ADX10059 as a Monotherapy in Patients With Gastroesophage... | NCT00820079

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

NCT00820079

Sponsor

Addex Pharma S.A.

Status

Completed

Last Update Posted

Dec 24, 2009Estimated

Enrollment

120Estimated

Phase

Phase 2

Conditions

Gastroesophageal Reflux

Interventions

ADX10059
ADX10059 Matching Placebo

Countries

Austria
Belgium
France
Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2008-005104-10

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)

Status Module

Record Verification Date

Dec 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2008

Primary Completion Date

Oct 2009Actual

Completion Date

Not provided

First Submitted Date

Jan 8, 2009

First Submission Date that Met QC Criteria

Jan 8, 2009

First Posted Date

Jan 9, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 23, 2009

Last Update Posted Date

Dec 24, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ADX10059 120 mg	Experimental	Twice-daily	Drug: ADX10059
ADX10059 Matching Placebo	Placebo Comparator	twice-daily	Drug: ADX10059 Matching Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ADX10059	Drug	oral administration	ADX10059 120 mg
ADX10059 Matching Placebo

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
GERD symptoms		2 weeks
Sleep disturbance		2 weeks
Use of antacid rescue medication

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21320138	Derived	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. doi: 10.1111/j.1365-2036.2011.04596.x. Epub 2011 Feb 14.

Facility	Status	City	State	ZIP	Country	Contacts
Wien		Vienna			Austria
Leuven

ID	Term
D005764	Gastroesophageal Reflux
D006356	Heartburn

ID	Term
D015154	Esophageal Motility Disorders
D003680	Deglutition Disorders
D004935	Esophageal Diseases
D005767	Gastrointestinal Diseases