Trial Outcomes & Findings for Efficacy and Tolerability of Intranasal Fentanyl Spray for the Treatment of Breakthrough Pain in Cancer Patients Older Than 18 Years (NCT NCT00994760)
NCT ID: NCT00994760
Last Updated: 2012-09-27
Results Overview
Initially prescribed dose/ most efficient single dose of Instanyl at study end
COMPLETED
131 participants
during therapy with Instanyl (planned: 28 days)
2012-09-27
Participant Flow
Participant milestones
| Measure |
GENISIS
Intranasal Fentanyl Spray
|
|---|---|
|
Overall Study
STARTED
|
131
|
|
Overall Study
COMPLETED
|
107
|
|
Overall Study
NOT COMPLETED
|
24
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy and Tolerability of Intranasal Fentanyl Spray for the Treatment of Breakthrough Pain in Cancer Patients Older Than 18 Years
Baseline characteristics by cohort
| Measure |
GENISIS
n=131 Participants
Intranasal Fentanyl Spray
|
|---|---|
|
Age Continuous
|
62.1 years
STANDARD_DEVIATION 12.1 • n=5 Participants
|
|
Sex/Gender, Customized
Female
|
60 participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
67 participants
n=5 Participants
|
|
Sex/Gender, Customized
Missing
|
4 participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
23.2 kgˆm2
STANDARD_DEVIATION 4.4 • n=5 Participants
|
|
Tumor diagnosis (malignant neop-lasms ICD10)
Pain not caused by tumor
|
2.3 percentage of participants
n=5 Participants
|
|
Tumor diagnosis (malignant neop-lasms ICD10)
C00-C14 lip, oral cavity and pharynx
|
6.1 percentage of participants
n=5 Participants
|
|
Tumor diagnosis (malignant neop-lasms ICD10)
C15-C26 digestive organs
|
26.0 percentage of participants
n=5 Participants
|
|
Tumor diagnosis (malignant neop-lasms ICD10)
C30-C39 respiratory and intrathoracic organs
|
16.0 percentage of participants
n=5 Participants
|
|
Tumor diagnosis (malignant neop-lasms ICD10)
C40-C41 bone and articular cartilage
|
0.8 percentage of participants
n=5 Participants
|
|
Tumor diagnosis (malignant neop-lasms ICD10)
C43-C44 Melanoma and other skin
|
0.8 percentage of participants
n=5 Participants
|
|
Tumor diagnosis (malignant neop-lasms ICD10)
C50-C50 Mamma
|
20.6 percentage of participants
n=5 Participants
|
|
Tumor diagnosis (malignant neop-lasms ICD10)
C51-C58 female genital organs
|
3.1 percentage of participants
n=5 Participants
|
|
Tumor diagnosis (malignant neop-lasms ICD10)
C60-C63 male genital organs
|
13.0 percentage of participants
n=5 Participants
|
|
Tumor diagnosis (malignant neop-lasms ICD10)
C64-C68 urinary tract
|
5.3 percentage of participants
n=5 Participants
|
|
Tumor diagnosis (malignant neop-lasms ICD10)
C73-C75 thyroid and other endocrine glands
|
0.8 percentage of participants
n=5 Participants
|
|
Tumor diagnosis (malignant neop-lasms ICD10)
C76-C80 ill-defined, secondary + unspecified sites
|
0.8 percentage of participants
n=5 Participants
|
|
Tumor diagnosis (malignant neop-lasms ICD10)
C81-C96 lymphoid, hematopoietic and related tissue
|
0.8 percentage of participants
n=5 Participants
|
|
Tumor diagnosis (malignant neop-lasms ICD10)
Missing
|
3.8 percentage of participants
n=5 Participants
|
|
Karnofsky-index
|
58.6 scores
STANDARD_DEVIATION 21.6 • n=5 Participants
|
|
American Society of Anesthesiologists (ASA)-physical state (2-5)
ASA 2
|
22 participants
n=5 Participants
|
|
American Society of Anesthesiologists (ASA)-physical state (2-5)
ASA 3
|
40 participants
n=5 Participants
|
|
American Society of Anesthesiologists (ASA)-physical state (2-5)
ASA 4
|
59 participants
n=5 Participants
|
|
American Society of Anesthesiologists (ASA)-physical state (2-5)
ASA 5
|
5 participants
n=5 Participants
|
|
American Society of Anesthesiologists (ASA)-physical state (2-5)
Missing
|
5 participants
n=5 Participants
|
|
ECOG (Eastern Cooperative Oncology Group) performance status (0-4)
ECOG 0
|
2 participants
n=5 Participants
|
|
ECOG (Eastern Cooperative Oncology Group) performance status (0-4)
ECOG 1
|
33 participants
n=5 Participants
|
|
ECOG (Eastern Cooperative Oncology Group) performance status (0-4)
ECOG 2
|
40 participants
n=5 Participants
|
|
ECOG (Eastern Cooperative Oncology Group) performance status (0-4)
ECOG 3
|
36 participants
n=5 Participants
|
|
ECOG (Eastern Cooperative Oncology Group) performance status (0-4)
ECOG 4
|
14 participants
n=5 Participants
|
|
ECOG (Eastern Cooperative Oncology Group) performance status (0-4)
Missing
|
6 participants
n=5 Participants
|
|
