CompletedNCT00994760GENISISUpdated Sep 27, 2012Results posted

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

An observational study in Breakthrough Pain and Cancer, sponsored by Takeda. Completed at 168 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-09-27.

Study 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.

Conditions studied

Breakthrough Pain
Cancer

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Keywords

intranasal fentanyl spray

In context

Breakthrough Pain

34 studies on the registry are indexed under Breakthrough Pain; 4 are open to participants now.

This study's enrollment of 131 is close to the median of 125 across 10 observational studies indexed under Breakthrough Pain.

Browse Breakthrough Pain studies →

Lead sponsor

Takeda is the lead sponsor of 1,026 studies on the registry; 89 are open to participants now.

Of its 178 completed or terminated interventional studies of FDA-regulated products, 154 (87%) have results posted.

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Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Non-probability sample

Study population

Outpatients

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

decision to start treatment with intranasal fentanyl spray
written

Exclusion criteria

Exclusion criteria:

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

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Study design

Observational model: Cohort
Time perspective: Prospective
Enrollment: 131 participants (actual)

Groups and cohorts

GENISIS
Drug: Instanyl (Intranasal Fentanyl)

Interventions

DrugInstanyl (Intranasal Fentanyl)
This was an observational study. Therefore, the physician decided about dosage according to individual needs.

What researchers measure

Primary outcomes

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)

Secondary outcomes

Physician: 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: 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)

Results

Posted Sep 27, 2012

Participant flow

Participant flow — Overall Study
Milestone	GENISIS
Started	131
Completed	107
Not completed	24

Outcome measures

PrimaryDose of Instanyl

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

Time frame:: during therapy with Instanyl (planned: 28 days)
Reported as:: Number · participants

Dose of Instanyl
participants	Study Start	Study End
50 µg	75	30
100 µg	50	69
200 µg	5	15
400 µg	0	1
Missing	1	1

PrimaryPhysician: 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)
Reported as:: Mean · units on a scale

Physician: Degree of Maximum Pain Intensity During the Last Days/ Since the Last Examination
units on a scale	Initial Visit	Last Visit
Persistent pain (IV: N= 126, LV: N= 116)	2.3 ± 1.1	1.6 ± 0.9
Breakthrough pain (IV: N= 126, LV: N= 115)	3.5 ± 0.9	1.8 ± 1.2

SecondaryPhysician: 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)
Reported as:: Mean · units on a scale

Physician: Degree of Relief of Breakthrough Pain Achieved by Instanyl at Study End
units on a scale	Last Visit
Physician: Degree of Relief of Breakthrough Pain Achieved by Instanyl at Study End	3.4 ± 1.0

PrimaryPhysician: 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)
Reported as:: Mean · units on a scale

Physician: Assessment of Breakthrough Pain Therapy (Initial Visit: Previous/Last Visit: Instanyl)
units on a scale	First Visit (FV): Patients With Previous BTP- Medication Only	Last Visit (LV)
speed of action (FV: N= 45, LV: N= 114)	4.0 ± 1.3	1.7 ± 0.8
strength of action (FV: N= 45, LV: N= 115)	4.0 ± 1.3	1.8 ± 0.9
tolerability (FV: N= 44, LV: N= 113)	3.0 ± 1.4	1.7 ± 0.6
safety (FV: N= 45, LV: N= 114)	2.9 ± 1.2	1.7 ± 0.6
handling (FV: N= 45, LV: N= 115)	3.4 ± 1.4	2.1 ± 1.2
patient satisfaction (FV: N= 45, LV: N= 116)	4.2 ± 1.3	1.9 ± 1.1

PrimaryPhysician: 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)
Reported as:: Mean · units on a scale

Physician: To What Extent Did Your Expectations in Instanyl Have Met? (Last Visit)
units on a scale	Physician Last Visit (LV)
Physician: To What Extent Did Your Expectations in Instanyl Have Met? (Last Visit)	4.4 ± 0.7

PrimaryPhysician: 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)
Reported as:: Mean · units on a scale

