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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT00994760
First received: October 5, 2009
Last updated: August 27, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention
Breakthrough Pain
Cancer
Drug: Instanyl (Intranasal Fentanyl)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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.

Resource links provided by NLM:


Further study details as provided by Takeda:

Primary Outcome Measures:
  • Dose of Instanyl [ Time Frame: during therapy with Instanyl (planned: 28 days) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    Scale: 0=no, 1=low, 2=medium, 3=high


Secondary Outcome Measures:
  • Physician: Degree of Relief of Breakthrough Pain Achieved by Instanyl at Study End [ Time Frame: after therapy with Instanyl (planned: 4 weeks) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
  • Patient: Description of Pain at Initial Visit [ Time Frame: initial visit (before start of therapy with Instanyl) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]

    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    Scale: -3= very much less, -2= much less, -1= less, 0=comparable, 1= more, 2= much more, 3= very much more


Enrollment: 131
Study Start Date: September 2009
Study Completion Date: November 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
GENISIS Drug: Instanyl (Intranasal Fentanyl)
This was an observational study. Therefore, the physician decided about dosage according to individual needs.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Outpatients

Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00994760

  Show 168 Study Locations
Sponsors and Collaborators
Takeda
Investigators
Study Director: Dr. Thomas D. Bethke, PhD; MD Nycomed Deutschland GmbH, 78467 Konstanz, Germany
  More Information

No publications provided

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT00994760     History of Changes
Other Study ID Numbers: FT-1301-401-DE
Study First Received: October 5, 2009
Results First Received: March 13, 2012
Last Updated: August 27, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Takeda:
intranasal fentanyl spray

Additional relevant MeSH terms:
Breakthrough Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Fentanyl
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics

ClinicalTrials.gov processed this record on September 16, 2014