Reason for the use of Instanyl
No previous BTP medication
|
86 participants
n=5 Participants
|
|
Reason for the use of Instanyl
Previous BTP medic./Insufficient efficacy
|
32 participants
n=5 Participants
|
|
Reason for the use of Instanyl
Previous BTP medic./Insufficient speed of action
|
32 participants
n=5 Participants
|
|
Reason for the use of Instanyl
Previous BTP medic./Insufficient handling
|
12 participants
n=5 Participants
|
|
Reason for the use of Instanyl
Previous BTP medic./Insufficient tolerability
|
6 participants
n=5 Participants
|
|
Reason for the use of Instanyl
Previous BTP medic./Other reasons
|
7 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: during therapy with Instanyl (planned: 28 days)Population: Patients included and treated (without imputation of missing values), intention to treat. All patients included
Initially prescribed dose/ most efficient single dose of Instanyl at study end
Outcome measures
| Measure |
Study Start
n=131 Participants
|
Study End
n=116 Participants
|
|---|---|---|
|
Dose of Instanyl
400 µg
|
0 participants
|
1 participants
|
|
Dose of Instanyl
50 µg
|
75 participants
|
30 participants
|
|
Dose of Instanyl
100 µg
|
50 participants
|
69 participants
|
|
Dose of Instanyl
200 µg
|
5 participants
|
15 participants
|
|
Dose of Instanyl
Missing
|
1 participants
|
1 participants
|
PRIMARY outcome
Timeframe: before and after therapy with Instanyl (first/last visit)Population: All patients included and treated, intention to treat, missing values not imputed. All patients with valid values ('as observed'). N= number of valid cases.
Scale: 0=no, 1=mild, 2=moderate, 3=strong, 4=very strong, 5=extreme
Outcome measures
| Measure |
Study Start
n=131 Participants
|
Study End
n=116 Participants
|
|---|---|---|
|
Physician: Degree of Maximum Pain Intensity During the Last Days/ Since the Last Examination
Persistent pain (IV: N= 126, LV: N= 116)
|
2.3 units on a scale
Standard Deviation 1.1
|
1.6 units on a scale
Standard Deviation 0.9
|
|
Physician: Degree of Maximum Pain Intensity During the Last Days/ Since the Last Examination
Breakthrough pain (IV: N= 126, LV: N= 115)
|
3.5 units on a scale
Standard Deviation 0.9
|
1.8 units on a scale
Standard Deviation 1.2
|
PRIMARY outcome
Timeframe: before and after therapy with Instanyl (first/last visit)Population: All patients included and treated, intention to treat, missing values not imputed. All patients with valid values ('as observed')= N.
Scale: 1=very good, 2=good, 3=satisfactory, 4=poor, 5=very poor, 6=insufficient
Outcome measures
| Measure |
Study Start
n=45 Participants
|
Study End
n=116 Participants
|
|---|---|---|
|
Physician: Assessment of Breakthrough Pain Therapy (Initial Visit: Previous/Last Visit: Instanyl)
speed of action (FV: N= 45, LV: N= 114)
|
4.0 units on a scale
Standard Deviation 1.3
|
1.7 units on a scale
Standard Deviation 0.8
|
|
Physician: Assessment of Breakthrough Pain Therapy (Initial Visit: Previous/Last Visit: Instanyl)
strength of action (FV: N= 45, LV: N= 115)
|
4.0 units on a scale
Standard Deviation 1.3
|
1.8 units on a scale
Standard Deviation 0.9
|
|
Physician: Assessment of Breakthrough Pain Therapy (Initial Visit: Previous/Last Visit: Instanyl)
tolerability (FV: N= 44, LV: N= 113)
|
3.0 units on a scale
Standard Deviation 1.4
|
1.7 units on a scale
Standard Deviation 0.6
|
|
Physician: Assessment of Breakthrough Pain Therapy (Initial Visit: Previous/Last Visit: Instanyl)
safety (FV: N= 45, LV: N= 114)
|
2.9 units on a scale
Standard Deviation 1.2
|
1.7 units on a scale
Standard Deviation 0.6
|
|
Physician: Assessment of Breakthrough Pain Therapy (Initial Visit: Previous/Last Visit: Instanyl)
handling (FV: N= 45, LV: N= 115)
|
3.4 units on a scale
Standard Deviation 1.4
|
2.1 units on a scale
Standard Deviation 1.2
|
|
Physician: Assessment of Breakthrough Pain Therapy (Initial Visit: Previous/Last Visit: Instanyl)
patient satisfaction (FV: N= 45, LV: N= 116)
|
4.2 units on a scale
Standard Deviation 1.3
|
1.9 units on a scale
Standard Deviation 1.1
|
PRIMARY outcome
Timeframe: after therapy with Instanyl (planned: 4 weeks)Population: Patients included and treated with valid data (without imputation of missing values), intention to treat. All patients with valid values at last visit. N= number of valid cases (=110). From the 116 participants analyzed, only 110 participants had valid values at the last visit.