Physician: To What Extent Changes Have Occurred Induced by the Treatment of Breakthrough Pain With Instanyl With Respect to ... (at Last Visit)
units on a scale	GENISIS
Nursing and support efforts (N= 113)	-1.2 ± 1.0
Autonomy of the patient (N= 113)	-1.5 ± 0.9
Pain-related impairment in everyday life (N= 113)	-1.6 ± 0.9
Quality of patient's life (N= 112)	-1.5 ± 0.9
Extent of use of other medical services (N= 112)	-1.1 ± 1.0

PrimaryPhysician: 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)
Reported as:: Mean · units on a scale

Physician: What is the Current Treatment Needs of Your Patient Regarding ...
units on a scale	Initial Visit (IV)	Last Visit (LV)
persistent pain (IV: N=131, LV: N=112)	2.0 ± 0.8	1.3 ± 0.8
breakthrough pain (IV: N=130, LV: N=111)	2.5 ± 0.6	1.2 ± 0.8
nausea (IV: N=130, LV: N=112)	1.5 ± 0.8	0.9 ± 0.8
vomiting (IV: N=130, LV: N=112)	1.2 ± 0.9	0.7 ± 0.7
dyspnoea (IV: N=130, LV: N=111)	1.0 ± 0.9	0.7 ± 0.8
constipation (IV: N=129, LV: N=112)	1.2 ± 0.9	0.8 ± 0.8
weakness (IV: N=129, LV: N=112)	2.0 ± 0.8	1.4 ± 1.0
poor appetite (IV: N=131, LV: N=112)	1.8 ± 0.9	1.4 ± 1.0
tiredness (IV: N=130, LV: N=112)	1.8 ± 0.8	1.4 ± 0.9
efforts due to wounds/decubitus (N=130, N=112)	1.0 ± 1.0	0.8 ± 0.9
need for assistance (IV: N=130, LV: N=111)	1.8 ± 0.9	1.3 ± 0.9
depressiveness (IV: N=129, LV: N=111)	1.6 ± 0.8	1.1 ± 0.8
anxiety (IV: N=130, LV: N=112)	1.6 ± 0.8	1.1 ± 0.7
tension (IV: N=130, LV: N=112)	1.6 ± 0.9	1.2 ± 0.8
disorientation, confusion (IV: N=130, LV: N=111)	0.6 ± 0.8	0.5 ± 0.7
Problems with organization of care (N=129, N=112)	1.1 ± 1.0	0.8 ± 0.8
Overburdening family/environment N=129, N=112	1.4 ± 1.0	1.0 ± 0.8

SecondaryPatient: How Many Episodes of Pain You Experience on Average?

Time frame:: initial visit (before start of therapy with Instanyl)
Reported as:: Mean · episodes per day

Patient: How Many Episodes of Pain You Experience on Average?
episodes per day	First Visit
Patient: How Many Episodes of Pain You Experience on Average?	3.0 ± 2.2

SecondaryPatient: Description of Pain at Initial Visit

0=no pain, 10= most intense pain imaginable

Time frame:: initial visit (before start of therapy with Instanyl)
Reported as:: Mean · units on a scale

Patient: Description of Pain at Initial Visit
units on a scale	Patients at First Visit
Persistent pain in the last 24 hrs on average N=94	5.6 ± 2.3
Pain during the last pain attacks maximally N=93	8.3 ± 1.4
Pain intensity bearable N= 94	4.0 ± 1.5

SecondaryPatient: 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)
Reported as:: Mean · units on a scale

Patient: How do You Feel Today?
units on a scale	Initial Visit	Last Visit
Patient: How do You Feel Today?	2.2 ± 0.7	3.3 ± 0.8

SecondaryPatient: 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)
Reported as:: Mean · units on a scale

Patient: To What Extent Your Present Condition is Affected by Your Pain Attacks?
units on a scale	Initial Visit	Last Visit
Patient: To What Extent Your Present Condition is Affected by Your Pain Attacks?	7.6 ± 1.7	3.8 ± 2.3

SecondaryPatient: 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)
Reported as:: Mean · units on a scale

Patient: Modified Pain Disability Index (mPDI) - Sum - Score (Complete Questionnaires Only)
units on a scale	Initial Visit	Last Visit
Patient: Modified Pain Disability Index (mPDI) - Sum - Score (Complete Questionnaires Only)	51.9 ± 11.4	29.1 ± 16.3

SecondaryPatient: 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)
Reported as:: Mean · units on a scale

