Clinical trial: Can E-cadherin Found in Tissue/Blood be Valuable in Identifying & Monitoring Patients With Post-proton Pump Inhibitor (PPI)-Responsive Heartburn (NCT01149395)

Eligibility criteria:
Inclusion Criteria: (all responses must be Yes)

          -  Between 18 and 75 years of age

          -  Male or non-pregnant, non-lactating female

          -  Willing and able to undergo endoscopy with biopsies and a blood draw

          -  Willing and able to discontinue use of PPIs for at least 1 month prior to the study
             start date

          -  Endoscopy-negative heartburn of moderate severity at least 3 times-a-week for 3 months

        Exclusion Criteria:(all responses must be No)

          -  History of:

               -  Barrett's Esophagus

               -  Erosive Esophagus

               -  Zollinger Ellison syndrome

               -  bleeding disorder

               -  upper gastrointestinal bleeding or malignancy

               -  esophageal motor disorder

               -  esophageal stricture

               -  esophageal varices

          -  Had the following surgeries:

               -  organ transplant

               -  gastric or esophageal surgery for the treatment of: Esophageal Cancer, Achalasia,
                  Gastroesophageal Reflux Disease (GERD); i.e. Nissen Fundoplication

          -  Have any of the following:

               -  Current malabsorption

               -  inflammatory bowel disease

               -  severe heart-lung-liver or renal cerebrovascular disease

               -  known hypersensitivity to PPIs

          -  Currently taking any of the following medications:

               -  Quinidine

               -  quinine

               -  benzodiazepines

               -  antineoplastic agents

               -  dilantin

               -  warfarin

               -  non-steroidal anti-inflammatory drugs

               -  narcotics

               -  prostaglandins

               -  salicylates (except baby aspirin for cardiovascular protection)

               -  H2-receptor antagonists

               -  PPIs other than study agent

               -  steroids

               -  promotability drugs

               -  sucralfate

               -  KCl

               -  anti-tuberculosis medication

               -  oral biphosphonates

               -  drugs requiring acid for absorption (iron, ampicillin, digoxin and ketoconazole)
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 75 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