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

Gastroesophageal Reflux Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00810485
• Other study ID #: ADX10059-205
• Secondary ID: 2008-005105-18
• Status: Completed
• Phase: Phase 2
• First received: December 17, 2008
• Last updated: July 13, 2012
• Start date: December 2008

Study information

• Verified date: July 2012
• Source: Addex Pharma S.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical DevicesNetherlands: Medicines Evaluation Board (MEB)Sweden: Medical Products AgencySwitzerland: Swissmedic
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 298
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastroesophageal Reflux

Intervention

Drug:
• ADX10059
oral administration
• ADX10059
oral administration
• ADX10059
oral administration
• ADX10059 Matching Placebo
oral administration

Locations

Country	Name	City	State
United States	54	Kansas City	Kansas
United States	62	Kansas City	Kansas
United States	71	Nashville	Tennessee
United States	73	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Addex Pharma S.A.

Countries where clinical trial is conducted

United States,  France,  Germany,  Netherlands,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of GERD symptom free days in week 4 of study medication treatment		4 weeks	No
Secondary	GERD symptoms		4 weeks	No
Secondary	Sleep disturbance		4 weeks	No
Secondary	Use of antacid medications		4 weeks	No
Secondary	Global assessment of GERD		4 weeks	No
Secondary	Safety and tolerability assessments		4 weeks	No