Patient: Quality-of-Life-Impairment by Pain =QLIP - Sum - Score (Complete Questionnaires Only)
units on a scale	Initial Visit	Last Visit
Patient: Quality-of-Life-Impairment by Pain =QLIP - Sum - Score (Complete Questionnaires Only)	12.3 ± 6.6	24.7 ± 7.3

SecondaryPatient: 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)
Reported as:: Number · participants

Patient: Quality-of-Life-Impairment by Pain =QLIP - Sum - Score (Complete Questionnaires Only) Conspicuous ≤20
participants	Initial Visit	Last Visit
QLIP - score (classified):QLIP conspicuous (≤20)	80	21
QLIP - score (classified):QLIP inconspicuous (>20)	13	61
Missing	2	1

SecondaryPatient: 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)
Reported as:: Mean · units on a scale

Patient: Marburg Questionnaire on Habitual Health (MQHH): Sum - Score (Complete Questionnaires Only)
units on a scale	Initial Visit	Last Visit
Patient: Marburg Questionnaire on Habitual Health (MQHH): Sum - Score (Complete Questionnaires Only)	1.2 ± 1.0	2.2 ± 1.2

SecondaryPatient: 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)
Reported as:: Number · participants

Patient: Marburg Questionnaire on Habitual Health (MQHH): Sum - Score (Complete Questionnaires Only) Conspicuous <1.5
participants	Initial Visit	Last Visit
MQHH - score (classified):conspicuous:score <1.5	62	24
MQHH - score (classified):inconspicuous:score ≥1.5	31	57
Missing	2	2

SecondaryPatient: 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)
Reported as:: Mean · units on a scale

Patient: Degree of Relief of Breakthrough Pain Achieved by Instanyl at Study End
units on a scale	Patients at Final Visit
Patient: Degree of Relief of Breakthrough Pain Achieved by Instanyl at Study End	3.4 ± 1.0

SecondaryPatient: 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)
Reported as:: Mean · units on a scale

Patient: Assessment of Breakthrough Pain Therapy (Initial Visit: Previous/Last Visit: Instanyl)
units on a scale	First Visit (FV)(Patients With Previous BTP-medication Only)	Last Visit (LV)
speed of action (FV: N=33, LV: N=82)	4.1 ± 1.1	2.0 ± 1.0
strength of action (FV: N=33, LV: N=82)	3.9 ± 1.2	2.0 ± 1.1
tolerability (FV: N=33, LV: N=82)	3.2 ± 1.1	2.0 ± 1.1
handling (FV: N=33, LV: N=80)	3.4 ± 1.3	2.0 ± 1.0
total satisfaction (FV: N=NA, LV: N=82)	NA ± NA	2.0 ± 1.1

SecondaryPatient: 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)
Reported as:: Mean · units on a scale

Patient: To What Extent Did Your Expectations in Instanyl Have Met With Respect to ... (Last Visit)
units on a scale	Patients at Final Visit
speed of action (N=79)	4.2 ± 0.8
strength of action (N=80)	4.2 ± 0.9
tolerability (N=78)	4.3 ± 0.7
handling (N=79)	4.2 ± 0.9
total satisfaction (N=80)	4.2 ± 0.9

SecondaryPatient: 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)
Reported as:: Mean · units on a scale

Patient: To What Extent Changes Have Occurred Induced by the Treatment of Breakthrough Pain With Instanyl With Respect to ...(at Last Visit)
units on a scale	Patients at Final Visit
Nursing and support efforts (N= 81)	-1.0 ± 0.9
Autonomy of the patient (N= 81)	-1.4 ± 0.8
Pain-related impairment in everyday life (N= 81)	-1.3 ± 0.8
Quality of patient's life (N= 81)	-1.4 ± 0.8

SecondaryCaregiver: 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)
Reported as:: Mean · units on a scale

Caregiver: Degree of Relief of Breakthrough Pain Achieved by Instany at Study End
units on a scale	Caregiver at Final Visit
Caregiver: Degree of Relief of Breakthrough Pain Achieved by Instany at Study End	3.3 ± 1.0

SecondaryCaregiver: 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)
Reported as:: Mean · units on a scale

