Clinical trial: A Study of Rabeprazole and Pantoprazole on Stomach Acid and Esophageal Acid Exposure in Patients With Gastroesophageal Reflux Disease (GERD) and a History of Nighttime Heartburn (NCT00237367)

Eligibility criteria:
Inclusion Criteria:

          -  Diagnosis of GERD with symptoms for at least 6 months with at least 3 episodes a week
             and one of those at nighttime

          -  in generally good health

          -  stop any previous similar (proton pump inhibitor) therapy at least 10 days before
             screening

          -  weigh within normal weight for one's height

          -  able to tolerate a nasogastric tube (pH probe assembly that goes through the nose into
             the stomach) for 48 hours on 2 different occasions

          -  esophageal acid exposure of at least 10% on a 24-hour pH monitoring study performed
             within the 24 months prior to screening

          -  Helicobacter pylori (an infection) negative

          -  willing to take only TUMS antacid as rescue medicine during the washout period

        Exclusion Criteria:

          -  History of a serious medical condition

          -  significant gastrointestinal illness other than GERD

          -  ulcer at any time in the past

          -  difficulty swallowing

          -  history of gastrointestinal disease (including bleeding)

          -  use of any medication that changes acid secretion or gastrointestinal movement in the
             past 14 days

          -  use of any drugs on a list of prohibited drugs within 1 month

          -  chronic use of pain relieving medications (NSAIDs or COX-2 inhibitors)

          -  pregnant or breast-feeding

          -  cancer diagnosis or treatment (except for superficial skin cancers)

          -  abusing drugs or alcohol
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 65 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? Entailment