ADX10059 as a Monotherapy in Patients With Gastroesophageal Reflux (GERD)

December 23, 2009 updated by: Addex Pharma S.A.

A Phase 2B, Randomised, Double-blind, Placebo-controlled, Parallel Group, Multi-centre Study to Investigate the Efficacy, Mechanism of Action, Pharmacokinetics, Safety and Tolerability of the mGluR5 Negative Allosteric Modulator ADX10059 as Monotherapy in Patients With Gastroesophageal Reflux Disease (GERD)

Evaluation of the effect of ADX10059 on symptom control in patients with gastroesophageal reflux.

Study Overview

Status

Completed

Study Type

Interventional

Enrollment (Anticipated)

120

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

      • Wien, Austria
        • Wien
      • Leuven, Belgium
        • Leuven
      • Bordeaux, France
        • Bordeaux
      • Lyon, France
        • Lyon
      • Nantes, France
        • Nantes
      • Berlin, Germany
        • Berlin
      • Dresden, Germany
        • Dresden
      • Gorlitz, Germany
        • Görlitz
      • Leipzig, Germany
        • Leipzig
      • Magdeburg, Germany
        • Madgeburg 12
      • Magdeburg, Germany
        • Magdeburg 13

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
  • well controlled on a standard clinical symptoms controlled dose of PPI treatment
  • 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
  • hiatus hernia > 3 cm
  • current diagnosis of co-existing psychiatric disease
  • known clinically significant allergy or known hypersensitivity to drugs
  • 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
Experimental: ADX10059 120 mg
Twice-daily
oral administration
Placebo Comparator: ADX10059 Matching Placebo
twice-daily
oral administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of GERD symptom free days in week 2 of study medication treatment
Time Frame: 2 weeks
2 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
GERD symptoms
Time Frame: 2 weeks
2 weeks
Sleep disturbance
Time Frame: 2 weeks
2 weeks
Use of antacid rescue medication
Time Frame: 2 weeks
2 weeks
Global assessment of GERD
Time Frame: 2 weeks
2 weeks
Effect on lower oesophageal sphincter and reflux episodes
Time Frame: 2 weeks
2 weeks

Collaborators and Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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)

October 1, 2009

Study Completion

December 7, 2022

Study Registration Dates

First Submitted

January 8, 2009

First Submitted That Met QC Criteria

January 8, 2009

First Posted (Estimate)

January 9, 2009

Study Record Updates

Last Update Posted (Estimate)

December 24, 2009

Last Update Submitted That Met QC Criteria

December 23, 2009

Last Verified

December 1, 2009

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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