Caregiver: Assessment of Breakthrough Pain Therapy by Instanyl (Last Visit)
units on a scale	Caregiver at Final Visit
speed of action (N=69)	2.2 ± 0.8
strength of action (N=69)	2.1 ± 0.9
tolerability (N=69)	1.9 ± 0.8
safety (N=68)	2.0 ± 0.8
handling (N=69)	2.2 ± 1.1
patient satisfaction (N=68)	2.1 ± 1.0

SecondaryCaregiver: 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)
Reported as:: Mean · units on a scale

Caregiver: To What Extent Changes Have Occurred Induced by the Treatment of Breakthrough Pain With Instanyl With Respect to ... (at Last Visit)
units on a scale	Caregiver at Final Visit
Nursing and support efforts (N= 69)	-0.8 ± 0.8
Autonomy of the patient (N= 69)	-1.2 ± 0.8
Pain-related impairment in everyday life (N= 69)	-1.3 ± 0.8
Quality of patient's life (N= 68)	-1.3 ± 0.7
Extent of use of other medical services (N= 69)	-0.9 ± 0.8

SecondaryCaregiver: 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)
Reported as:: Mean · units on a scale

Caregiver: To What Extent the Treatment Needs of Your Patient Has Changed by the Use of Instanyl Regarding ...
units on a scale	Caregiver at Final Visit
persistent pain (N=68)	-1.2 ± 0.9
breakthrough pain (N=68)	-1.8 ± 0.8
nausea (N=68)	-1.1 ± 1.0
vomiting (N=65)	-0.9 ± 1.0
dyspnoea (N=66)	-1.1 ± 1.1
constipation (N=68)	-0.8 ± 1.1
weakness (N=68)	-0.7 ± 0.9
poor appetite (N=68)	-0.7 ± 1.0
tiredness (N=67)	-0.8 ± 1.0
efforts due to wounds/decubitus (N=68)	-0.8 ± 1.0
need for assistance in daily activities (N=68)	-1.1 ± 1.0
depressiveness (N=67)	-1.0 ± 1.1
anxiety (N=67)	-1.2 ± 1.1
tension (N=67)	-1.1 ± 1.0
disorientation, confusion (N=67)	-0.9 ± 1.1
Problems with the organization of care (N=68)	-1.0 ± 1.1
Overburdening family/environment (N=68)	-1.2 ± 1.1

Adverse events

Collected over First until last visit (planned 4 weeks). Non-serious events are listed at a 2% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
All Patients Treated	—	19/131 (14.5%)	0/131 (0%)

Most frequent serious events

Most frequent serious events
Event	All Patients Treated
DeathGeneral disorders	18/131
OsteosynthesisSurgical and medical procedures	1/131

Baseline characteristics

Age Continuous
Age Continuous(years)	GENISIS
Mean	62.1 ± 12.1

Sex/Gender, Customized
Sex/Gender, Customized(participants)	GENISIS
Female	60
Male	67
Missing	4

Body Mass Index (BMI)
Body Mass Index (BMI)(kgˆm2)	GENISIS
Mean	23.2 ± 4.4

Tumor diagnosis (malignant neop-lasms ICD10)
Tumor diagnosis (malignant neop-lasms ICD10)(percentage of participants)	GENISIS
Pain not caused by tumor	2.3
C00-C14 lip, oral cavity and pharynx	6.1
C15-C26 digestive organs	26.0
C30-C39 respiratory and intrathoracic organs	16.0
C40-C41 bone and articular cartilage	0.8
C43-C44 Melanoma and other skin	0.8
C50-C50 Mamma	20.6
C51-C58 female genital organs	3.1
C60-C63 male genital organs	13.0
C64-C68 urinary tract	5.3
C73-C75 thyroid and other endocrine glands	0.8
C76-C80 ill-defined, secondary + unspecified sites	0.8
C81-C96 lymphoid, hematopoietic and related tissue	0.8
Missing	3.8

Karnofsky-index
Karnofsky-index(scores)	GENISIS
Mean	58.6 ± 21.6

American Society of Anesthesiologists (ASA)-physical state (2-5)
American Society of Anesthesiologists (ASA)-physical state (2-5)(participants)	GENISIS
ASA 2	22
ASA 3	40
ASA 4	59
ASA 5	5
Missing	5

