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

Phase 2

Completed

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

• Registration Number: NCT00810485
• Lead Sponsor: Addex Pharma S.A.

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2008-12-17
• Study First Submitted QC: 2008-12-17
• Study First Posted: 2008-12-18
• Primary Completion: 2009-12
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-13
• Last Update Posted: 2012-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 298

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ADX10059 100 mg	ADX10059	twice-daily
ADX10059 Matching Placebo	ADX10059 Matching Placebo	twice-daily
ADX10059 50 mg	ADX10059	twice-daily
ADX10059 150 mg	ADX10059	twice-daily

Primary Outcome Measures

Name	Time	Method
Number of GERD symptom free days in week 4 of study medication treatment	4 weeks

Secondary Outcome Measures

Name	Time	Method
GERD symptoms	4 weeks
Sleep disturbance	4 weeks
Use of antacid medications	4 weeks
Global assessment of GERD	4 weeks
Safety and tolerability assessments	4 weeks

Trial Locations

Locations (4)

71; 🇺🇸 Nashville, Tennessee, United States

62; 🇺🇸 Kansas City, Kansas, United States

54; 🇺🇸 Kansas City, Kansas, United States

73; 🇺🇸 Nashville, Tennessee, United States