5=completely, 4=for the most part, 3=partially, 2= more or less, 1=rather not, 0=not at all
Outcome measures
| Measure |
Study Start
n=116 Participants
|
Study End
|
|---|---|---|
|
Physician: To What Extent Did Your Expectations in Instanyl Have Met? (Last Visit)
|
4.4 units on a scale
Standard Deviation 0.7
|
—
|
PRIMARY outcome
Timeframe: after therapy with Instanyl (at last visit)Population: All patients included and treated, intention to treat, missing values not imputed. All patients with valid values ('as observed'). N=number of valid cases.
Scale: -3= very much improved, -2= much improved, -1= improved, 0= comparable, 1= worsened, 2= much worsened ,3= very much worsened
Outcome measures
| Measure |
Study Start
n=116 Participants
|
Study End
|
|---|---|---|
|
Physician: To What Extent Changes Have Occurred Induced by the Treatment of Breakthrough Pain With Instanyl With Respect to ... (at Last Visit)
Nursing and support efforts (N= 113)
|
-1.2 units on a scale
Standard Deviation 1.0
|
—
|
|
Physician: To What Extent Changes Have Occurred Induced by the Treatment of Breakthrough Pain With Instanyl With Respect to ... (at Last Visit)
Autonomy of the patient (N= 113)
|
-1.5 units on a scale
Standard Deviation 0.9
|
—
|
|
Physician: To What Extent Changes Have Occurred Induced by the Treatment of Breakthrough Pain With Instanyl With Respect to ... (at Last Visit)
Pain-related impairment in everyday life (N= 113)
|
-1.6 units on a scale
Standard Deviation 0.9
|
—
|
|
Physician: To What Extent Changes Have Occurred Induced by the Treatment of Breakthrough Pain With Instanyl With Respect to ... (at Last Visit)
Quality of patient's life (N= 112)
|
-1.5 units on a scale
Standard Deviation 0.9
|
—
|
|
Physician: To What Extent Changes Have Occurred Induced by the Treatment of Breakthrough Pain With Instanyl With Respect to ... (at Last Visit)
Extent of use of other medical services (N= 112)
|
-1.1 units on a scale
Standard Deviation 1.0
|
—
|
PRIMARY outcome
Timeframe: before and after therapy with Instanyl (first/last visit)Population: All patients included and treated, intention to treat, missing values not imputed. All patients with valid values ('as observed'). N= number of valid cases.
Scale: 0=no, 1=low, 2=medium, 3=high
Outcome measures
| Measure |
Study Start
n=131 Participants
|
Study End
n=116 Participants
|
|---|---|---|
|
Physician: What is the Current Treatment Needs of Your Patient Regarding ...
Problems with organization of care (N=129, N=112)
|
1.1 units on a scale
Standard Deviation 1.0
|
0.8 units on a scale
Standard Deviation 0.8
|
|
Physician: What is the Current Treatment Needs of Your Patient Regarding ...
persistent pain (IV: N=131, LV: N=112)
|
2.0 units on a scale
Standard Deviation 0.8
|
1.3 units on a scale
Standard Deviation 0.8
|
|
Physician: What is the Current Treatment Needs of Your Patient Regarding ...
breakthrough pain (IV: N=130, LV: N=111)
|
2.5 units on a scale
Standard Deviation 0.6
|
1.2 units on a scale
Standard Deviation 0.8
|
|
Physician: What is the Current Treatment Needs of Your Patient Regarding ...
nausea (IV: N=130, LV: N=112)
|
1.5 units on a scale
Standard Deviation 0.8
|
0.9 units on a scale
Standard Deviation 0.8
|
|
Physician: What is the Current Treatment Needs of Your Patient Regarding ...
vomiting (IV: N=130, LV: N=112)
|
1.2 units on a scale
Standard Deviation 0.9
|
0.7 units on a scale
Standard Deviation 0.7
|
|
Physician: What is the Current Treatment Needs of Your Patient Regarding ...
dyspnoea (IV: N=130, LV: N=111)
|
1.0 units on a scale
Standard Deviation 0.9
|
0.7 units on a scale
Standard Deviation 0.8
|
|
Physician: What is the Current Treatment Needs of Your Patient Regarding ...
constipation (IV: N=129, LV: N=112)
|
1.2 units on a scale
Standard Deviation 0.9
|
0.8 units on a scale
Standard Deviation 0.8
|
|
Physician: What is the Current Treatment Needs of Your Patient Regarding ...
