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Completed

NCT Number: NCT00994760

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

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.

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Key information

Conditions

Breakthrough Pain Cancer Neoplasms Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Nycomed Deutschland GmbH, Aachen, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • decision to start treatment with intranasal fentanyl spray
  • written informed consent

Exclusion criteria

  • criteria as defined in the Summary of Product Characteristics (Fachinformation Chapter 4.3)

Treatment and study plan

Instanyl (Intranasal Fentanyl)

Drug

This was an observational study. Therefore, the physician decided about dosage according to individual needs.

Primary outcomes

  1. Dose of Instanyl

    Time frame: during therapy with Instanyl (planned: 28 days)

    Initially prescribed dose/ most efficient single dose of Instanyl at study end

  2. 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

  3. 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

  4. 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

  5. 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

  6. Physician: What is the Current Treatment Needs of Your Patient Regarding ...

    Time frame: before and after therapy with Instanyl (first/last visit)

    Scale: 0=no, 1=low, 2=medium, 3=high

Secondary outcomes

  1. 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

  2. Patient: How Many Episodes of Pain You Experience on Average?

    Time frame: initial visit (before start of therapy with Instanyl)

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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, 1= more, 2= much more, 3= very much more

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Official study 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.

Acronym: GENISIS

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Oct 14, 2009
Registry last updated
Sep 27, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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