ECOG (Eastern Cooperative Oncology Group) performance status (0-4)
ECOG (Eastern Cooperative Oncology Group) performance status (0-4)(participants)	GENISIS
ECOG 0	2
ECOG 1	33
ECOG 2	40
ECOG 3	36
ECOG 4	14
Missing	6

Reason for the use of Instanyl
Reason for the use of Instanyl(participants)	GENISIS
No previous BTP medication	86
Previous BTP medic./Insufficient efficacy	32
Previous BTP medic./Insufficient speed of action	32
Previous BTP medic./Insufficient handling	12
Previous BTP medic./Insufficient tolerability	6
Previous BTP medic./Other reasons	7

Study locations

168 sites

Nycomed Deutschland GmbH
Aachen, 52074, Germany
Nycomed Deutschland GmbH
Adendorf, 21365, Germany
Nycomed Deutschland GmbH
Aichach, 86551, Germany
Nycomed Deutschland GmbH
Albstadt-Ebingen, 72458, Germany
Nycomed Deutschland GmbH
Albstadt, 72458, Germany
Nycomed Deutschland GmbH
Altenkirchen, 57610, Germany
Nycomed Deutschland GmbH
Aschaffenburg, 63743, Germany
Nycomed Deutschland GmbH
Aschersleben, 06449, Germany
Nycomed Deutschland GmbH
Augsburg, 86150, Germany
Nycomed Deutschland GmbH
Augsburg, 86163, Germany
Nycomed Deutschland GmbH
Backnang, 71522, Germany
Nycomed Deutschland GmbH
Bad Bevensen, 29545, Germany
Nycomed Deutschland GmbH
Bad Dürkheim, 67098, Germany
Nycomed Deutschland GmbH
Bad Liebenstein, 36448, Germany
Nycomed Deutschland GmbH
Bad Pyrmont, 31812, Germany
Nycomed Deutschland GmbH
Bad Schwalbach, 65307, Germany
Nycomed Deutschland GmbH
Badel, 39624, Germany
Nycomed Deutschland GmbH
Bademühlen, 27404, Germany
Nycomed Deutschland GmbH
Bautzen, 02625, Germany
Nycomed Deutschland GmbH
Berlin, 10317, Germany
Nycomed Deutschland GmbH
Berlin, 10409, Germany
Nycomed Deutschland GmbH
Berlin, 10437, Germany
Nycomed Deutschland GmbH
Berlin, 10713, Germany
Nycomed Deutschland GmbH
Berlin, 10715, Germany
Nycomed Deutschland GmbH
Berlin, 10999, Germany
Nycomed Deutschland GmbH
Berlin, 12107, Germany
Nycomed Deutschland GmbH
Berlin, 12627, Germany
Nycomed Deutschland GmbH
Berlin, 13055, Germany
Nycomed Deutschland GmbH
Bochum, 44801, Germany
Nycomed Deutschland GmbH
Bonn, 53177, Germany
Nycomed Deutschland GmbH
Brandenburg/Havel, 14776, Germany
Nycomed Deutschland GmbH
Braunschweig, 38100, Germany
Nycomed Deutschland GmbH
Bremen, 28329, Germany
Nycomed Deutschland GmbH
Brühl, 50321, Germany
Nycomed Deutschland GmbH
Burg/Fehmarn, 23769, Germany
Nycomed Deutschland GmbH
Burg, 39288, Germany
Nycomed Deutschland GmbH
Burscheid, 51399, Germany
Nycomed Deutschland GmbH
Butzbach, 35510, Germany
Nycomed Deutschland GmbH
Böblingen, 71034, Germany
Nycomed Deutschland GmbH
Coburg, 96450, Germany
Nycomed Deutschland GmbH
Cochem, 56812, Germany
Nycomed Deutschland GmbH
Cottbus, 03050, Germany
Nycomed Deutschland GmbH
Cuxhaven, 27472, Germany
Nycomed Deutschland GmbH
Cuxhaven, 27474, Germany
Nycomed Deutschland GmbH
Dessau-Roßlau, 06846, Germany
Nycomed Deutschland GmbH
Dresden, 01127, Germany
Nycomed Deutschland GmbH
Dresden, 01307, Germany
Nycomed Deutschland GmbH
Dresden, 01309, Germany
Nycomed Deutschland GmbH
Duisburg, 47137, Germany
Nycomed Deutschland GmbH
Düsseldorf, 40589, Germany
Nycomed Deutschland GmbH
Essen, 45326, Germany