weakness (IV: N=129, LV: N=112)
|
2.0 units on a scale
Standard Deviation 0.8
|
1.4 units on a scale
Standard Deviation 1.0
|
|
Physician: What is the Current Treatment Needs of Your Patient Regarding ...
poor appetite (IV: N=131, LV: N=112)
|
1.8 units on a scale
Standard Deviation 0.9
|
1.4 units on a scale
Standard Deviation 1.0
|
|
Physician: What is the Current Treatment Needs of Your Patient Regarding ...
tiredness (IV: N=130, LV: N=112)
|
1.8 units on a scale
Standard Deviation 0.8
|
1.4 units on a scale
Standard Deviation 0.9
|
|
Physician: What is the Current Treatment Needs of Your Patient Regarding ...
efforts due to wounds/decubitus (N=130, N=112)
|
1.0 units on a scale
Standard Deviation 1.0
|
0.8 units on a scale
Standard Deviation 0.9
|
|
Physician: What is the Current Treatment Needs of Your Patient Regarding ...
need for assistance (IV: N=130, LV: N=111)
|
1.8 units on a scale
Standard Deviation 0.9
|
1.3 units on a scale
Standard Deviation 0.9
|
|
Physician: What is the Current Treatment Needs of Your Patient Regarding ...
depressiveness (IV: N=129, LV: N=111)
|
1.6 units on a scale
Standard Deviation 0.8
|
1.1 units on a scale
Standard Deviation 0.8
|
|
Physician: What is the Current Treatment Needs of Your Patient Regarding ...
anxiety (IV: N=130, LV: N=112)
|
1.6 units on a scale
Standard Deviation 0.8
|
1.1 units on a scale
Standard Deviation 0.7
|
|
Physician: What is the Current Treatment Needs of Your Patient Regarding ...
tension (IV: N=130, LV: N=112)
|
1.6 units on a scale
Standard Deviation 0.9
|
1.2 units on a scale
Standard Deviation 0.8
|
|
Physician: What is the Current Treatment Needs of Your Patient Regarding ...
disorientation, confusion (IV: N=130, LV: N=111)
|
0.6 units on a scale
Standard Deviation 0.8
|
0.5 units on a scale
Standard Deviation 0.7
|
|
Physician: What is the Current Treatment Needs of Your Patient Regarding ...
Overburdening family/environment N=129, N=112
|
1.4 units on a scale
Standard Deviation 1.0
|
1.0 units on a scale
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: after therapy with Instanyl (planned: 4 weeks)Population: Patients included and treated with valid data (without imputation of missing values), intention to treat. All patients with valid values at last visit. N= number of valid cases (=114). From the 116 participants analyzed, only 114 participants had valid values at the last visit.
0=no reduction, 1=slight, 2=medium, 3=strong, 4=very strong, 5=complete
Outcome measures
| Measure |
Study Start
n=116 Participants
|
Study End
|
|---|---|---|
|
Physician: Degree of Relief of Breakthrough Pain Achieved by Instanyl at Study End
|
3.4 units on a scale
Standard Deviation 1.0
|
—
|
SECONDARY outcome
Timeframe: initial visit (before start of therapy with Instanyl)Population: All patients included and treated who filled in the patient's documentation, intention to treat, missing values not imputed. All patients with valid values ('as observed'). N= number of valid cases (= 91). From the 95 participants analyzed, only 91 participants had valid values at the last visit.
Outcome measures
| Measure |
Study Start
n=95 Participants
|
Study End
|
|---|---|---|
|
Patient: How Many Episodes of Pain You Experience on Average?
|
3.0 episodes per day
Standard Deviation 2.2
|
—
|
SECONDARY outcome
Timeframe: initial visit (before start of therapy with Instanyl)Population: All patients included and treated who filled in the patient's documentation, intention to treat, missing values not imputed. All patients with valid values ('as observed') =N.
0=no pain, 10= most intense pain imaginable
Outcome measures
| Measure |
Study Start
n=95 Participants
|
Study End
|
|---|---|---|
|
Patient: Description of Pain at Initial Visit
Persistent pain in the last 24 hrs on average N=94
|
5.6 units on a scale
Standard Deviation 2.3
|
—
|
|
Patient: Description of Pain at Initial Visit
Pain during the last pain attacks maximally N=93
|
8.3 units on a scale
Standard Deviation 1.4
|
—
|
|
Patient: Description of Pain at Initial Visit
Pain intensity bearable N= 94
|
4.0 units on a scale
Standard Deviation 1.5
|
—
|
SECONDARY outcome
Timeframe: before and after therapy with Instanyl (first/last visit)Population: All patients included and treated who filled in the patient's documentation, intention to treat, missing values not imputed. All patients with valid values ('as observed'). N= number of valid cases. * Initial Visit N=94 * Last Visit N=83
Scale: 1=very bad, 2=bad, 3=mediocre, 4=good, 5=very good
Outcome measures
| Measure |
Study Start
n=95 Participants
|
Study End
n=83 Participants
|
|---|---|---|
|
Patient: How do You Feel Today?
