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Therapeutic Areas: Gastroenterology
Disease Category: Gastroesophageal Reflux Disease (GERD)

Trial Information

A Dose-Response Efficacy and Safety Study of Arbaclofen Placarbil (XP19986) as Adjunctive Therapy in Subjects with Gastroesophageal Reflux Disease (GERD) who are Incomplete Responders to a Proton Pump Inhibitor (PPI).

This study is for men or women who are between the ages of 18 and 65, inclusive. Total patient participation is expected to last up to 11 weeks. This trial will consist of a screening/training period of 4 weeks, a treatment period of 6 weeks, and a follow-up period of 1 week. Subjects will be randomly assigned into one of the five treatment groups. Antacids will be provided as rescue medication during the treatment period. There are 10 office visits and subjects will be reimbursed $50 per completed visit. An Endoscopy will be performed between Visit 4 and Visit 5 and the subject will be reimbursed an additional $100 for having that procedure completed.

Patient Inclusion Criteria:

• Male or female aged 18 to 65 years, inclusive
• Diagnosed with GERD by a gastroenterologist
• Experiencing GERD symptoms for at least 3 months
• Stable on PPI therapy for at least 4 weeks with partial relief of GERD symptoms (will remain on this during the study and this medication will be provided at no cost)

Patient Exclusion Criteria:

• Nightshift employment (leads to irregular eating habits)
• Body Mass Index greater than 35 kg/m
• Has not experienced any GERD symptom improvement after PPI treatment
• Evidence of Erosive Esophagitis or Erosive Gastritis found during Endoscopy performed for screening
• Prior surgery of the upper GI tract, including Bariatric Surgery
• History of or current structural abnormality of the GI tract (e.g., Barrett's Esophagus, Esophageal Stricture, or Hiatal Hernia greater than 3 cm)
• Active duodenal or gastric ulcer
• Recurrent Pancreatitus or Cholecystitis
• Inflammatory Bowel Disease or Scleroderma
• Dysphagia
• Uncontrolled Arrhythmias, CHF or Unstable Angina
• Sleep Apnea
• COPD requiring Oxygen therapy or hospitalization in the last year
• Diabetes requiring insulin
• Fibromyalgia or other chronic pain disorders

Cheryl Nickles, Patient Recruitment Coordinator
Chase Medical Research, LLC
500 Chase Parkway, 3rd Floor
Waterbury, CT 06708
Phone: (203) 419-4404
Fax: (203) 465-7924
EMail: cnickles@chasemr.com

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