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

Gastroesophageal Reflux Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00820079
• Other study ID #: ADX10059-204
• Secondary ID: 2008-005104-10
• Status: Completed
• Phase: Phase 2
• First received: January 8, 2009
• Last updated: December 23, 2009
• Start date: December 2008

Study information

• Verified date: December 2009
• Source: Addex Pharma S.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Office for Safety in Health CareBelgium: Federal Agency for Medicinal Products and Health ProductsFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical DevicesNetherlands: Medicines Evaluation Board (MEB)
• Study type: Interventional

Clinical Trial Summary

Evaluation of the effect of ADX10059 on symptom control in patients with gastroesophageal reflux.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

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 Matching Placebo
oral administration

Locations

Country	Name	City	State
Austria	Wien	Wien
Belgium	Leuven	Leuven
France	Bordeaux	Bordeaux
France	Lyon	Lyon
France	Nantes	Nantes
Germany	Berlin	Berlin
Germany	Dresden	Dresden
Germany	Gorlitz	Gorlitz
Germany	Leipzig	Leipzig
Germany	Madgeburg 12	Magdeburg
Germany	Magdeburg 13	Magdeburg

Sponsors (1)

Lead Sponsor	Collaborator
Addex Pharma S.A.

Countries where clinical trial is conducted

Austria,  Belgium,  France,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of GERD symptom free days in week 2 of study medication treatment		2 weeks	No
Secondary	GERD symptoms		2 weeks	No
Secondary	Sleep disturbance		2 weeks	No
Secondary	Use of antacid rescue medication		2 weeks	No
Secondary	Global assessment of GERD		2 weeks	No
Secondary	Effect on lower oesophageal sphincter and reflux episodes		2 weeks	No