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A Trial of IW-3718 for 8 Weeks in Patients With Persistent Gastroesophageal Reflux Disease (GERD) Receiving Proton Pump Inhibitors (PPIs)
Trial ID: NCT03561090
The objective of this study is to evaluate the safety and efficacy of IW-3718 administered to patients with GERD who continue to have persistent symptoms, such as heartburn and regurgitation, while receiving once-daily (QD), standard-dose PPIs.
A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Trial of Oral IW-3718 Administered to Patients With Gastroesophageal Reflux Disease While Receiving Proton Pump Inhibitors
Each patient must meet all of the following criteria to be eligible for enrollment in this
- Patient is an ambulatory male or female (if female, nonpregnant) and is at least 18
years old at the Screening Visit.
- Patient has a diagnosis of GERD and reports experiencing GERD symptoms (heartburn or
regurgitation) while taking standard PPI therapy.
- Patient has evidence of pathological acid reflux.
- Female patients must not be pregnant and must agree to avoid pregnancy for the
duration of the study.
- Patient must comply with study procedures.
Patients who meet any of the following criteria will not be eligible to participate in the
- Patient has a history of complete lack of GERD symptom response to PPI therapy.
- Patient has a significant medical or surgical history including conditions that would
impact drug absorption or metabolism (such as bowel obstruction, poorly controlled
diabetes, gastroparesis, hiatal hernia).
- Patient reports pain or burning behind the breastbone or in the center of the upper
stomach as his or her predominant symptom at the Screening Visit.
- Patient has received an investigational drug during the 30 days before the Screening
Visit, or is planning to receive another investigational drug or use an
investigational device at any time during the study.
NOTE: Other inclusion and exclusion criteria apply, per the study protocol.
drug: Standard-dose PPIs QD