Effect of Vecam 40/300 and Vecam 20/300 Compared to Omeprazole 20 mg on Gastric pH - Full Text View

Sponsored by:	Vecta Ltd.
Information provided by:	Vecta Ltd.
ClinicalTrials.gov Identifier:	NCT00818870

Purpose

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.

Condition	Intervention	Phase
Gastroesophageal Reflux	Drug: Omeprazole Drug: Vecam	Phase I

MedlinePlus related topics: GERD Heartburn

Drug Information available for: Esomeprazole magnesium Esomeprazole Sodium Omeprazole Omeprazole magnesium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Pharmacodynamics Study
Official Title:	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

Further study details as provided by Vecta Ltd.:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	December 2008
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Omeprazole 20 mg: Active Comparator	Drug: Omeprazole 20 mg capsule, orally, once daily (before breakfast) for 5 days.
Vecam 20/300: Experimental	Drug: Vecam 1 capsule, orally, once daily at bedtime for 5 days.
Vecam 40/300: Experimental	Drug: Vecam 1 capsule, orally, once daily at bedtime for 5 days.

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.

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00818870

Locations

United States, California
Clinical Applications Laboratories Inc.	Recruiting
San Diego, California, United States, 92103
Contact: Vijayalakshmi S Pratha, MD 619-260-1012

Sponsors and Collaborators

Vecta Ltd.

Investigators

Principal Investigator:

Vijayalakshmi S Pratha, MD

Clinical Applications Laboratories Inc.

More Information

Vecta Ltd. home page This link exits the ClinicalTrials.gov site

Responsible Party:	Vecta ( Richard E. Lowenthal )
Study ID Numbers:	VCT006
Study First Received:	January 6, 2009
Last Updated:	January 6, 2009
ClinicalTrials.gov Identifier:	NCT00818870
Health Authority:	United States: Food and Drug Administration

Keywords provided by Vecta Ltd.:

Gastroesophageal Reflux
GERD
Nocturnal GERD

Heartburn
Nighttime Heartburn
Nocturnal Heartburn

Study placed in the following topic categories:

Deglutition Disorders
Esophageal Motility Disorders
Pyrosis
Digestive System Diseases
Esophageal disorder

Gastrointestinal Diseases
Heartburn
Omeprazole
Esophageal Diseases
Gastroesophageal Reflux

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Anti-Ulcer Agents

Gastrointestinal Agents
Enzyme Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009