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

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ClinicalTrials.gov Identifier: NCT00810485
Recruitment Status : Completed
First Posted : December 18, 2008
Last Update Posted : July 16, 2012
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Gastroesophageal Reflux Drug: ADX10059 Drug: ADX10059 Matching Placebo Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 298 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : December 2008
Primary Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: ADX10059 50 mg
Drug: ADX10059
oral administration
Experimental: ADX10059 100 mg
Drug: ADX10059
oral administration
Experimental: ADX10059 150 mg
Drug: ADX10059
oral administration
Placebo Comparator: ADX10059 Matching Placebo
Drug: ADX10059 Matching Placebo
oral administration

Outcome Measures

Primary Outcome Measures :
  1. Number of GERD symptom free days in week 4 of study medication treatment [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. GERD symptoms [ Time Frame: 4 weeks ]
  2. Sleep disturbance [ Time Frame: 4 weeks ]
  3. Use of antacid medications [ Time Frame: 4 weeks ]
  4. Global assessment of GERD [ Time Frame: 4 weeks ]
  5. Safety and tolerability assessments [ Time Frame: 4 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00810485

  Hide Study 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
Kansas City, Kansas, United States
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
Nashville, Tennessee, United States
Nashville, Tennessee, United States
United States, Texas
Baytown, Texas, United States
Houston, Texas, United States
United States, Wisconsin
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
St Gallen, Switzerland
Sponsors and Collaborators
Addex Pharma S.A.
More Information

Responsible Party: Addex Pharma S.A.
ClinicalTrials.gov Identifier: NCT00810485     History of Changes
Other Study ID Numbers: ADX10059-205
First Posted: December 18, 2008    Key Record Dates
Last Update Posted: July 16, 2012
Last Verified: July 2012

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

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