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ADX10059 as an add-on Therapy to Proton Pump Inhibitors (PPIs) in Patients With Gastroesophageal Reflux (GERD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Addex Pharma S.A.
ClinicalTrials.gov Identifier:
NCT00810485
First received: December 17, 2008
Last updated: July 13, 2012
Last verified: July 2012

December 17, 2008
July 13, 2012
December 2008
December 2009   (final data collection date for primary outcome measure)
Number of GERD symptom free days in week 4 of study medication treatment [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00810485 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
ADX10059 as an add-on Therapy to Proton Pump Inhibitors (PPIs) in Patients With Gastroesophageal Reflux (GERD)
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

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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Gastroesophageal Reflux
  • Drug: ADX10059
    oral administration
  • Drug: ADX10059 Matching Placebo
    oral administration
  • Experimental: ADX10059 50 mg
    twice-daily
    Intervention: Drug: ADX10059
  • Experimental: ADX10059 100 mg
    twice-daily
    Intervention: Drug: ADX10059
  • Experimental: ADX10059 150 mg
    twice-daily
    Intervention: Drug: ADX10059
  • Placebo Comparator: ADX10059 Matching Placebo
    twice-daily
    Intervention: Drug: ADX10059 Matching Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
298
Not Provided
December 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   France,   Germany,   Netherlands,   Switzerland
 
NCT00810485
ADX10059-205, 2008-005105-18
No
Addex Pharma S.A.
Addex Pharma S.A.
Not Provided
Not Provided
Addex Pharma S.A.
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP