drugset / Trial / NCT01606124

Polyphenon E in Treating Patients With High-Risk of Colorectal Cancer

NCT01606124 ↗

RandomizedParallel-groupDouble-blindTreatment

Summary

This phase II trial studies how well Polyphenon E works in treating patients with high-risk of colorectal cancer. Polyphenon E contains ingredients that may prevent or slow colorectal cancer.

Timeline

Start
2012-06
Primary completion
2015-05-21
Completion
2015-05-21

Outcome

Missed primary endpoint

Stopped: “pending expiration of the supply of study agent.”

registry analysis (superiority test); Arm I (Polyphenon E) vs Arm II (Placebo); p = 0.5631; Wilcoxon (Mann-Whitney) NCT01606124 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Sinecatechins Unknown 400 mg Oral