Nycomed Deutschland GmbH
Etzenricht, 92694, Germany
Nycomed Deutschland GmbH
Fehmarn, 23769, Germany
Nycomed Deutschland GmbH
Frankfurt, 60311, Germany
Nycomed Deutschland GmbH
Frankfurt, 60313, Germany
Nycomed Deutschland GmbH
Frankfurt, 60590, Germany
Nycomed Deutschland GmbH
Freiburg, 79108, Germany
Nycomed Deutschland GmbH
Friedberg, 86316, Germany
Nycomed Deutschland GmbH
Geesthacht, 21502, Germany
Nycomed Deutschland GmbH
Großheirath-Rossach, 96269, Germany
Nycomed Deutschland GmbH
Göppingen, 73033, Germany
Nycomed Deutschland GmbH
Görlitz, 02826, Germany
Nycomed Deutschland GmbH
Gütersloh, 33330, Germany
Nycomed Deutschland GmbH
Hachenburg, 57627, Germany
Nycomed Deutschland GmbH
Hainburg, 63512, Germany
Nycomed Deutschland GmbH
Halle, 06110, Germany
Nycomed Deutschland GmbH
Halle, 06120, Germany
Nycomed Deutschland GmbH
Hamburg, 20095, Germany
Nycomed Deutschland GmbH
Hamburg, 22765, Germany
Nycomed Deutschland GmbH
Hameln, 31785, Germany
Nycomed Deutschland GmbH
Hannover, 30161, Germany
Nycomed Deutschland GmbH
Hannover, 30167, Germany
Nycomed Deutschland GmbH
Hannover, 30625, Germany
Nycomed Deutschland GmbH
Heidelberg, 69115, Germany
Nycomed Deutschland GmbH
Hellenthal, 53940, Germany
Nycomed Deutschland GmbH
Herne, 44625, Germany
Nycomed Deutschland GmbH
Herzlake, 49770, Germany
Nycomed Deutschland GmbH
Hohberg-Hofweiler, 77749, Germany
Nycomed Deutschland GmbH
Hohberg, 77749, Germany
Nycomed Deutschland GmbH
Holzminden, 37603, Germany
Nycomed Deutschland GmbH
Husum, 25813, Germany
Nycomed Deutschland GmbH
Iserlohn, 58638, Germany
Nycomed Deutschland GmbH
Itzehoe, 25524, Germany
Nycomed Deutschland GmbH
Jerichow, 39319, Germany
Nycomed Deutschland GmbH
Kaiserslautern, 67655, Germany
Nycomed Deutschland GmbH
Karlsbad, 76307, Germany
Nycomed Deutschland GmbH
Katzhütte, 98746, Germany
Nycomed Deutschland GmbH
Kevelaar, 47625, Germany
Nycomed Deutschland GmbH
Kiel, 24105, Germany
Nycomed Deutschland GmbH
Kiel, 24106, Germany
Nycomed Deutschland GmbH
Kiel, 24149, Germany
Nycomed Deutschland GmbH
Kirchberg, 08107, Germany
Nycomed Deutschland GmbH
Koblenz, 56068, Germany
Nycomed Deutschland GmbH
Koblenz, 56072, Germany
Nycomed Deutschland GmbH
Krefeld, 47798, Germany
Nycomed Deutschland GmbH
Krefeld, 47799, Germany
Nycomed Deutschland GmbH
Krefeld, 47803, Germany
Nycomed Deutschland GmbH
Köln, 50733, Germany
Nycomed Deutschland GmbH
Köln, 50935, Germany
Nycomed Deutschland GmbH
Köln, 50937, Germany

Showing the first 100 of 168 sites. Choose a country and city above to see the rest.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 27, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00994760
Lead sponsor: Takeda
Responsible party: Sponsor
First posted: Oct 14, 2009
Start date: Sep 2009
Primary completion: Sep 2010
Completion: Nov 2010
Results posted: Sep 27, 2012
Last update: Sep 27, 2012

Study contacts

Dr. Thomas D. Bethke, PhD; MD

study director · Nycomed Deutschland GmbH, 78467 Konstanz, Germany

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2012. You cannot join it, but the record below documents what was studied.

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