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

NCT ID: NCT00818870

Last Updated: 2010-01-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-12-31
• Study Completion Date: 2009-06-30

Brief 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.

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.

Conditions

Gastroesophageal Reflux

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Omeprazole 20 mg

Group Type: ACTIVE_COMPARATOR

Omeprazole

Intervention Type: DRUG

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

Vecam 20/300

Group Type: EXPERIMENTAL

Vecam

Intervention Type: DRUG

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

Vecam 40/300

Group Type: EXPERIMENTAL

Vecam

Intervention Type: DRUG

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

Interventions

Omeprazole

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

Intervention Type: DRUG

Vecam

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

Intervention Type: DRUG

Vecam

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Vecta Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Vecta

Principal Investigators

Vijayalakshmi S Pratha, MD

Role: PRINCIPAL_INVESTIGATOR

Clinical Applications Laboratories Inc.

Locations

Clinical Applications Laboratories Inc.

San Diego, California, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 22372795 (View on PubMed)

Other Identifiers

VCT006

Identifier Type: -

Identifier Source: org_study_id