Title

Effect of Vecam 40/300 and Vecam 20/300 Compared to Omeprazole 20 mg on Gastric pH
A Randomized, Open-Label, Cross-Over, Dose-Ranging Study to Assess the Effect of Vecam 40/300 and Vecam 20/300 Administered at Bedtime Compared to Omeprazole 20 mg Administered Before Breakfast on Gastric pH
  • Phase

    Phase 1
  • Study Type

    Interventional
  • Status

    Completed No Results Posted
  • Study Participants

    60
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.
Eligible H. pylori negative, normal gastric acid secreting, healthy volunteers will be treated by the study medications in a randomized, open-label, cross-over study.Up to 60 volunteers may be enrolled to ensure that at least 30 subjects will complete all the study treatments. Omeprazole 20 mg will be administered before breakfast. Vecam 40/300 and Vecam 20/300 will be administered at bedtime w/o food. 24-hour gastric pH will be measured after the fifth dose (day 5).Following screening procedures, subjects will be randomly assigned to receive the different treatments.

All pH measurements will be done in the study center under supervised conditions. All drug administrations will be supervised.

This study is part of the Vecam clinical development plan.
Study Started
Dec 31
2008
Primary Completion
Jun 30
2009
Study Completion
Jun 30
2009
Last Update
Jan 27
2010
Estimate

Drug Omeprazole

20 mg capsule, orally, once daily (before breakfast) for 5 days.

Drug Vecam

1 capsule, orally, once daily at bedtime for 5 days.

Drug Vecam

1 capsule, orally, once daily at bedtime for 5 days.

Omeprazole 20 mg Active Comparator

Vecam 20/300 Experimental

Vecam 40/300 Experimental

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 Results Posted