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.
Study Type
OBSERVATIONAL
Enrollment
131
This was an observational study. Therefore, the physician decided about dosage according to individual needs.
Dose of Instanyl
Initially prescribed dose/ most efficient single dose of Instanyl at study end
Time frame: during therapy with Instanyl (planned: 28 days)
Physician: Degree of Maximum Pain Intensity During the Last Days/ Since the Last Examination
Scale: 0=no, 1=mild, 2=moderate, 3=strong, 4=very strong, 5=extreme
Time frame: before and after therapy with Instanyl (first/last visit)
Physician: Assessment of Breakthrough Pain Therapy (Initial Visit: Previous/Last Visit: Instanyl)
Scale: 1=very good, 2=good, 3=satisfactory, 4=poor, 5=very poor, 6=insufficient
Time frame: before and after therapy with Instanyl (first/last visit)
Physician: To What Extent Did Your Expectations in Instanyl Have Met? (Last Visit)
5=completely, 4=for the most part, 3=partially, 2= more or less, 1=rather not, 0=not at all
Time frame: after therapy with Instanyl (planned: 4 weeks)
Physician: To What Extent Changes Have Occurred Induced by the Treatment of Breakthrough Pain With Instanyl With Respect to ... (at Last Visit)
Scale: -3= very much improved, -2= much improved, -1= improved, 0= comparable, 1= worsened, 2= much worsened ,3= very much worsened
Time frame: after therapy with Instanyl (at last visit)
Physician: What is the Current Treatment Needs of Your Patient Regarding ...
Scale: 0=no, 1=low, 2=medium, 3=high
Time frame: before and after therapy with Instanyl (first/last visit)
Physician: Degree of Relief of Breakthrough Pain Achieved by Instanyl at Study End
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0=no reduction, 1=slight, 2=medium, 3=strong, 4=very strong, 5=complete
Time frame: after therapy with Instanyl (planned: 4 weeks)
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
0=no pain, 10= most intense pain imaginable
Time frame: initial visit (before start of therapy with Instanyl)
Patient: How do You Feel Today?
Scale: 1=very bad, 2=bad, 3=mediocre, 4=good, 5=very good
Time frame: before and after therapy with Instanyl (first/last visit)
Patient: To What Extent Your Present Condition is Affected by Your Pain Attacks?
Scale: 0=not at all, 10=completely
Time frame: before and after therapy with Instanyl (first/last visit)
Patient: Modified Pain Disability Index (mPDI) - Sum - Score (Complete Questionnaires Only)
Scale: 0=no impairment, 70=complete impairment
Time frame: before and after therapy with Instanyl (first/last visit)
Patient: Quality-of-Life-Impairment by Pain =QLIP - Sum - Score (Complete Questionnaires Only)
Scale: 0=complete impairment, 43=no impairment
Time frame: before and after therapy with Instanyl (first/last visit)
Patient: Quality-of-Life-Impairment by Pain =QLIP - Sum - Score (Complete Questionnaires Only) Conspicuous ≤20
0= conspicuous ≤20 1= inconspicuous \>20
Time frame: before and after therapy with Instanyl (first/last visit)
Patient: Marburg Questionnaire on Habitual Health (MQHH): Sum - Score (Complete Questionnaires Only)
Scale: 0=worst, 5=best
Time frame: before and after therapy with Instanyl (first/last visit)
Patient: Marburg Questionnaire on Habitual Health (MQHH): Sum - Score (Complete Questionnaires Only) Conspicuous <1.5
conspicuous score \<1.5 inconspicuous score ≥1.5
Time frame: before and after therapy with Instanyl (first/last visit)
Patient: Degree of Relief of Breakthrough Pain Achieved by Instanyl at Study End
0=no reduction, 1=slight, 2=medium, 3=strong, 4=very strong, 5=complete
Time frame: after therapy with Instanyl (planned: 4 weeks)
Patient: Assessment of Breakthrough Pain Therapy (Initial Visit: Previous/Last Visit: Instanyl)
Scale: 1=very good, 2=good, 3=satisfactory, 4=poor, 5=very poor, 6=insufficient
Time frame: before and after therapy with Instanyl (first/last visit)
Patient: To What Extent Did Your Expectations in Instanyl Have Met With Respect to ... (Last Visit)
5=completely, 4=for the most part, 3=partially, 2=more or less, 1=rather not, 0=not at all
Time frame: after therapy with Instanyl (planned: 4 weeks)
Patient: To What Extent Changes Have Occurred Induced by the Treatment of Breakthrough Pain With Instanyl With Respect to ...(at Last Visit)
Scale: -3= very much improved, -2= much improved, -1= improved , 0= comparable, 1= worsened, 2= much worsened, 3= very much worsened
Time frame: after therapy with Instanyl (at last visit)
Caregiver: Degree of Relief of Breakthrough Pain Achieved by Instany at Study End
0=no reduction, 1=slight, 2=medium, 3=strong, 4=very strong, 5=complete
Time frame: after therapy with Instanyl (planned: 4 weeks)
Caregiver: Assessment of Breakthrough Pain Therapy by Instanyl (Last Visit)
Scale: 1=very good, 2=good, 3=satisfactory, 4=poor, 5=very poor, 6=insufficient
Time frame: after therapy with Instanyl (first/last visit)
Caregiver: To What Extent Changes Have Occurred Induced by the Treatment of Breakthrough Pain With Instanyl With Respect to ... (at Last Visit)
Scale: -3= very much improved, -2= much improved, -1= improved , 0= comparable, 1= worsened, 2= much worsened, 3= very much worsened
Time frame: after therapy with Instanyl (at last visit)
Caregiver: To What Extent the Treatment Needs of Your Patient Has Changed by the Use of Instanyl Regarding ...
Scale: -3= very much less, -2= much less, -1= less, 0=comparable, 1= more, 2= much more, 3= very much more
Time frame: after therapy with Instanyl (last visit)