Clinical Trial: Efficacy/Safety Study of ACTIQ® for Opioid-Tolerant Children and Adolescents With Breakthrough Pain (BTP)

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

Official Title: A Double-Blind, Placebo-Comparison Study to Evaluate the Efficacy and Safety of ACTIQ® (Oral Transmucosal Fentanyl Citrate [OTFC®]) Treatment for Opioid-Tolerant Children and Adolescents Wit

Brief Summary: The primary objective of the study is to evaluate the efficacy of ACTIQ treatment for the management of breakthrough pain (BTP) compared to placebo treatment in children with cancer and non-cancer pain who are receiving around-the-clock (ATC) opioid therapy and who require additional therapy for BTP episodes. This will be determined by the analysis of the pain intensity (PI), measured by the Faces Pain Scale-Revised (FPS-R) administered 15 minutes after the start of each unit of study drug with an optimal ACTIQ dosage.

Detailed Summary:

The primary objective of the study is to evaluate the efficacy of ACTIQ treatment for the management of breakthrough pain (BTP) compared to placebo treatment in children with pain who are receiving around-the-clock (ATC) opioid therapy and who require additional therapy for BTP episodes. This will be determined by the analysis of the pain intensity (PI), measured by the Faces Pain Scale-Revised (FPS-R) administered 15 minutes after the start of each unit of study drug with an optimal ACTIQ dosage.

The secondary objectives are:

  • to evaluate the characteristics of BTP in children with pain, including their response to treatment
  • to evaluate the efficacy of ACTIQ treatment compared to placebo treatment for these children with regard to time to adequate analgesia by utilizing a stop watch to measure the time for each unit of study drug in the double blind phase
  • to evaluate the efficacy of ACTIQ treatment compared to placebo treatment for these children by assessing the occurrence of inadequate analgesia as assessed by the use of rescue medication
  • to evaluate the efficacy of ACTIQ treatment compared to placebo treatment for these children by assessing the numbers of patients who withdraw from the study because of inadequate analgesia
  • to evaluate the efficacy of ACTIQ treatment compared to placebo treatment for these children by assessing the duration of analgesic effect by using the FPS-R administered at approximately 30, 45, and 60 minutes after the start of each unit of study drug after an optimal dosage is obtained
  • to determine the distribution of optimal doses of ACTIQ treatment for these children by age group (3 to under
    Sponsor: Cephalon

    Current Primary Outcome: Pain intensity differences as measured by the FPS-R

    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • Time to adequate analgesia
    • Duration of analgesia
    • Percentage of BTP episodes requiring rescue medication, or for which oversedation occurs
    • Amount of rescue medication
    • Distribution of optimal doses


    Original Secondary Outcome:

    • - Time to adequate analgesia
    • - Duration of analgesia
    • - Percentage of BTP episodes requiring rescue-medication, or for which oversedation occurs
    • - Amount of rescue medication
    • - Distribution of optimal doses


    Information By: Teva Pharmaceutical Industries

    Dates:
    Date Received: October 7, 2005
    Date Started: April 2004
    Date Completion: August 2006
    Last Updated: May 8, 2014
    Last Verified: May 2014