Effect of Vecam 40/300 and Vecam 20/300 Compared to Omeprazole 20 mg on Gastric pH

Completed · Phase 1

Conditions studied: Gastroesophageal Reflux

In brief

The study is designed to assess and compare the effect of Vecam 40/300, Vecam 20/300 and Omeprazole 20 mg (a standard FDA approved GERD treatment) on the control of gastric pH.

Key facts

Study ID

NCT00818870

Run by

Vecta Ltd.

People needed

60

Starts

2008-12-01

Expected to finish

2009-06-01

Last updated by the study team

2010-01-27

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Clinical Applications Laboratories Inc. — San Diego, California, United States

Full record on ClinicalTrials.gov

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