental: ADX10059 150 mg
twice-daily
Drug: ADX10059
oral administration
Placebo Comparator: ADX10059 Matching Placebo
twice-daily
Drug: ADX10059 Matching Placebo
oral administration

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00810485

  Hide Study Locations
Locations
United States, Arizona
Little Rock, Arizona, United States
Tucson, Arizona, United States
United States, California
Anaheim, California, United States
San Diego, California, United States
United States, Colorado
Colorado Springs, Colorado, United States
United States, Florida
Jacksonville, Florida, United States
Port Orange, Florida, United States
United States, Illinois
Moline, Illinois, United States
United States, Kansas
62
Kansas City, Kansas, United States
54
Kansas City, Kansas, United States
United States, Mississippi
Jackson, Mississippi, United States
United States, New York
Setauket, New York, United States
United States, North Carolina
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
United States, North Dakota
Fargo, North Dakota, United States
United States, Ohio
Cleveland, Ohio, United States
United States, Oklahoma
Oklahoma City, Oklahoma, United States
United States, Pennsylvania
Philadelphia, Pennsylvania, United States
United States, South Carolina
Charleston, South Carolina, United States
United States, Tennessee
Germantown, Tennessee, United States
71
Nashville, Tennessee, United States
73
Nashville, Tennessee, United States
United States, Texas
Baytown, Texas, United States
Houston, Texas, United States
United States, Wisconsin
Waukesha, Wisconsin, United States
France
Bordeaux, France
Colombes, France
Lyon, France
Nantes, France
Nice, France
Rouen, France
Germany
Dresden, Germany
Garmisch Partenkirchen, Germany
Magdeburg, Germany
Munich, Germany
Netherlands
Amsterdam, Netherlands
Switzerland
St Gallen, Switzerland
Sponsors and Collaborators
Addex Pharma S.A.
  More Information

No publications provided

Responsible Party: Addex Pharma S.A.
ClinicalTrials.gov Identifier: NCT00810485     History of Changes
Other Study ID Numbers: ADX10059-205, 2008-005105-18
Study First Received: December 17, 2008
Last Updated: July 13, 2012
Health Authority: United States: Food and Drug Administration
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Netherlands: Medicines Evaluation Board (MEB)
Sweden: Medical Products Agency
Switzerland: Swissmedic

Keywords provided by Addex Pharma S.A.:
Gastroesophageal reflux
Proton pump inhibitor
Heartburn
Regurgitation

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014