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

July 13, 2012 updated by: Addex Pharma S.A.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

298

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • 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
  • United States
    • Arizona
      • Little Rock, Arizona, United States
      • Tucson, Arizona, United States
    • California
      • Anaheim, California, United States
      • San Diego, California, United States
    • Colorado
      • Colorado Springs, Colorado, United States
    • Florida
      • Jacksonville, Florida, United States
      • Port Orange, Florida, United States
    • Illinois
      • Moline, Illinois, United States
    • Kansas
      • Kansas City, Kansas, United States
        • 54
      • Kansas City, Kansas, United States
        • 62
    • Mississippi
      • Jackson, Mississippi, United States
    • New York
      • Setauket, New York, 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
    • North Dakota
      • Fargo, North Dakota, United States
    • Ohio
      • Cleveland, Ohio, United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
    • South Carolina
      • Charleston, South Carolina, United States
    • Tennessee
      • Germantown, Tennessee, United States
      • Nashville, Tennessee, United States
        • 71
      • Nashville, Tennessee, United States
        • 73
    • Texas
      • Baytown, Texas, United States
      • Houston, Texas, United States
    • Wisconsin
      • Waukesha, Wisconsin, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: ADX10059 Matching Placebo
twice-daily
Drug: ADX10059 Matching Placebo
oral administration
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of GERD symptom free days in week 4 of study medication treatment
Time Frame: 4 weeks
4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
GERD symptoms
Time Frame: 4 weeks
4 weeks
Sleep disturbance
Time Frame: 4 weeks
4 weeks
Use of antacid medications
Time Frame: 4 weeks
4 weeks
Global assessment of GERD
Time Frame: 4 weeks
4 weeks
Safety and tolerability assessments
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Addex Pharma S.A.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

December 17, 2008

First Submitted That Met QC Criteria

December 17, 2008

First Posted (Estimate)

December 18, 2008

Study Record Updates

Last Update Posted (Estimate)

July 16, 2012

Last Update Submitted That Met QC Criteria

July 13, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ADX10059-205
  • 2008-005105-18

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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