ADX10059 as an Add-on Therapy to Proton Pump Inhibitors (PPIs) in Patients With Gastroesophageal Reflux (GERD) - Full Text View

Sponsored by:	Addex Pharma S.A.
Information provided by:	Addex Pharma S.A.
ClinicalTrials.gov Identifier:	NCT00810485

Purpose

The purpose of this study is to evaluate the effect of ADX10059 in patients with gastroesophageal reflux disease who are partial responders to proton pump inhibitors

Condition	Intervention	Phase
Gastroesophageal Reflux	Drug: ADX10059 Drug: ADX10059 Matching Placebo	Phase II

MedlinePlus related topics: GERD

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase 2B, Randomised, Double-Blind, Placebo-Controlled, Parallel Group, Dose-Ranging, Multi-Centre Study to Investigate the Efficacy, Safety and Tolerability of the mGluR5 Negative Allosteric Modulator ADX10059 in Patients With Gastroesophageal Reflux Disease (GERD) Who Are Partial Responders to Proton Pump Inhibitor (PPI) Treatment

Further study details as provided by Addex Pharma S.A.:

Primary Outcome Measures:

Number of GERD symptom free days in week 4 of study medication treatment [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

GERD symptoms [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Sleep disturbance [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Use of antacid medications [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Global assessment of GERD [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Safety and tolerability assessments [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	320
Study Start Date:	December 2008
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
ADX10059 50 mg: Experimental twice-daily	Drug: ADX10059 oral administration
ADX10059 100 mg: Experimental twice-daily	Drug: ADX10059 oral administration
ADX10059 150 mg: Experimental twice-daily	Drug: ADX10059 oral administration
ADX10059 Matching Placebo: Placebo Comparator 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
partial responder to a stable standard clinical symptoms control dose of PPI therapy
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
treated with a dose of PPI greater than the dose indicated for clinical symptom control of GERD
hiatus hernia > 3 cm
current diagnosis of co-existing psychiatric disease
known clinical significant allergy or known hypersensitivity to drugs
is 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: NCT00810485

Contacts

Contact: Study Director

0041228841555

info@addexpharma.com

Show 36 Study Locations

Sponsors and Collaborators

Addex Pharma S.A.

More Information

Responsible Party:	Addex Pharma SA ( Study Director )
Study ID Numbers:	ADX10059-205, 2008-005105-18
Study First Received:	December 17, 2008
Last Updated:	January 8, 2009
ClinicalTrials.gov Identifier:	NCT00810485
Health Authority:	United States: Food and Drug Administration; France: Afssaps - French Health Products Safety Agency; Germany: Federal Institute for Drugs and Medical Devices; Netherlands: Medicines Evaluation Board (MEB); Sweden: Medical Products Agency; Switzerland: Swissmedic

Keywords provided by Addex Pharma S.A.:

Gastroesophageal reflux
Proton pump inhibitor
Heartburn
Regurgitation

Study placed in the following topic categories:

Deglutition Disorders
Esophageal Motility Disorders
Pyrosis
Digestive System Diseases
Esophageal disorder

Gastrointestinal Diseases
Heartburn
Esophageal Diseases
Gastroesophageal Reflux

ClinicalTrials.gov processed this record on January 14, 2009