Clinical trial: Effectiveness of Physiologic Testing in PPI Non-Responders (NCT03202537)

Eligibility criteria:
Inclusion Criteria:

          -  Male or female subjects aged 18-80 years old (females of childbearing potential should
             be on highly effective contraceptive methods)

          -  Mentally capable to provide informed consent in English

          -  Present to the Northwestern Medical Group GI practice or the Washington University
             Division of Gastroenterology with symptoms of GERD (heartburn, regurgitation, and
             non-cardiac chest pain)

          -  Have failed an appropriate compliant trial of PPI therapy with a GERD-Q score ≥8.

          -  Able to undergo endoscopy, ambulatory reflux monitoring, manometry, PPI therapy
             cessation and trial of dexlansoprazole therapy. Subjects with Los Angeles
             Classification Grade A (mild) or B esophagitis and symptomatic, non-erosive disease
             will be enrolled.

        Exclusion Criteria:

          -  Participation in a concurrent clinical trial or completed another trial within past 8
             weeks.

          -  Active severe erosive esophagitis (Los Angeles Grade C or D), long-segment Barrett's
             esophagus (Zap score of 4)

          -  Eosinophilic esophagitis

          -  Prior gastrointestinal surgery of the esophagus and/or stomach

          -  Current treatment with dexlansoprazole

          -  Current signs or symptoms of heart disease. All patients with non-cardiac chest pain
             are required to have a cardiologist evaluation as standard of care work up in the
             evaluation of non-cardiac chest pain.

          -  Subjects with clinically abnormal results of the screening ECG and/or chemistry panel
             (particularly prolonged QTc interval or hypomagnesaemia) excluded from the
             dexlansoprazole trial. Subjects with sensitivities or allergies to the metals
             contained in the Bravo capsule including chromium, nickel, copper, cobalt, and iron.

          -  Unstable medical illness with ongoing diagnostic work-up and treatment. Patients with
             well-controlled hypertension, diabetes and a remote history of ischemic heart disease
             that is deemed stable, as judged by the investigator can be included.

          -  History of drug addiction, drug abuse or alcoholism.

          -  Current neurologic or cognitive impairment, which would preclude ability to obtain
             informed consent.

          -  Pregnant patients.

          -  Patients with Cirrhosis (Childs Classification A-C).Special vulnerable populations
             including children, prisoners, institutionalized individuals.

          -  Bleeding disorder or requirement of NSAID/aspirin during monitoring period.

          -  Drugs that affect gastrointestinal symptoms (H2 blockers, antacids, metoclopramide,
             domperidone, erythromycin, anticholinergics [bentyl, levsin, belladonna etc.]).
             Antidepressants can be continued at stable dose.

          -  Drugs listed on the Dexilant label including antiretrovirals (Rilpivirine-containing
             products, Atazanavir, Nelfinavir, Saquinavir, etc), Warfarin, Methotrexate, Drugs
             Dependent on Gastric pH for Absorption (e.g., iron salts, erlotinib, dasatinib,
             nilotinib, mycophenolate mofetil, ketoconazole/itraconazole), Tacrolimus, CYP2C19 or
             CYP3A4 Inducers or inhibitors.

          -  Patients found to have achalasia, a spastic disorder, hypercontractile disorder or
             functional obstruction at the esophagogastric junction will be excluded. Subjects with
             a history of structuring or narrowing upon endoscopy (Subjects with no such history
             will be enrolled; however, if such features are noted upon endoscopy during the study,
             these subjects will not undergo MI testing).
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.
Subject must be at most 80 Years

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? Contradiction