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ADX10059 as a Monotherapy in Patients With Gastroesophageal Reflux (GERD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00820079
Recruitment Status : Completed
First Posted : January 9, 2009
Last Update Posted : December 24, 2009
Sponsor:
Information provided by:
Addex Pharma S.A.

Study Description
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Brief Summary:
Evaluation of the effect of ADX10059 on symptom control in patients with gastroesophageal reflux.

Condition or disease Intervention/treatment Phase
Gastroesophageal Reflux Drug: ADX10059 Drug: ADX10059 Matching Placebo Phase 2

Study Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Number of GERD symptom free days in week 2 of study medication treatment [ Time Frame: 2 weeks ]

Secondary Outcome Measures :
  1. GERD symptoms [ Time Frame: 2 weeks ]
  2. Sleep disturbance [ Time Frame: 2 weeks ]
  3. Use of antacid rescue medication [ Time Frame: 2 weeks ]
  4. Global assessment of GERD [ Time Frame: 2 weeks ]
  5. Effect on lower oesophageal sphincter and reflux episodes [ Time Frame: 2 weeks ]

Eligibility Criteria
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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
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
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Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
Addex Pharma S.A.
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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
Keywords provided by Addex Pharma S.A.:
Gastroesophageal reflux
Heartburn
Regurgitation
Additional relevant MeSH terms:
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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