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

This study has been completed.
Sponsor:
Information provided by:
Addex Pharma S.A.
ClinicalTrials.gov Identifier:
NCT00820079
First received: January 8, 2009
Last updated: December 23, 2009
Last verified: December 2009
  Purpose

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


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, 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)

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 2 of study medication treatment [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • GERD symptoms [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Sleep disturbance [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Use of antacid rescue medication [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Global assessment of GERD [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Effect on lower oesophageal sphincter and reflux episodes [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: December 2008
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ADX10059 120 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
  • 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
  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: NCT00820079

Locations
Austria
Wien
Wien, Austria
Belgium
Leuven
Leuven, Belgium
France
Bordeaux
Bordeaux, France
Lyon
Lyon, France
Nantes
Nantes, France
Germany
Berlin
Berlin, Germany
Dresden
Dresden, Germany
Gorlitz
Gorlitz, Germany
Leipzig
Leipzig, Germany
Magdeburg 13
Magdeburg, Germany
Madgeburg 12
Magdeburg, Germany
Sponsors and Collaborators
Addex Pharma S.A.
  More Information

No publications provided by Addex Pharma S.A.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Study Director, Addex Pharma SA
ClinicalTrials.gov Identifier: NCT00820079     History of Changes
Other Study ID Numbers: ADX10059-204, 2008-005104-10
Study First Received: January 8, 2009
Last Updated: December 23, 2009
Health Authority: Austria: Federal Office for Safety in Health Care
Belgium: Federal Agency for Medicinal Products and Health Products
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)

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

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on July 29, 2014