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

Completed · Phase 2 · Has a placebo group

Conditions studied: Gastroesophageal Reflux

In brief

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

Key facts

Study ID

NCT00810485

Run by

Addex Pharma S.A.

People needed

298

Starts

2008-12-01

Last updated by the study team

2012-07-16

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• diagnosis of typical GERD
• partial responder to a stable standard clinical symptoms control dose of PPI therapy
• body mass index ≤ 32 kg/m2

You may not qualify if…

• 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

Where it is running

• Study site — Little Rock, Arizona, United States
• Study site — Tucson, Arizona, United States
• Study site — Anaheim, California, United States
• Study site — San Diego, California, United States
• Study site — Colorado Springs, Colorado, United States
• Study site — Jacksonville, Florida, United States
• Study site — Port Orange, Florida, United States
• Study site — Moline, Illinois, United States
• 54 — Kansas City, Kansas, United States
• 62 — Kansas City, Kansas, United States
• Study site — Jackson, Mississippi, United States
• Study site — Setauket, New York, United States
• Study site — Harrisburg, North Carolina, United States
• Study site — High Point, North Carolina, United States
• Study site — Huntersville, North Carolina, United States
• Study site — Raleigh, North Carolina, United States
• Study site — Winston-Salem, North Carolina, United States
• Study site — Fargo, North Dakota, United States
• Study site — Cleveland, Ohio, United States
• Study site — Oklahoma City, Oklahoma, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Charleston, South Carolina, United States
• Study site — Germantown, Tennessee, United States
• 71 — Nashville, Tennessee, United States
• 73 — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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