|
2.2 units on a scale
Standard Deviation 0.7
|
3.3 units on a scale
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: before and after therapy with Instanyl (first/last visit)Population: All patients included and treated who filled in the patient's documentation, intention to treat, missing values not imputed. All patients with valid values ('as observed'). N= number of valid cases. * Initial Visit N=94 * Last Visit N=83
Scale: 0=not at all, 10=completely
Outcome measures
| Measure |
Study Start
n=95 Participants
|
Study End
n=83 Participants
|
|---|---|---|
|
Patient: To What Extent Your Present Condition is Affected by Your Pain Attacks?
|
7.6 units on a scale
Standard Deviation 1.7
|
3.8 units on a scale
Standard Deviation 2.3
|
SECONDARY outcome
Timeframe: before and after therapy with Instanyl (first/last visit)Population: All patients included and treated who filled in the patient's documentation, intention to treat, missing values not imputed. All patients with valid values ('as observed'). N= number of valid cases. * Initial Visit N=92 * Last Visit N= 80
Scale: 0=no impairment, 70=complete impairment
Outcome measures
| Measure |
Study Start
n=95 Participants
|
Study End
n=83 Participants
|
|---|---|---|
|
Patient: Modified Pain Disability Index (mPDI) - Sum - Score (Complete Questionnaires Only)
|
51.9 units on a scale
Standard Deviation 11.4
|
29.1 units on a scale
Standard Deviation 16.3
|
SECONDARY outcome
Timeframe: before and after therapy with Instanyl (first/last visit)Population: All patients included and treated who filled in the patient's documentation, intention to treat, missing values not imputed. All patients with valid values ('as observed'). N= number of valid cases. * Initial Visit N=93 * Last Visit N=82
Scale: 0=complete impairment, 43=no impairment
Outcome measures
| Measure |
Study Start
n=95 Participants
|
Study End
n=83 Participants
|
|---|---|---|
|
Patient: Quality-of-Life-Impairment by Pain =QLIP - Sum - Score (Complete Questionnaires Only)
|
12.3 units on a scale
Standard Deviation 6.6
|
24.7 units on a scale
Standard Deviation 7.3
|
SECONDARY outcome
Timeframe: before and after therapy with Instanyl (first/last visit)Population: All patients included and treated who filled in the patient's documentation, intention to treat, missing values not imputed. All patients with valid values ('as observed'). N= number of valid cases.
0= conspicuous ≤20 1= inconspicuous \>20
Outcome measures
| Measure |
Study Start
n=95 Participants
|
Study End
n=83 Participants
|
|---|---|---|
|
Patient: Quality-of-Life-Impairment by Pain =QLIP - Sum - Score (Complete Questionnaires Only) Conspicuous ≤20
QLIP - score (classified):QLIP conspicuous (≤20)
|
80 participants
|
21 participants
|
|
Patient: Quality-of-Life-Impairment by Pain =QLIP - Sum - Score (Complete Questionnaires Only) Conspicuous ≤20
QLIP - score (classified):QLIP inconspicuous (>20)
|
13 participants
|
61 participants
|
|
Patient: Quality-of-Life-Impairment by Pain =QLIP - Sum - Score (Complete Questionnaires Only) Conspicuous ≤20
Missing
|
2 participants
|
1 participants
|
SECONDARY outcome
Timeframe: before and after therapy with Instanyl (first/last visit)Population: All patients included and treated who filled in the patient's documentation, intention to treat, missing values not imputed. All patients with valid values ('as observed'). N= number of valid cases. * Initial Visit N=93 * Last Visit N=81
Scale: 0=worst, 5=best
Outcome measures
| Measure |
Study Start
n=95 Participants
|
Study End
n=83 Participants
|
|---|---|---|
|
Patient: Marburg Questionnaire on Habitual Health (MQHH): Sum - Score (Complete Questionnaires Only)
|
1.2 units on a scale
Standard Deviation 1.0
|
2.2 units on a scale
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: before and after therapy with Instanyl (first/last visit)Population: All patients included and treated who filled in the patient's documentation, intention to treat, missing values not imputed. All patients with valid values ('as observed'). N= number of valid cases.
conspicuous score \<1.5 inconspicuous score ≥1.5
Outcome measures
| Measure |
Study Start
n=95 Participants
|
Study End
n=83 Participants
|
|---|---|---|
|
Patient: Marburg Questionnaire on Habitual Health (MQHH): Sum - Score (Complete Questionnaires Only) Conspicuous <1.5
MQHH - score (classified):conspicuous:score <1.5
|
62 participants
|
24 participants
|
|
Patient: Marburg Questionnaire on Habitual Health (MQHH): Sum - Score (Complete Questionnaires Only) Conspicuous <1.5
MQHH - score (classified):inconspicuous:score ≥1.5
|
31 participants
|
57 participants
|
|
Patient: Marburg Questionnaire on Habitual Health (MQHH): Sum - Score (Complete Questionnaires Only) Conspicuous <1.5
Missing
|
2 participants
|
2 participants
|
SECONDARY outcome
Timeframe: after therapy with Instanyl (planned: 4 weeks)Population: Patients included and treated who filled in the patient's documentation with valid data (without imputation of missing values), intention to treat. All patients with valid values at last visit. N= number of valid cases (80). From the 83 participants analyzed, only 80 participants had valid values at the last visit.
