- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00820079
ADX10059 as a Monotherapy in Patients With Gastroesophageal Reflux (GERD)
December 23, 2009 updated by: Addex Pharma S.A.
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)
Evaluation of the effect of ADX10059 on symptom control in patients with gastroesophageal reflux.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
120
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Wien, Austria
- Wien
-
-
-
-
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Leuven, Belgium
- Leuven
-
-
-
-
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Bordeaux, France
- Bordeaux
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Lyon, France
- Lyon
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Nantes, France
- Nantes
-
-
-
-
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Berlin, Germany
- Berlin
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Dresden, Germany
- Dresden
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Gorlitz, Germany
- Görlitz
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Leipzig, Germany
- Leipzig
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Magdeburg, Germany
- Madgeburg 12
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Magdeburg, Germany
- Magdeburg 13
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ADX10059 120 mg
Twice-daily
|
oral administration
|
Placebo Comparator: ADX10059 Matching Placebo
twice-daily
|
oral administration
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of GERD symptom free days in week 2 of study medication treatment
Time Frame: 2 weeks
|
2 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
GERD symptoms
Time Frame: 2 weeks
|
2 weeks
|
Sleep disturbance
Time Frame: 2 weeks
|
2 weeks
|
Use of antacid rescue medication
Time Frame: 2 weeks
|
2 weeks
|
Global assessment of GERD
Time Frame: 2 weeks
|
2 weeks
|
Effect on lower oesophageal sphincter and reflux episodes
Time Frame: 2 weeks
|
2 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2008
Primary Completion (Actual)
October 1, 2009
Study Completion
December 7, 2022
Study Registration Dates
First Submitted
January 8, 2009
First Submitted That Met QC Criteria
January 8, 2009
First Posted (Estimate)
January 9, 2009
Study Record Updates
Last Update Posted (Estimate)
December 24, 2009
Last Update Submitted That Met QC Criteria
December 23, 2009
Last Verified
December 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ADX10059-204
- 2008-005104-10
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Gastroesophageal Reflux
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GlaxoSmithKlineCompletedReflux, Gastroesophageal | Gastroesophageal Reflux DiseaseAustralia
-
University of North Carolina, Chapel HillNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)CompletedGastroesophageal Reflux Disease | GERD | Acid Reflux | RefluxUnited States
-
GlaxoSmithKlineCompletedReflux, Gastroesophageal | Gastroesophageal Reflux DiseaseAustralia
-
TakedaTerminatedGastroesophageal Reflux Disease | Non-erosive Reflux DiseaseSwitzerland, Netherlands
-
Klinikum Garmisch-PatenkirchenNot yet recruitingReflux, Gastroesophageal | Gastro-esophageal RefluxGermany
-
Mansoura UniversityWithdrawnGastroesophageal Reflux Disease
-
Cliniques universitaires Saint-Luc- Université...UnknownGastroesophageal Reflux DiseaseBelgium
-
King Chulalongkorn Memorial HospitalCompleted
-
Duke UniversityNational Heart, Lung, and Blood Institute (NHLBI)CompletedGastroesophageal Reflux Disease (GERD) | RefluxUnited States, Canada
-
Vanderbilt University Medical CenterCompletedGastroesophageal Reflux Disease (GERD) | Non-erosive Reflux Disease (NERD)United States
Clinical Trials on ADX10059
-
Addex Pharma S.A.Terminated
-
Addex Pharma S.A.CompletedGastroesophageal RefluxUnited States, France, Germany, Netherlands, Switzerland