Clinical Studies, Section of Gastroenterology and Hepatology
Effect of Omeprazol Magnezium 20 mg (Prilosec OTC®) on Esophageal Healing in Non-erosive Frequent Heartburn
Principal Investigator: Roy C. Orlando, M.D.
Sponsor: Procter and Gamble
Status: Ongoing
Heartburn, a common medical symptom is the result of acid reflux into the esophagus and reflects the presence of broken epithelial barrier to acid access to the sensory nerve endings in the tissue. The aim of the study is to assess the ability of 2-weeks of omeprazole magnesium 20 mg (Prilosec OTC) to control symptoms and heal the microscopic esophageal damage in subjects with non- erosive esophagitis.
Mechanisms of Acid Resistance in Barrett’s Esophagus: Research Endoscopy and Biopsy
Principal Investigator: Roy C. Orlando, M.D
Sponsor: NIH
Status: Ongoing, collecting tissues
The aim of the study is to increase knowledge about the condition known as Barrett’s esophagus and its risk of cancer and any new information obtained will be provided to the medical community at large.
Esophageal Cytoprotection: Agents and Mechanisms
Principal Investigator: Roy C. Orlando, M.D.
Sponsor: NIH
Status: Ongoing, collecting tissues
The aim of the study is to learn more about the structure and function of normal and acid damaged esophageal epithelium. The study involves collecting esophageal tissue sample to evaluate the response to acid and other injury. The major benefit from this study is to increase knowledge about the esophagus and its various disease states.
Nonrandomized, Multicenter Study to Evaluate the Pharmacokinetics and Safety of Peginterferon Alpha-2a and Copegus™ Combination Therapy after Single and Multiple Doses in Patients with Chronic Hepatitis C and Moderate Renal Impairment, Severe Real Impairment and End-Stage renal Disease Undergoing Hemodialysis.
Principal Investigator: Virendra Joshi, M.D.
Sponsor: Hoffmann- LaRoche
Status: Enrollment closed, data analysis
The purpose of this study is to determine the safety, tolerability ( tendency of the drug to cause side effects), and pharmacokinetics of Peginterferon Alfa-2a and Copegus™ combination therapy after single and multiple doses in patients with hepatitis C and normal renal function, and patients with hepatitis C and kidney disease.
The Crohn’s Therapy, Resource, Evaluation and Assessment Tool [TREAT] Registry
Principal Investigator: Robert Bulat, M.D.
Sponsor: Centecor
Status: Ongoing
The TREAT Registry is an observational research initiative designed to document and assesses Crohn’s treatment strategies. Results from this Registry will be used to assist physicians in improving patient care with regard to clinical outcomes, economic consequences, and patient’ quality-of life.
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