CompletedNCT00810485Updated Jul 16, 2012

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

A Phase 2 interventional study of ADX10059 and ADX10059 in Gastroesophageal Reflux, sponsored by Addex Pharma S.A.. Completed at 40 sites in 5 countries. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2012-07-16.

Sponsored by Addex Pharma S.A. · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 298
Allocation: Randomized
Ages: 18 Years to 70 Years
Sex: All

Study 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

Conditions studied

Gastroesophageal Reflux

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Keywords

Gastroesophageal reflux
Proton pump inhibitor
Heartburn
Regurgitation

In context

Gastroesophageal Reflux

1,067 studies on the registry are indexed under Gastroesophageal Reflux; 188 are open to participants now.

This study's enrollment of 298 is above the median of 72 across 712 interventional studies indexed under Gastroesophageal Reflux.

Browse Gastroesophageal Reflux studies →

Lead sponsor

Addex Pharma S.A. is the lead sponsor of 7 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 70 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 298 participants (actual)

Study arms

Experimental
ADX10059 50 mg
twice-daily
Drug: ADX10059
Experimental
ADX10059 100 mg
twice-daily
Drug: ADX10059
Experimental
ADX10059 150 mg
twice-daily
Drug: ADX10059
Placebo comparator
ADX10059 Matching Placebo
twice-daily
Drug: ADX10059 Matching Placebo

Interventions

DrugADX10059
oral administration
DrugADX10059
oral administration
DrugADX10059
oral administration
DrugADX10059 Matching Placebo
oral administration

What researchers measure

Primary outcomes

Number of GERD symptom free days in week 4 of study medication treatment
Time frame: 4 weeks

Secondary outcomes

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

Study locations

40 sites

Little Rock, Arizona, United States
Tucson, Arizona, United States
Anaheim, California, United States
San Diego, California, United States
Colorado Springs, Colorado, United States
Jacksonville, Florida, United States
Port Orange, Florida, United States
Moline, Illinois, United States
54
Kansas City, Kansas, United States
62
Kansas City, Kansas, United States
Jackson, Mississippi, United States
Setauket, New York, United States
Harrisburg, North Carolina, United States
High Point, North Carolina, United States
Huntersville, North Carolina, United States
Raleigh, North Carolina, United States
Winston-Salem, North Carolina, United States
Fargo, North Dakota, United States
Cleveland, Ohio, United States
Oklahoma City, Oklahoma, United States
Philadelphia, Pennsylvania, United States
Charleston, South Carolina, United States
Germantown, Tennessee, United States
71
Nashville, Tennessee, United States
73
Nashville, Tennessee, United States
Baytown, Texas, United States
Houston, Texas, United States
Waukesha, Wisconsin, United States
Bordeaux, France
Colombes, France
Lyon, France
Nantes, France
Nice, France
Rouen, France
Dresden, Germany
Garmisch Partenkirchen, Germany
Magdeburg, Germany
Munich, Germany
Amsterdam, Netherlands
St Gallen, Switzerland

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 16, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00810485
Lead sponsor: Addex Pharma S.A.
Responsible party: Sponsor
First posted: Dec 18, 2008
Start date: Dec 2008
Primary completion: Dec 2009
Last update: Jul 16, 2012

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2012. You cannot join it, but the record below documents what was studied.

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Discussion

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