0=no reduction, 1=slight, 2=medium, 3=strong, 4=very strong, 5=complete
Outcome measures
| Measure |
Study Start
n=83 Participants
|
Study End
|
|---|---|---|
|
Patient: Degree of Relief of Breakthrough Pain Achieved by Instanyl at Study End
|
3.4 units on a scale
Standard Deviation 1.0
|
—
|
SECONDARY outcome
Timeframe: before and after therapy with Instanyl (first/last visit)Population: All patients included and treated who filled in the patient's documentation, intention to treat, missing values not imputed. All patients with valid values ('as observed').
Scale: 1=very good, 2=good, 3=satisfactory, 4=poor, 5=very poor, 6=insufficient
Outcome measures
| Measure |
Study Start
n=34 Participants
|
Study End
n=83 Participants
|
|---|---|---|
|
Patient: Assessment of Breakthrough Pain Therapy (Initial Visit: Previous/Last Visit: Instanyl)
speed of action (FV: N=33, LV: N=82)
|
4.1 units on a scale
Standard Deviation 1.1
|
2.0 units on a scale
Standard Deviation 1.0
|
|
Patient: Assessment of Breakthrough Pain Therapy (Initial Visit: Previous/Last Visit: Instanyl)
strength of action (FV: N=33, LV: N=82)
|
3.9 units on a scale
Standard Deviation 1.2
|
2.0 units on a scale
Standard Deviation 1.1
|
|
Patient: Assessment of Breakthrough Pain Therapy (Initial Visit: Previous/Last Visit: Instanyl)
tolerability (FV: N=33, LV: N=82)
|
3.2 units on a scale
Standard Deviation 1.1
|
2.0 units on a scale
Standard Deviation 1.1
|
|
Patient: Assessment of Breakthrough Pain Therapy (Initial Visit: Previous/Last Visit: Instanyl)
handling (FV: N=33, LV: N=80)
|
3.4 units on a scale
Standard Deviation 1.3
|
2.0 units on a scale
Standard Deviation 1.0
|
|
Patient: Assessment of Breakthrough Pain Therapy (Initial Visit: Previous/Last Visit: Instanyl)
total satisfaction (FV: N=NA, LV: N=82)
|
NA units on a scale
Standard Deviation NA
no participants contributed data
|
2.0 units on a scale
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: after therapy with Instanyl (planned: 4 weeks)Population: Patients included and treated who filled in the patient's documentation with valid data (without imputation of missing values), intention to treat. All patients with valid values at last visit. N= number of valid cases.
5=completely, 4=for the most part, 3=partially, 2=more or less, 1=rather not, 0=not at all
Outcome measures
| Measure |
Study Start
n=83 Participants
|
Study End
|
|---|---|---|
|
Patient: To What Extent Did Your Expectations in Instanyl Have Met With Respect to ... (Last Visit)
speed of action (N=79)
|
4.2 units on a scale
Standard Deviation 0.8
|
—
|
|
Patient: To What Extent Did Your Expectations in Instanyl Have Met With Respect to ... (Last Visit)
strength of action (N=80)
|
4.2 units on a scale
Standard Deviation 0.9
|
—
|
|
Patient: To What Extent Did Your Expectations in Instanyl Have Met With Respect to ... (Last Visit)
tolerability (N=78)
|
4.3 units on a scale
Standard Deviation 0.7
|
—
|
|
Patient: To What Extent Did Your Expectations in Instanyl Have Met With Respect to ... (Last Visit)
handling (N=79)
|
4.2 units on a scale
Standard Deviation 0.9
|
—
|
|
Patient: To What Extent Did Your Expectations in Instanyl Have Met With Respect to ... (Last Visit)
total satisfaction (N=80)
|
4.2 units on a scale
Standard Deviation 0.9
|
—
|
SECONDARY outcome
Timeframe: after therapy with Instanyl (at last visit)Population: All patients included and treated who filled in the patient's documentation, intention to treat, missing values not imputed. All patients with valid values ('as observed'). N= number of valid cases (=81). From the 83 participants analyzed, only 81 participants had valid values at the last visit.
