Clinical trial: Effect of Vecam 40/300 and Vecam 20/300 Compared to Omeprazole 20 mg on Gastric pH (NCT00818870)

Eligibility criteria:
Inclusion Criteria:

          -  Healthy, H. pylori negative status (by Urea Breath Test)

          -  Male or female subjects

          -  Age 18-55 years

          -  Able to tolerate the placement of a nasogastric pH probe at screening

          -  Baseline Gastric pH≤2

          -  Use of acceptable form of birth control in females with child-bearing potential

          -  Had not used any form of tobacco (e.g. smoking or chewing) for the last year

          -  Can swallow a size "00" capsule without difficulty

          -  Willing to comply with study protocol

          -  Signed Informed Consent form

        Exclusion Criteria:

          -  BMI > 40

          -  Slow or poor Omeprazole metabolizers (heterozygous or homozygous, respectively) based
             on CYP2C19 genotyping test.

          -  Any significant history of / or concurrent gastrointestinal diseases or conditions
             such as:

               -  GERD

               -  Acute gastrointestinal bleeding

               -  Zollinger Ellison Syndrome or Gastric hypersecretory condition

               -  Known Barrett's esophagus

               -  Esophageal stricture

               -  Peptic ulcer disease (gastric or duodenal) or family history of peptic ulcer
                  disease

               -  Gastric outlet obstruction

               -  Gastroparesis

          -  Significant medical history or concurrent illness as determined by the principal
             investigator

          -  Any medical disorder that alters the normal gastric acid secretion profile as
             determined by the principal investigator

          -  History of diabetes mellitus

          -  Significant laboratory abnormalities as determined by the principal investigator

          -  Known metabolic alkalosis, hypocalcemia, sodium restricted diet, hypokalemia,
             respiratory alkalosis

          -  Pregnant or lactating women

          -  Had been treated with any investigational drug or therapy or participated in a
             clinical trial within 30 days prior to entering the trial

          -  Use of any medication other than contraception or hormone replacement therapy; OTC
             drugs other than vitamins or occasional acetaminophen within 30 days prior to entering
             the trial or during the trial

          -  Use of NSAID medications within 30 days prior to entering the trial (e.g. Ibuprofen,
             Aspirin, Naproxen etc)

          -  Positive urine test for alcohol or other drugs

          -  Concurrent use of gastric anti-secretory drugs such as defined below:

               -  Use of a PPI 30 days prior to each stage or during the trial

               -  Use of H2RA 14 days prior to each stage or during the trial

               -  Concurrent use of antacids (including over-the-counter) 24 hours prior to each
                  stage or during the trial

          -  Use of any medication that modifies gastric acid secretion 30 days prior to or during
             the trial.

          -  Had ingested grapefruit within 14 days of dose administration in any trial period

          -  Significant drug allergy or known hypersensitivity to any of the ingredients in the
             trial drugs Omeprazole, Succinic Acid or to Lidocaine

          -  Consumption of coffee within 48 hours of dose administration in any trial period.

          -  Had donated blood within 30 days of entering the trial

          -  Known positive serology for HBV, HCV or HIV

          -  Any reason which makes the subject a poor candidate based on the physician's
             discretion
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 55 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