Effect of Vecam 40/300 and Vecam 20/300 Compared to Omeprazole 20 mg on Gastric pH (NCT00818870) | Clinical Trial Compass
CompletedPhase 1
Effect of Vecam 40/300 and Vecam 20/300 Compared to Omeprazole 20 mg on Gastric pH
United States60 participantsStarted 2008-12
Plain-language summary
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.
Who can participate
Age range
18 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 o…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To assess whether Vecam 40/300 administered at bedtime w/o food is pharmacodynamically superior to Omeprazole 20 mg administered before breakfast, calculated as percent time gastric pH ≥4 for the 24-hour interval after the fifth dose.