This study was conducted to determine the safety and efficacy of the green tea-derived Polyphenon E (Poly E) in @entity1 with @entity355 ( @entity355 ). Subjects were randomized to a 6-month, twice daily (BID) oral treatment of placebo or Poly E (200, 400, or 600 mg). Endoscopic evaluation, including biopsies, was performed before and after treatment. The primary objective was to demonstrate safety; secondary objectives investigated @entity12919 accumulation and effects in clinical specimens. Of the 44 enrolled subjects, 11 received placebo, and 33 received Poly E. No dose-limiting @entity137 were encountered, and a maximum tolerated dose (MTD) was not reached. The recommended phase II dose was 600 mg twice daily. The most common treatment-related adverse events (AE) in Poly E-treated subjects were grade I and II @entity390 , grade I belching, and grade I @entity880 dehydrogenase (LDH) elevation. No treatment-related AEs were reported in placebo-treated subjects, aside from grade I @entity854 . Pill counts and subject diaries were not consistently collected, and compliance was difficult to determine. However, on the basis of an intention-to-treat analysis, there was a significant relationship between Poly E dose and esophageal @entity3090 level--mean changes (pmol/g) of 0.79 (placebo), 6.06 (200 mg), 35.67 (400 mg), and 34.95 (600 mg); P = 0.005. There was a possible relationship between Poly E dose and urine @entity18313 concentration. In conclusion, Poly E was well-tolerated, and treatment with Poly E (400 and 600 mg) but not Poly E (200 mg) or placebo resulted in clinically relevant and detectable @entity3090 accumulation in the target organ, esophageal mucosa.

Phase Ib Randomized, Double-Blinded, Placebo-Controlled, Dose Escalation Study of Polyphenon E in XXXX with @entity355 .

@entity1 :: ('9606', 'Species') :: ['patients'] @entity137 :: ('MESH:D064420', 'Disease') :: ['toxicities'] @entity390 :: ('MESH:D009325', 'Disease') :: ['nausea'] @entity355 :: ('MESH:D001471', 'Disease') :: ["Barrett's Esophagus", 'BE'] @entity12919 :: ('MESH:D002392', 'Chemical') :: ['catechin'] @entity3090 :: ('CHEBI:4806', 'Chemical') :: ['EGCG'] @entity18313 :: ('MESH:C060526', 'Chemical') :: ['PGE-M'] @entity854 :: ('MESH:D018376', 'Disease') :: ['laboratory abnormalities'] @entity880 :: ('MESH:D019344', 'Chemical') :: ['lactate']
@entity1 :: (9606,Species) :: ['Patients']
