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

NCT00818870 | Completed Phase 1

• 1 other identifier: VCT006
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastroesophageal Reflux

Keywords

Gastroesophageal Reflux; GERD; Nocturnal GERD; Heartburn; Nighttime Heartburn; Nocturnal Heartburn

Outcome Measures

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.

  5 days

Secondary Outcomes (7)

• 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.

  5 days

• 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.

  5 days

• 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.

  5 days

• 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

  5 days

• 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.

  5 days

Study Arms (3)

Omeprazole 20 mg

ACTIVE COMPARATOR

Drug: Omeprazole

Vecam 20/300

EXPERIMENTAL

Drug: Vecam

Vecam 40/300

EXPERIMENTAL

Drug: Vecam

Interventions

Omeprazole DRUG

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

Omeprazole 20 mg

Vecam DRUG

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

Vecam 20/300

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vecta Ltd.: lead

Study Sites (1)

Clinical Applications Laboratories Inc.

San Diego, California, 92103, United States

Location

Related Publications (1)

• 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.

  PMID: 22372795 DERIVED

MeSH Terms

Conditions

Gastroesophageal Reflux; Heartburn

Interventions

Omeprazole

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Vijayalakshmi S Pratha, MD

  Clinical Applications Laboratories Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 6, 2009
• First Posted: January 8, 2009
• Study Start: December 1, 2008
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: January 27, 2010

Record last verified: 2010-01

Locations

US (1)