Scale: -3= very much improved, -2= much improved, -1= improved , 0= comparable, 1= worsened, 2= much worsened, 3= very much worsened
Outcome measures
| Measure |
Study Start
n=83 Participants
|
Study End
|
|---|---|---|
|
Patient: To What Extent Changes Have Occurred Induced by the Treatment of Breakthrough Pain With Instanyl With Respect to ...(at Last Visit)
Nursing and support efforts (N= 81)
|
-1.0 units on a scale
Standard Deviation 0.9
|
—
|
|
Patient: To What Extent Changes Have Occurred Induced by the Treatment of Breakthrough Pain With Instanyl With Respect to ...(at Last Visit)
Autonomy of the patient (N= 81)
|
-1.4 units on a scale
Standard Deviation 0.8
|
—
|
|
Patient: To What Extent Changes Have Occurred Induced by the Treatment of Breakthrough Pain With Instanyl With Respect to ...(at Last Visit)
Pain-related impairment in everyday life (N= 81)
|
-1.3 units on a scale
Standard Deviation 0.8
|
—
|
|
Patient: To What Extent Changes Have Occurred Induced by the Treatment of Breakthrough Pain With Instanyl With Respect to ...(at Last Visit)
Quality of patient's life (N= 81)
|
-1.4 units on a scale
Standard Deviation 0.8
|
—
|
SECONDARY outcome
Timeframe: after therapy with Instanyl (planned: 4 weeks)Population: Patients included and treated with caregiver documentation (without imputation of missing values), ITT. All patients with valid values at last visit. N= number of valid cases (=67). From the 70 participants analyzed, only 67 participants had valid values at the last visit.
0=no reduction, 1=slight, 2=medium, 3=strong, 4=very strong, 5=complete
Outcome measures
| Measure |
Study Start
n=70 Participants
|
Study End
|
|---|---|---|
|
Caregiver: Degree of Relief of Breakthrough Pain Achieved by Instany at Study End
|
3.3 units on a scale
Standard Deviation 1.0
|
—
|
SECONDARY outcome
Timeframe: after therapy with Instanyl (first/last visit)Population: Patients included and treated with caregiver documentation (without imputation of missing values), intention to treat. All patients with valid values ('as observed'). N= number of valid cases.
Scale: 1=very good, 2=good, 3=satisfactory, 4=poor, 5=very poor, 6=insufficient
Outcome measures
| Measure |
Study Start
n=70 Participants
|
Study End
|
|---|---|---|
|
Caregiver: Assessment of Breakthrough Pain Therapy by Instanyl (Last Visit)
speed of action (N=69)
|
2.2 units on a scale
Standard Deviation 0.8
|
—
|
|
Caregiver: Assessment of Breakthrough Pain Therapy by Instanyl (Last Visit)
strength of action (N=69)
|
2.1 units on a scale
Standard Deviation 0.9
|
—
|
|
Caregiver: Assessment of Breakthrough Pain Therapy by Instanyl (Last Visit)
tolerability (N=69)
|
1.9 units on a scale
Standard Deviation 0.8
|
—
|
|
Caregiver: Assessment of Breakthrough Pain Therapy by Instanyl (Last Visit)
safety (N=68)
|
2.0 units on a scale
Standard Deviation 0.8
|
—
|
|
Caregiver: Assessment of Breakthrough Pain Therapy by Instanyl (Last Visit)
handling (N=69)
|
2.2 units on a scale
Standard Deviation 1.1
|
—
|
|
Caregiver: Assessment of Breakthrough Pain Therapy by Instanyl (Last Visit)
patient satisfaction (N=68)
|
2.1 units on a scale
Standard Deviation 1.0
|
—
|
SECONDARY outcome
Timeframe: after therapy with Instanyl (at last visit)Population: Patients included and treated with caregiver documentation (without imputation of missing values), ITT. All patients with valid values ('as observed') =N.
Scale: -3= very much improved, -2= much improved, -1= improved , 0= comparable, 1= worsened, 2= much worsened, 3= very much worsened
Outcome measures
| Measure |
Study Start
n=70 Participants
|
Study End
|
|---|---|---|
|
Caregiver: To What Extent Changes Have Occurred Induced by the Treatment of Breakthrough Pain With Instanyl With Respect to ... (at Last Visit)
Nursing and support efforts (N= 69)
|
-0.8 units on a scale
Standard Deviation 0.8
|
—
|
|
Caregiver: To What Extent Changes Have Occurred Induced by the Treatment of Breakthrough Pain With Instanyl With Respect to ... (at Last Visit)
Autonomy of the patient (N= 69)
|
-1.2 units on a scale
Standard Deviation 0.8
|
—
|
|
Caregiver: To What Extent Changes Have Occurred Induced by the Treatment of Breakthrough Pain With Instanyl With Respect to ... (at Last Visit)
Pain-related impairment in everyday life (N= 69)
|
-1.3 units on a scale
Standard Deviation 0.8
|
—
|
|
Caregiver: To What Extent Changes Have Occurred Induced by the Treatment of Breakthrough Pain With Instanyl With Respect to ... (at Last Visit)
Quality of patient's life (N= 68)
|
-1.3 units on a scale
Standard Deviation 0.7
|
—
|
|
Caregiver: To What Extent Changes Have Occurred Induced by the Treatment of Breakthrough Pain With Instanyl With Respect to ... (at Last Visit)
Extent of use of other medical services (N= 69)
|
-0.9 units on a scale
Standard Deviation 0.8
|
—
|
SECONDARY outcome
Timeframe: after therapy with Instanyl (last visit)Population: Patients included and treated with caregiver documentation (without imputation of missing values), ITT. All patients with valid values ('as observed'). N= number of valid cases
Scale: -3= very much less, -2= much less, -1= less, 0=comparable, 1= more, 2= much more, 3= very much more
Outcome measures
| Measure |
Study Start
n=70 Participants
|
Study End
|
|---|---|---|
|
Caregiver: To What Extent the Treatment Needs of Your Patient Has Changed by the Use of Instanyl Regarding ...
