Clinical Trial: YF476 in Barrett's Esophagus

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional

Official Title: Randomized, Placebo-controlled Trial of YF476, a Gastrin Receptor Antagonist, in Barrett's Esophagus

Brief Summary: A phase 2, randomised, double-blind, out-patient trial to determine if YF476 is a safe and effective treatment in patients with Barrett's esophagus.

Detailed Summary:
Sponsor: Trio Medicines Ltd.

Current Primary Outcome: Decrease in Ki67 biomarker expression [ Time Frame: Periodically for 12 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Measure the abundance esophageal adenocarcinoma biomarkers [ Time Frame: Periodically for 12 weeks ]
  To assess the effects of YF476 on biomarkers associated with esophageal adenocarcinoma, in particular, cyclooxygenase-2 (COX-2), p53, CCK2R and DCAMKL1.
• Measure the abundance of biomarkers of gastric acid suppression and ECL cell hyperplasia [ Time Frame: Periodically for 12 weeks ]
  To assess the effects of YF476 on fasting serum gastrin, a marker of gastric acid suppression, and plasma chromogranin A (CgA), a marker of ECL cell hyperplasia.
• Adverse events in subjects [ Time Frame: Periodically for 12 weeks ]
  To determine whether YF476 is safe in patients with Barrett's esophagus by measuring the incidence of adverse events.

Original Secondary Outcome: Same as current

Information By: Trio Medicines Ltd.

Dates:
Date Received: June 3, 2015
Date Started: June 2013
Date Completion: December 2016
Last Updated: April 20, 2016
Last Verified: April 2016