Trial of a Gastrin Receptor Antagonist in Barrett's Esophagus
The purpose of this study is to determine whether treatment with an experimental drug called YF476 in patients with Barrett's esophagus reduces the expression of tissue markers that are associated with an increased risk of developing esophageal cancer.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Randomized Placebo-Controlled Trial of YF476, a Gastrin Receptor Antagonist, in Barrett's Esophagus|
- Cellular proliferation [ Time Frame: Up to 3 months from baseline ] [ Designated as safety issue: No ]
- Changes in biomarker expression [ Time Frame: Up to 3 months from baseline ] [ Designated as safety issue: No ]
- Number of participants with adverse events (any adverse events and/or severe adverse events) as a measure of safety and tolerability. [ Time Frame: Up to 4 weeks after completion of study drug ] [ Designated as safety issue: Yes ]
|Study Start Date:||November 2012|
|Estimated Study Completion Date:||April 2016|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
YF476 (gastrin-receptor antagonist)
Subjects will take YF476, 25 mg capsules, once daily, for three months.
Placebo Comparator: Placebo
Placebo pill (identical in appearance to YF476 pills)
Subjects will take placebo pill (identical in appearance to YF476 pills) once daily for 3 months.
The association between gastro-esophageal reflux disease (GERD) and cancer of the esophagus is well-established. Barrett's esophagus (BE) is a condition in which the lining of the part of the esophagus changes to look like small intestine, and this change occurs in the setting of GERD. Patients with BE are at increased risk for developing esophageal cancer. It is recommended that all patients with BE take medicines called proton pump inhibitors (PPIs), which greatly reduce the acid produced by the stomach, in the hopes of reducing the risk of esophageal cancer. However, by reducing the acid level in the stomach, levels of a hormone called gastrin are increased. There is laboratory data to suggest that gastrin may have effects that actually promote the development of cancer, including esophageal cancer. The investigators previously showed that BE patients with very high gastrin levels are more likely to have either advanced precancerous changes (also called high grade dysplasia) or cancer of the esophagus. As such, the obvious question is raised: does gastrin promote the development of cancer in BE? YF476 is a new drug that blocks the effects of gastrin. Trials in healthy subjects have demonstrated that the drug is safe and well-tolerated. The investigators therefore propose to conduct a randomized placebo-controlled trial of YF476 in patients with Barrett's esophagus. The primary hypothesis is that treatment with YF476 will reduce the expression of tissue markers that are associated with an increased risk of developing esophageal cancer.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01298999
|Contact: Adriana Rodriguezfirstname.lastname@example.org|
|United States, New York|
|New York Presbyterian Hospital - Columbia||Recruiting|
|New York, New York, United States, 10032|
|Contact: Adriana Rodriguez 212-304-5606 email@example.com|
|Principal Investigator:||Julian A Abrams, MD, MS||Columbia University|