Efficacy/Safety Study of ACTIQ® for Opioid-Tolerant Children and Adolescents With Breakthrough Pain (BTP)
Condition: Cancer; Breakthrough Pain
MeSH terms: Breakthrough Pain
Study type: Interventional
Phase: Phase 2

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 description: 
      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 6 years, 6 to under 11 years, and 11 to under 16 years)

        -  to establish a safe and effective titration scheme for ACTIQ in these children during
           the open label phase

        -  to evaluate the safety of ACTIQ treatment for these children through the assessment of
           adverse events, clinical laboratory assessments (serum chemistry and hematology), vital
           sign measurements (including blood pressure, heart rate, and respiration rate),
           hemoglobin-oxygen saturation level (SpO2, measured via pulse oximetry),
           electrocardiograms (ECGs), physical examinations, and level of sedation (measured by the
           University of Michigan Sedation Scale [UMSS])

        -  to characterize the pharmacokinetics profile of ACTIQ (fentanyl citrate) in these
           children

        -  to investigate the exposure and efficacy relationship between plasma concentration of
           fentanyl and clinical measures of analgesia
    

Intervention name(s): ACTIQ®
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Breakthrough Pain; Cancer; Sickle Cell; Severe Burns; Children; Adolescents; Analgesia; Sickle Cell Disease; Non-Cancer