Clinical Trial: Efficacy and Safety of Fentanyl ETHYPHARM for Breakthrough Pain in Opioid-treated Patients With Cancer

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

Official Title: Randomized, Placebo-controlled Study of Fentanyl ETHYPHARM for Breakthrough Pain in Opioid-treated Patients With Cancer

Brief Summary: The purpose of the study is to assess the clinical effectiveness of Fentanyl ETHYPHARM when used to relieve breakthrough pain (BTP) in opioid-treated cancer patients.

Detailed Summary:
Sponsor: Ethypharm

Current Primary Outcome: Summed Pain Intensity Difference at 30 minutes (SPID30). [ Time Frame: 30 minutes post dose ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • SPID at 3, 6, 10, 15 and 60 minutes post-dosing [ Time Frame: 3, 6, 10, 15 and 60 minutes post-dosing ]
  • SPID at 15 and 30 minutes according to the pathophysiology of the pain (neuropathic, nociceptive) [ Time Frame: 15 and 30 minutes post dose ]
  • Pain Intensity Difference at 3, 6, 10, 15, 30 and 60 minutes after dosing [ Time Frame: 3, 6, 10, 15, 30 and 60 minutes after dosing ]
  • Pain Relief at 3, 6, 10, 15, 30 and 60 minutes after dosing [ Time Frame: 3, 6, 10, 15, 30 and 60 minutes after dosing ]
  • The proportion of episodes of BTP that required rescue medication [ Time Frame: 15 and 30 minutes post dose ]
  • the proportion of episodes with more than 33% and 50% of improvement in Pain Intensity scores [ Time Frame: 15 and 30 minutes post dose ]
  • Recording of safety data [ Time Frame: During all the study duration, an expected average of 8 weeks ]
    Adverse events, vital signs, urinary pregnancy test


Original Secondary Outcome: Same as current

Information By: Ethypharm

Dates:
Date Received: April 18, 2013
Date Started: November 2011
Date Completion:
Last Updated: May 2, 2013
Last Verified: April 2013