ADX10059 as a Monotherapy in Patients With Gastroesophageal Reflux (GERD)
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ClinicalTrials.gov Identifier: NCT00820079 |
Recruitment Status :
Completed
First Posted : January 9, 2009
Last Update Posted : December 24, 2009
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Gastroesophageal Reflux | Drug: ADX10059 Drug: ADX10059 Matching Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 120 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
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 Start Date : | December 2008 |
Actual Primary Completion Date : | October 2009 |
Arm | Intervention/treatment |
---|---|
Experimental: ADX10059 120 mg
Twice-daily
|
Drug: ADX10059
oral administration |
Placebo Comparator: ADX10059 Matching Placebo
twice-daily
|
Drug: ADX10059 Matching Placebo
oral administration |
- Number of GERD symptom free days in week 2 of study medication treatment [ Time Frame: 2 weeks ]
- GERD symptoms [ Time Frame: 2 weeks ]
- Sleep disturbance [ Time Frame: 2 weeks ]
- Use of antacid rescue medication [ Time Frame: 2 weeks ]
- Global assessment of GERD [ Time Frame: 2 weeks ]
- Effect on lower oesophageal sphincter and reflux episodes [ Time Frame: 2 weeks ]

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00820079
Austria | |
Wien | |
Wien, Austria | |
Belgium | |
Leuven | |
Leuven, Belgium | |
France | |
Bordeaux | |
Bordeaux, France | |
Lyon | |
Lyon, France | |
Nantes | |
Nantes, France | |
Germany | |
Berlin | |
Berlin, Germany | |
Dresden | |
Dresden, Germany | |
Gorlitz | |
Gorlitz, Germany | |
Leipzig | |
Leipzig, Germany | |
Madgeburg 12 | |
Magdeburg, Germany | |
Magdeburg 13 | |
Magdeburg, Germany |
Responsible Party: | Study Director, Addex Pharma SA |
ClinicalTrials.gov Identifier: | NCT00820079 |
Other Study ID Numbers: |
ADX10059-204 2008-005104-10 |
First Posted: | January 9, 2009 Key Record Dates |
Last Update Posted: | December 24, 2009 |
Last Verified: | December 2009 |
Gastroesophageal reflux Heartburn Regurgitation |
Gastroesophageal Reflux Esophagitis, Peptic Esophageal Motility Disorders Deglutition Disorders Esophageal Diseases Gastrointestinal Diseases Digestive System Diseases |
Esophagitis Gastroenteritis Peptic Ulcer Duodenal Diseases Intestinal Diseases Stomach Diseases |