ADX10059 as a Monotherapy in Patients With Gastroesophageal Reflux (GERD)
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)
2 other identifiers
interventional
120
4 countries
11
Brief Summary
Evaluation of the effect of ADX10059 on symptom control in patients with gastroesophageal reflux.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2008
CompletedFirst Submitted
Initial submission to the registry
January 8, 2009
CompletedFirst Posted
Study publicly available on registry
January 9, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2009
CompletedDecember 24, 2009
December 1, 2009
10 months
January 8, 2009
December 23, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of GERD symptom free days in week 2 of study medication treatment
2 weeks
Secondary Outcomes (5)
GERD symptoms
2 weeks
Sleep disturbance
2 weeks
Use of antacid rescue medication
2 weeks
Global assessment of GERD
2 weeks
Effect on lower oesophageal sphincter and reflux episodes
2 weeks
Study Arms (2)
ADX10059 120 mg
EXPERIMENTALTwice-daily
ADX10059 Matching Placebo
PLACEBO COMPARATORtwice-daily
Interventions
Eligibility Criteria
You may qualify if:
- diagnosis of typical GERD
- well controlled on a standard clinical symptoms controlled dose of PPI treatment
- body mass index ≤32 kg/m2
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Wien
Vienna, Austria
Leuven
Leuven, Belgium
Bordeaux
Bordeaux, France
Lyon
Lyon, France
Nantes
Nantes, France
Berlin
Berlin, Germany
Dresden
Dresden, Germany
Gorlitz
Görlitz, Germany
Leipzig
Leipzig, Germany
Madgeburg 12
Magdeburg, Germany
Magdeburg 13
Magdeburg, Germany
Related Publications (1)
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.
PMID: 21320138DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 8, 2009
First Posted
January 9, 2009
Study Start
December 1, 2008
Primary Completion
October 1, 2009
Last Updated
December 24, 2009
Record last verified: 2009-12