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CompletedNCT00818870Updated Jan 27, 2010

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

A Phase 1 interventional study of Omeprazole and Vecam in Gastroesophageal Reflux, sponsored by Vecta Ltd.. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-01-27.

Sponsored by Vecta Ltd. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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.

Read the detailed description

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.

02

Conditions studied

  • Gastroesophageal Reflux

Keywords

  • Gastroesophageal Reflux
  • GERD
  • Nocturnal GERD
  • Heartburn
  • Nighttime Heartburn
  • Nocturnal Heartburn
03

In context

Gastroesophageal Reflux

1,067 studies on the registry are indexed under Gastroesophageal Reflux; 188 are open to participants now.

This study's planned enrollment of 60 is below the median of 72 across 712 interventional studies indexed under Gastroesophageal Reflux.

Browse Gastroesophageal Reflux studies →

Lead sponsor

Vecta Ltd. is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Active comparator
    Omeprazole 20 mg

    Drug: Omeprazole

  • Experimental
    Vecam 20/300

    Drug: Vecam

  • Experimental
    Vecam 40/300

    Drug: Vecam

Interventions

  • DrugOmeprazole

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

  • DrugVecam

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

  • DrugVecam

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

06

What researchers measure

Primary outcomes

  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.

    Time frame: 5 days

Secondary outcomes

  1. To assess whether Vecam 40/300 administered at bedtime w/o food is pharmacodynamically superior to Vecam 20/300 administered at bedtime w/o food calculated as percent time gastric pH ≥4 for the 24-hour interval after the fifth dose.

    Time frame: 5 days

  2. To assess whether Vecam 20/300 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.

    Time frame: 5 days

  3. To assess whether Vecam 40/300 administered at bedtime w/o food is pharmacodynamically superior to Vecam 20/300 administered at bedtime w/o food calculated as percent time gastric pH ≥4 during nocturnal hours after the fifth dose.

    Time frame: 5 days

  4. 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 during nocturnal hours after the fifth dose

    Time frame: 5 days

  5. To assess whether Vecam 20/300 administered at bedtime w/o food is pharmacodynamically superior to Omeprazole 20 mg administered before breakfast calculated as percent time gastric pH ≥4 during nocturnal hours after the fifth dose.

    Time frame: 5 days

  6. To asses Vecam 40/300 administered at bedtime w/o food vs. Omeprazole 20 mg administered before breakfast calculated as percent time pH ≥4 during 24-hour interval and nocturnal hours at early dosing days.

    Time frame: 5 days

  7. To assess the safety of Vecam 40/300 and Vecam 20/300 administered at bedtime vs. Omeprazole 20 mg administered before breakfast during treatment period.

    Time frame: 5 days

07

Study locations

1 site
  • Clinical Applications Laboratories Inc.
    San Diego, California 92103, United States
08

References and documents

Publications

  • Chowers Y, Atarot T, Pratha VS, Fass R. The effect of once daily omeprazole and succinic acid (VECAM) vs once daily omeprazole on 24-h intragastric pH. Neurogastroenterol Motil. 2012 May;24(5):426-31, e208-9. doi: 10.1111/j.1365-2982.2012.01884.x. Epub 2012 Feb 28. PubMed 22372795 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 27, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00818870
Lead sponsor
Vecta Ltd.
First posted
Jan 8, 2009
Start date
Dec 2008
Primary completion
Jun 2009
Completion
Jun 2009
Last update
Jan 27, 2010

Study contacts

Vijayalakshmi S Pratha, MD
principal investigator · Clinical Applications Laboratories Inc.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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