Clinical Trial: Efficacy and Tolerability of Intranasal Fentanyl Spray for the Treatment of Breakthrough Pain in Cancer Patients Older Than 18 Years

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: A Prospective Non-interventional/Observational Patient Cohort Study on the Efficacy of Intranasal Fentanyl Spray for the Treatment of Breakthrough Pain in Cancer Patients.

Brief Summary: The aim of the study was to evaluate the safety and efficacy of intranasal fentanyl spray in cancer patients over four weeks, especially during cancer-related breakthrough pain (BTP) attacks. The fentanyl spray was applied into the nose by a metered-spray device. The study was to provide further data on pharmacoeconomic efficiency of intranasal fentanyl spray.

Detailed Summary:
Sponsor: Takeda

Current Primary Outcome:

  • Dose of Instanyl [ Time Frame: during therapy with Instanyl (planned: 28 days) ]
    Initially prescribed dose/ most efficient single dose of Instanyl at study end
  • Physician: Degree of Maximum Pain Intensity During the Last Days/ Since the Last Examination [ Time Frame: before and after therapy with Instanyl (first/last visit) ]
    Scale: 0=no, 1=mild, 2=moderate, 3=strong, 4=very strong, 5=extreme
  • Physician: Assessment of Breakthrough Pain Therapy (Initial Visit: Previous/Last Visit: Instanyl) [ Time Frame: before and after therapy with Instanyl (first/last visit) ]
    Scale: 1=very good, 2=good, 3=satisfactory, 4=poor, 5=very poor, 6=insufficient
  • Physician: To What Extent Did Your Expectations in Instanyl Have Met? (Last Visit) [ Time Frame: after therapy with Instanyl (planned: 4 weeks) ]
    5=completely, 4=for the most part, 3=partially, 2= more or less, 1=rather not, 0=not at all
  • Physician: To What Extent Changes Have Occurred Induced by the Treatment of Breakthrough Pain With Instanyl With Respect to ... (at Last Visit) [ Time Frame: after therapy with Instanyl (at last visit) ]
    Scale: -3= very much improved, -2= much improved, -1= improved, 0= comparable, 1= worsened, 2= much worsened ,3= very much worsened
  • Physician: What is the Current Treatment Needs of Your Patient Regarding ... [ Time Frame: before and after therapy with Instanyl (first/last visit) ]
  • pharmacoeconomic efficiency of INFS in the treatment of cancer-related breakthrough pain (BTP) attacks by reproducible treatment success [ Time Frame: during four weeks of treatment period ]
  • INFS-related reduction of health-/home-/family-care resource utilization [ Time Frame: during four weeks of treatment period ]


Current Secondary Outcome:

  • Physician: Degree of Relief of Breakthrough Pain Achieved by Instanyl at Study End [ Time Frame: after therapy with Instanyl (planned: 4 weeks) ]
    0=no reduction, 1=slight, 2=medium, 3=strong, 4=very strong, 5=complete
  • Patient: How Many Episodes of Pain You Experience on Average? [ Time Frame: initial visit (before start of therapy with Instanyl) ]
  • Patient: Description of Pain at Initial Visit [ Time Frame: initial visit (before start of therapy with Instanyl) ]
    0=no pain, 10= most intense pain imaginable
  • Patient: How do You Feel Today? [ Time Frame: before and after therapy with Instanyl (first/last visit) ]
    Scale: 1=very bad, 2=bad, 3=mediocre, 4=good, 5=very good
  • Patient: To What Extent Your Present Condition is Affected by Your Pain Attacks? [ Time Frame: before and after therapy with Instanyl (first/last visit) ]
    Scale: 0=not at all, 10=completely
  • Patient: Modified Pain Disability Index (mPDI) - Sum - Score (Complete Questionnaires Only) [ Time Frame: before and after therapy with Instanyl (first/last visit) ]
    Scale: 0=no impairment, 70=complete impairment
  • Patient: Quality-of-Life-Impairment by Pain =QLIP - Sum - Score (Complete Questionnaires Only) [ Time Frame: before and after therapy with Instanyl (first/last visit) ]
    Scale: 0=complete impairment, 43=no impairment
  • Patient: Quality-of-Life-Impairment by Pain =QLIP - Sum - Score (Complete Questionnaires Only) Conspicuous ≤20 [ Time Frame: before and after therapy with Instanyl (first/last visit) ]

