Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Indivior Inc.
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. History of GERD symptoms (e.g. heartburn episodes) at least 3 times per week
2. Discontinuation of drugs used to treat GERD (PPIs, H2-blockers) and/or drugs known to cause GERD symptoms (e.g. nonsteroidal anti-inflammatory drugs \[NSAIDs\]) for 7 days prior to baseline (Visit 2);
3. Had greater then or equal to 20 postprandial reflux episodes/2 hours recorded using impedance/pH monitoring during Screening/Baseline period (Visit 2)
You may not be if
1. History of gastrointestinal disorders other than GERD that may have significantly affected the assessment of reflux episodes or GERD symptoms (e.g. Barrett's Esophagus, active gastric or duodenal ulcer disease, achalasia, scleroderma, etc.).
2. Medical conditions that could have affected assessments of reflux episodes or GERD symptoms (e.g. history of nausea and/or vomiting, neurologic/psychiatric disorders, cardiac disease \[e.g. angina\], lung disease \[e.g. asthma, cough\], etc.)
Clareo Health | A Study to Evaluate the Efficacy and Safety of Controlled Release Arbaclofen Placarbil (XP19986) in Patients With Gastroesophageal Reflux Disease