persistent pain (N=68)
|
-1.2 units on a scale
Standard Deviation 0.9
|
—
|
|
Caregiver: To What Extent the Treatment Needs of Your Patient Has Changed by the Use of Instanyl Regarding ...
breakthrough pain (N=68)
|
-1.8 units on a scale
Standard Deviation 0.8
|
—
|
|
Caregiver: To What Extent the Treatment Needs of Your Patient Has Changed by the Use of Instanyl Regarding ...
nausea (N=68)
|
-1.1 units on a scale
Standard Deviation 1.0
|
—
|
|
Caregiver: To What Extent the Treatment Needs of Your Patient Has Changed by the Use of Instanyl Regarding ...
vomiting (N=65)
|
-0.9 units on a scale
Standard Deviation 1.0
|
—
|
|
Caregiver: To What Extent the Treatment Needs of Your Patient Has Changed by the Use of Instanyl Regarding ...
dyspnoea (N=66)
|
-1.1 units on a scale
Standard Deviation 1.1
|
—
|
|
Caregiver: To What Extent the Treatment Needs of Your Patient Has Changed by the Use of Instanyl Regarding ...
constipation (N=68)
|
-0.8 units on a scale
Standard Deviation 1.1
|
—
|
|
Caregiver: To What Extent the Treatment Needs of Your Patient Has Changed by the Use of Instanyl Regarding ...
weakness (N=68)
|
-0.7 units on a scale
Standard Deviation 0.9
|
—
|
|
Caregiver: To What Extent the Treatment Needs of Your Patient Has Changed by the Use of Instanyl Regarding ...
poor appetite (N=68)
|
-0.7 units on a scale
Standard Deviation 1.0
|
—
|
|
Caregiver: To What Extent the Treatment Needs of Your Patient Has Changed by the Use of Instanyl Regarding ...
tiredness (N=67)
|
-0.8 units on a scale
Standard Deviation 1.0
|
—
|
|
Caregiver: To What Extent the Treatment Needs of Your Patient Has Changed by the Use of Instanyl Regarding ...
efforts due to wounds/decubitus (N=68)
|
-0.8 units on a scale
Standard Deviation 1.0
|
—
|
|
Caregiver: To What Extent the Treatment Needs of Your Patient Has Changed by the Use of Instanyl Regarding ...
need for assistance in daily activities (N=68)
|
-1.1 units on a scale
Standard Deviation 1.0
|
—
|
|
Caregiver: To What Extent the Treatment Needs of Your Patient Has Changed by the Use of Instanyl Regarding ...
depressiveness (N=67)
|
-1.0 units on a scale
Standard Deviation 1.1
|
—
|
|
Caregiver: To What Extent the Treatment Needs of Your Patient Has Changed by the Use of Instanyl Regarding ...
anxiety (N=67)
|
-1.2 units on a scale
Standard Deviation 1.1
|
—
|
|
Caregiver: To What Extent the Treatment Needs of Your Patient Has Changed by the Use of Instanyl Regarding ...
tension (N=67)
|
-1.1 units on a scale
Standard Deviation 1.0
|
—
|
|
Caregiver: To What Extent the Treatment Needs of Your Patient Has Changed by the Use of Instanyl Regarding ...
disorientation, confusion (N=67)
|
-0.9 units on a scale
Standard Deviation 1.1
|
—
|
|
Caregiver: To What Extent the Treatment Needs of Your Patient Has Changed by the Use of Instanyl Regarding ...
Problems with the organization of care (N=68)
|
-1.0 units on a scale
Standard Deviation 1.1
|
—
|
|
Caregiver: To What Extent the Treatment Needs of Your Patient Has Changed by the Use of Instanyl Regarding ...
Overburdening family/environment (N=68)
|
-1.2 units on a scale
Standard Deviation 1.1
|
—
|
Adverse Events
All Patients Treated
Serious adverse events
| Measure |
All Patients Treated
n=131 participants at risk
|
|---|---|
|
General disorders
Death
|
13.7%
18/131 • Number of events 18 • First until last visit (planned 4 weeks)
Patients included and treated with at least one application of Instanyl
|
|
Surgical and medical procedures
Osteosynthesis
|
0.76%
1/131 • Number of events 1 • First until last visit (planned 4 weeks)
Patients included and treated with at least one application of Instanyl
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place