A Trial of IW-3718 for 8 Weeks in Patients With Persistent Gastroesophageal Reflux Disease (GERD) Receiving Proton Pump Inhibitors (PPIs)


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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.

Official Title

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

Stanford Investigator(s)

John Clarke
John Clarke

Clinical Professor, Medicine - Gastroenterology & Hepatology


Inclusion Criteria:

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.

Exclusion Criteria:

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: IW-3718

drug: placebo

drug: Standard-dose PPIs QD


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Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Divya Pathak