Clinical trial: Trial of IW-3718 for 8 Weeks in Patients With Persistent Gastroesophageal Reflux Disease (GERD) Receiving Proton Pump Inhibitors (NCT03561883)

Eligibility criteria:
Inclusion Criteria:

        Each patient must meet all of the following criteria to be eligible for enrollment in this
        study:

          -  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 proton pump inhibitor (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
        study:

          -  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.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): A 48-year-old man comes to the office complaining of heartburn and acid reflux.  He has taken over-the-counter antacids but sees no relief.  Other medical history is unremarkable.  The patient does not use tobacco, alcohol, or illicit drugs.  Vital signs are within normal limits.  BMI is 31 kg/m2.  Physical examination is  positive for mild tenderness in upper stomach. Chest x-ray shows an air-fluid opacity behind the heart.  A barium swallow study reveals approximately 1/3 of the stomach herniating through the esophageal hiatus.

Patient description (patient's own words): I went to my doctor's office because of a non-stop heartburn and some acid reflux. I took over-the-counter medications, but it keeps going strong! I don't smoke, take drugs or drink alcohol, I'm healthy! The doctor took my vitals, which turned out normal. My BMI is 31, which might be a bit too much for a 48-year-old guy like me. They examined my stomach and found a mild tenderness in the upper part. I also did some X-rays, and they found out that I have an air-fluid opacity behind my heart. I did another X-ray, and it turns out that a part of my stomach went up my chest through a hole in my diaphragm!

Does the patient match the trial criteria? Entailment