    0= conspicuous ≤20

    1= inconspicuous >20

  • Patient: Marburg Questionnaire on Habitual Health (MQHH): Sum - Score (Complete Questionnaires Only) [ Time Frame: before and after therapy with Instanyl (first/last visit) ]
    Scale: 0=worst, 5=best
  • Patient: Marburg Questionnaire on Habitual Health (MQHH): Sum - Score (Complete Questionnaires Only) Conspicuous <1.5 [ Time Frame: before and after therapy with Instanyl (first/last visit) ]
    conspicuous score <1.5 inconspicuous score ≥1.5
  • Patient: Degree of Relief of Breakthrough Pain Achieved by Instanyl at Study End [ Time Frame: after therapy with Instanyl (planned: 4 weeks) ]
    0=no reduction, 1=slight, 2=medium, 3=strong, 4=very strong, 5=complete
  • Patient: Assessment of Breakthrough Pain Therapy (Initial Visit: Previous/Last Visit: Instanyl) [ Time Frame: before and after therapy with Instanyl (first/last visit) ]
    Scale: 1=very good, 2=good, 3=satisfactory, 4=poor, 5=very poor, 6=insufficient
  • Patient: To What Extent Did Your Expectations in Instanyl Have Met With Respect to ... (Last Visit) [ Time Frame: after therapy with Instanyl (planned: 4 weeks) ]
    5=completely, 4=for the most part, 3=partially, 2=more or less, 1=rather not, 0=not at all
  • Patient: To What Extent Changes Have Occurred Induced by the Treatment of Breakthrough Pain With Instanyl With Respect to ...(at Last Visit) [ Time Frame: after therapy with Instanyl (at last visit) ]
    Scale: -3= very much improved, -2= much improved, -1= improved , 0= comparable, 1= worsened, 2= much worsened, 3= very much worsened
  • Caregiver: Degree of Relief of Breakthrough Pain Achieved by Instany at Study End [ Time Frame: after therapy with Instanyl (planned: 4 weeks) ]
    0=no reduction, 1=slight, 2=medium, 3=strong, 4=very strong, 5=complete
  • Caregiver: Assessment of Breakthrough Pain Therapy by Instanyl (Last Visit) [ Time Frame: after therapy with Instanyl (first/last visit) ]
    Scale: 1=very good, 2=good, 3=satisfactory, 4=poor, 5=very poor, 6=insufficient
  • Caregiver: To What Extent Changes Have Occurred Induced by the Treatment of Breakthrough Pain With Instanyl With Respect to ... (at Last Visit) [ Time Frame: after therapy with Instanyl (at last visit) ]
    Scale: -3= very much improved, -2= much improved, -1= improved , 0= comparable, 1= worsened, 2= much worsened, 3= very much worsened
  • Caregiver: To What Extent the Treatment Needs of Your Patient Has Changed by the Use of Instanyl Regarding ... [ Time Frame: after therapy with Instanyl (last visit) ]
    Scale: -3= very much less, -2= much less, -1= less, 0=comparable,

    Original Secondary Outcome:

    • analgetic efficacy of INFS for BTP by success of titration, distribution of dose strength, time-specific improvement rates, and in comparison to alternative treatment regimes [ Time Frame: during four weeks of treatment period ]
    • Safety and tolerability of instanyl through reporting of adverse drug reactions [ Time Frame: during four weeks of treatment period ]
    • quality of life [ Time Frame: during four weeks of treatment period ]


    Information By: Takeda

    Dates:
    Date Received: October 5, 2009
    Date Started: September 2009
    Date Completion:
    Last Updated: August 27, 2012
    Last Verified: August 2012