Clinical trial: Impact of Timing on the Efficacy of Zegerid 40 mg in Healing Reflux Esophagitis: A Pilot Study (NCT00693225)

Eligibility criteria:
Inclusion Criteria:

          1. Subjects who have either moderate to severe erosive esophagitis (Los Angeles grade C
             or D)

          2. Subjects with esophagitis despite use of a non-omeprazole Proton Pump Inhibitor
             (PPI)(s) or histamine receptor antagonist (HRA) were invited to participate without a
             wash-out period.

          3. Subjects able to return to Mayo Clinic Rochester for follow up endoscopy 8 weeks after
             start of study.

          4. Female subjects are eligible if they are not pregnant or lactating and one of the
             following criteria is met:

               1. Surgically sterile (by means of hysterectomy or bilateral tubal ligation).

               2. At least one year postmenopausal (no menses for greater than or equal to 12
                  months).

               3. Subject is using a highly effective method of contraception, if of childbearing
                  potential and has a negative urine human chorionic gonadotropin beta subunit
                  (B-HCG) pregnancy test during screening, and prior to trial drug administration.

        Exclusion Criteria:

          1. Subjects already on or failed omeprazole in past, or intolerant of PPI therapy

          2. Subjects who are using clopidogrel (Plavix)

          3. Subjects with one or more of the following diagnoses:

               1. Neoplasm of the esophagus or stomach

               2. Previous upper gastrointestinal surgery (esophagectomy, Heller myotomy, hiatal
                  hernial repair)

               3. Diabetic gastroparesis

               4. Esophageal motility disorder: Achalasia or scleroderma

               5. Zollinger-Ellison syndrome

               6. Infection with human immunodeficiency virus (HIV)

               7. Bleeding diathesis

               8. History of gastric or small bowel obstruction

               9. Inability to read due to blindness, cognitive dysfunction, English language
                  illiteracy

              10. Disorders which predispose to unreliable responses such as Schizophrenia,
                  Alzheimer's disease or significant memory loss

              11. Pregnant and lactating females will be excluded as PPIs are not thought safe for
                  the fetus (Pregnancy Category C).

          4. Children younger than 18 years of age will be excluded as their compliance might be
             dictated by others, such as their parents, and their results would not be
             generalizable to the adult population. Other vulnerable populations, such as those
             with diminished mental acuity, will be excluded for the same reason.

          5. Residence outside of the US (due to difficulties with overseas postal service) or in
             prison.
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? Contradiction