Clinical Trial: A Comparative Study of KW-2246

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Phase III Study of KW-2246 (A Double Blind Study of KW-2246 Compared to Placebo for Breakthrough Pain Episodes in Cancer Patients)

Brief Summary: This is a placebo-controlled, double blind, comparative study to evaluate the efficacy and safety of KW-2246 as rescue medication at an optimal dose, which is determined by dose titration in treating breakthrough pain episodes in adult cancer patients receiving strong opioid analgesic on a fixed-schedule as well as rescue medication for breakthrough pain.

Detailed Summary:
Sponsor: Kyowa Hakko Kirin Co., Ltd

Current Primary Outcome: Pain intensity difference [ Time Frame: 30 minutes after each dose ]

Pain scores on the visual analog scale


Original Primary Outcome: Pain intensity difference

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Kyowa Hakko Kirin Co., Ltd

Dates:
Date Received: March 30, 2011
Date Started: March 2011
Date Completion:
Last Updated: March 6, 2017
Last Verified: March 2017