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

This study has been completed.
Information provided by:
Addex Pharma S.A. Identifier:
First received: January 8, 2009
Last updated: December 23, 2009
Last verified: December 2009
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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 ]

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

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
Drug: ADX10059
oral administration
Placebo Comparator: ADX10059 Matching Placebo
Drug: ADX10059 Matching Placebo
oral administration


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
  • 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 identifier: NCT00820079

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Study Director, Addex Pharma SA Identifier: NCT00820079     History of Changes
Other Study ID Numbers: ADX10059-204
Study First Received: January 8, 2009
Last Updated: December 23, 2009

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

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases processed this record on September 21, 2017