A Study to Evaluate the Efficacy and Safety of Arbaclofen Placarbil (XP19986) as Adjunctive Therapy in Subjects With Gastroesophageal Reflux Disease (GERD) - NCT00978016-53188 (Clinical Trial 331222)


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A Study to Evaluate the Efficacy and Safety of Arbaclofen Placarbil (XP19986) as Adjunctive Therapy in Subjects With Gastroesophageal Reflux Disease (GERD) - NCT00978016-53188 (Clinical Trial 331222)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy331222.aspx

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City:

Waukesha

State:

Zip Code:

53188

Conditions:

Gastroesophageal Reflux Disease

Purpose:

The purpose of the study is to evaluate efficacy and safety of arbaclofen placarbil (XP19986) versus placebo as adjunctive therapy in subjects with troublesome GERD symptoms despite therapy with approved doses of a Proton Pump Inhibitor (PPI).

Study summary:

Criteria:

Inclusion Criteria: 1. confirmed diagnosis of GERD by a gastroenterologist 2. minimum of 3 months of GERD symptoms prior to screening. 3. currently taking an FDA approved dose of PPI therapy for symptomatic GERD for at least 4 weeks prior to screening 4. experienced partial relief of GERD symptoms while receiving approved dose and regimen of PPI therapy 5. experienced GERD symptoms, defined as heartburn (with or without regurgitation or other GERD symptoms) on ≥ 3 days during the week prior to screening Exclusion Criteria: 1. evidence of erosive esophagitis or erosive gastritis on upper gastrointestinal endoscopy during screening 2. has not experienced any GERD symptom improvement after an adequate course of PPI treatment (at least 2 weeks) 3. unstable or severe medical condition

Study is available at:

Waukesha, WI 53188
United States

Primary Contact:

Phone: 910-558-2856

Secondary Contact:
Study Manager
Phone: 910-558-2856

If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.

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Data Source:

ClinicalTrials.gov

Date Processed:

November 17, 2009

Modifications to
this listing:

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Clinical trials are medical research studies designed to test the safety and/or effectiveness of new drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.


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