ADX10059 as a Monotherapy in Patients With Gastroesophageal Reflux (GERD)
This study has been completed.
Sponsor:
Addex Pharma S.A.
Information provided by:
Addex Pharma S.A.
ClinicalTrials.gov Identifier:
NCT00820079
First received: January 8, 2009
Last updated: December 23, 2009
Last verified: December 2009
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Purpose
Evaluation of the effect of ADX10059 on symptom control in patients with gastroesophageal reflux.
| Condition | Intervention | Phase |
|---|---|---|
|
Gastroesophageal Reflux |
Drug: ADX10059 Drug: ADX10059 Matching Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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) |
Resource links provided by NLM:
Further study details as provided by Addex Pharma S.A.:
Primary Outcome Measures:
- Number of GERD symptom free days in week 2 of study medication treatment [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- GERD symptoms [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
- Sleep disturbance [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
- Use of antacid rescue medication [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
- Global assessment of GERD [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
- Effect on lower oesophageal sphincter and reflux episodes [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 120 |
| Study Start Date: | December 2008 |
| Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: ADX10059 120 mg
Twice-daily
|
Drug: ADX10059
oral administration
|
|
Placebo Comparator: ADX10059 Matching Placebo
twice-daily
|
Drug: ADX10059 Matching Placebo
oral administration
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00820079
Locations
| 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 | |
| Magdeburg 13 | |
| Magdeburg, Germany | |
| Madgeburg 12 | |
| Magdeburg, Germany | |
Sponsors and Collaborators
Addex Pharma S.A.
More Information
No publications provided by Addex Pharma S.A.
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Study Director, Addex Pharma SA |
| ClinicalTrials.gov Identifier: | NCT00820079 History of Changes |
| Other Study ID Numbers: | ADX10059-204, 2008-005104-10 |
| Study First Received: | January 8, 2009 |
| Last Updated: | December 23, 2009 |
| Health Authority: | Austria: Federal Office for Safety in Health Care Belgium: Federal Agency for Medicinal Products and Health Products France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Germany: Federal Institute for Drugs and Medical Devices Netherlands: Medicines Evaluation Board (MEB) |
Keywords provided by Addex Pharma S.A.:
|
Gastroesophageal reflux Heartburn Regurgitation |
Additional relevant MeSH terms:
|
Gastroesophageal Reflux Esophageal Motility Disorders Deglutition Disorders |
Esophageal Diseases Gastrointestinal Diseases Digestive System Diseases |
ClinicalTrials.gov processed this record on May 21, 2013