Clinical Research Studies

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

• Conditions:
  Gastroesophageal Reflux Disease
• Age: Between 18 years - 150 years
• Gender: Male or Female

• Other Inclusion Criteria:
  

  1. Patient has a diagnosis of GERD and reports experiencing GERD symptoms (heartburn or regurgitation) on average = 4 days per week over the last 8 weeks before the Screening Visit.
  2. Patient has been receiving standard-labeled dose, QD, PPI therapy (treatment that, according to the Investigator’s judgement, could not be further improved by changing the brand or timing of PPI administration) for a minimum of 8 weeks before the Screening Visit. Patients should be on a PPI dose and schedule that is consistent with the approved labeling. Patients who have their PPI modified during the Screening Period may be rescreened after 8 weeks of standard-labeled dose QD PPI therapy provided they have not previously entered the Pretreatment Period.
  3. Up to 96 hrs of pH monitoring (with a Bravo device) during the Screening Period (while the patient continues taking their PPI) demonstrates evidence of a pathological acid reflux (pH is <4 for = 4.2% of the recording time) during at least 1 of the 24-hour time intervals of pH testing with the Bravo device as confirmed by centralized review of pH monitoring.
  4. Patient agrees not to make any changes to their usual diet or exercise regimen during the study.

  
  

You may not be eligible for this study if the following are true:

• 1. Patient reports epigastric pain or epigastric burning as his or her predominant symptom at the Screening Visit.
  2. Patient has a diagnosis of gastroparesis per gastric emptying study, or a history of bowel obstruction, or is at risk for a bowel obstruction (e.g. patient has an organic gastrointestinal [GI] motility disorders or a history of major GI surgery.
  3. Patient has an active swallowing disorder that would compromise their ability to swallow the study medication.
  4. Patient has undergone surgery that meets any of the following criteria: a)Surgery of the GI tract (including gastric banding) other than an appendectomy, cholecystectomy, minor oral or rectal surgery (e.g., tonsillectomy, hemorrhoidectomy, rectocele repair) at any time before the Screening Visit.
  5. Patient has a history of cancer (resected basal cell or squamous cell carcinoma is acceptable).