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

Phase 2

Completed

• Conditions: Gastroesophageal Reflux
• Interventions: Drug: ADX10059; Drug: ADX10059 Matching Placebo

• Registration Number: NCT00820079
• Lead Sponsor: Addex Pharma S.A.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2009-01-08
• Study First Submitted QC: 2009-01-08
• Study First Posted: 2009-01-09
• Primary Completion: 2009-10
• Status Verified: 2009-12
• Last Update Submitted: 2009-12-23
• Last Update Posted: 2009-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ADX10059 120 mg	ADX10059	Twice-daily
ADX10059 Matching Placebo	ADX10059 Matching Placebo	twice-daily

Primary Outcome Measures

Name	Time	Method
Number of GERD symptom free days in week 2 of study medication treatment	2 weeks

Secondary Outcome Measures

Name	Time	Method
GERD symptoms	2 weeks
Sleep disturbance	2 weeks
Use of antacid rescue medication	2 weeks
Global assessment of GERD	2 weeks
Effect on lower oesophageal sphincter and reflux episodes	2 weeks

Trial Locations

Locations (11)

Wien; 🇦🇹 Wien, Austria

Leuven; 🇧🇪 Leuven, Belgium

Bordeaux; 🇫🇷 Bordeaux, France

Lyon; 🇫🇷 Lyon, France

Nantes; 🇫🇷 Nantes, France

Berlin; 🇩🇪 Berlin, Germany

Gorlitz; 🇩🇪 Gorlitz, Germany

Dresden; 🇩🇪 Dresden, Germany

Leipzig; 🇩🇪 Leipzig, Germany

Magdeburg 13; 🇩🇪 Magdeburg, Germany

Madgeburg 12; 🇩🇪 Magdeburg, Germany