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

History of Changes

Tracking Information
First Received Date ^ICMJE	January 8, 2009
Last Updated Date	December 23, 2009
Start Date ^ICMJE	December 2008
Primary Completion Date	October 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: January 8, 2009)	Number of GERD symptom free days in week 2 of study medication treatment [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00820079 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: January 8, 2009)	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 ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	ADX10059 as a Monotherapy in Patients With Gastroesophageal Reflux (GERD)
Official Title ^ICMJE	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)
Brief Summary	Evaluation of the effect of ADX10059 on symptom control in patients with gastroesophageal reflux.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Condition ^ICMJE	Gastroesophageal Reflux
Intervention ^ICMJE	Drug: ADX10059 oral administration Drug: ADX10059 Matching Placebo oral administration
Study Arm (s)	Experimental: ADX10059 120 mg Twice-daily Intervention: Drug: ADX10059 Placebo Comparator: ADX10059 Matching Placebo twice-daily Intervention: Drug: ADX10059 Matching Placebo
Publications *	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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	120
Completion Date	Not Provided
Primary Completion Date	October 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 70 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Austria, Belgium, France, Germany

Administrative Information
NCT Number ^ICMJE	NCT00820079
Other Study ID Numbers ^ICMJE	ADX10059-204, 2008-005104-10
Has Data Monitoring Committee	No
Responsible Party	Study Director, Addex Pharma SA
Study Sponsor ^ICMJE	Addex Pharma S.A.
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Addex Pharma S.A.
Verification Date	December 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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