ADX10059 as a Monotherapy in Patients With Gastroesophageal Reflux (GERD) - Full Text View

Sponsor:	Addex Pharma S.A.
Information provided by:	Addex Pharma S.A.
ClinicalTrials.gov Identifier:	NCT00820079

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:

MedlinePlus related topics: GERD

U.S. FDA Resources

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

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):

Zerbib F, Bruley des Varannes S, Roman S, Tutuian R, Galmiche JP, Mion F, Tack J, Malfertheiner P, Keywood C. Randomised clinical trial: effects of monotherapy with ADX10059, a mGluR5 inhibitor, on symptoms and reflux events in patients with gastro-oesophageal reflux disease. Aliment Pharmacol Ther. 2011 Apr;33(8):911-21. Epub 2011 Feb 14.

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 - French Health Products Safety Agency 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 May 23, 2012