Back to resultsADX10059 as a Monotherapy in Patients With Gastroesophageal Reflux (GERD)
Primary Purpose
Gastroesophageal Reflux
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ADX10059
ADX10059 Matching Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Gastroesophageal Reflux focused on measuring Gastroesophageal reflux, Heartburn, Regurgitation
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
Sites / Locations
- Wien
- Leuven
- Bordeaux
- Lyon
- Nantes
- Berlin
- Dresden
- Gorlitz
- Leipzig
- Madgeburg 12
- Magdeburg 13
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
ADX10059 120 mg
ADX10059 Matching Placebo
Arm Description
Twice-daily
twice-daily
Outcomes
Primary Outcome Measures
Number of GERD symptom free days in week 2 of study medication treatment
Secondary Outcome Measures
GERD symptoms
Sleep disturbance
Use of antacid rescue medication
Global assessment of GERD
Effect on lower oesophageal sphincter and reflux episodes
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00820079
Brief Title
ADX10059 as a Monotherapy in Patients With Gastroesophageal Reflux (GERD)
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)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2009
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Addex Pharma S.A.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Evaluation of the effect of ADX10059 on symptom control in patients with gastroesophageal reflux.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux
Keywords
Gastroesophageal reflux, Heartburn, Regurgitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ADX10059 120 mg
Arm Type
Experimental
Arm Description
Twice-daily
Arm Title
ADX10059 Matching Placebo
Arm Type
Placebo Comparator
Arm Description
twice-daily
Intervention Type
Drug
Intervention Name(s)
ADX10059
Intervention Description
oral administration
Intervention Type
Drug
Intervention Name(s)
ADX10059 Matching Placebo
Intervention Description
oral administration
Primary Outcome Measure Information:
Title
Number of GERD symptom free days in week 2 of study medication treatment
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
GERD symptoms
Time Frame
2 weeks
Title
Sleep disturbance
Time Frame
2 weeks
Title
Use of antacid rescue medication
Time Frame
2 weeks
Title
Global assessment of GERD
Time Frame
2 weeks
Title
Effect on lower oesophageal sphincter and reflux episodes
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Wien
City
Wien
Country
Austria
Facility Name
Leuven
City
Leuven
Country
Belgium
Facility Name
Bordeaux
City
Bordeaux
Country
France
Facility Name
Lyon
City
Lyon
Country
France
Facility Name
Nantes
City
Nantes
Country
France
Facility Name
Berlin
City
Berlin
Country
Germany
Facility Name
Dresden
City
Dresden
Country
Germany
Facility Name
Gorlitz
City
Gorlitz
Country
Germany
Facility Name
Leipzig
City
Leipzig
Country
Germany
Facility Name
Madgeburg 12
City
Magdeburg
Country
Germany
Facility Name
Magdeburg 13
City
Magdeburg
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
21320138
Citation
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.
Results Reference
derived
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ADX10059 as a Monotherapy in Patients With Gastroesophageal Reflux (GERD)
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