Efficacy and Tolerability of Intranasal Fentanyl Spray fo... | NCT00994760

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Label	Type	Description	Intervention Names
GENISIS			Drug: Instanyl (Intranasal Fentanyl)

Name	Type	Description	Arm Group Labels	Other Names
Instanyl (Intranasal Fentanyl)	Drug	This was an observational study. Therefore, the physician decided about dosage according to individual needs.	GENISIS

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Dose of Instanyl	Initially prescribed dose/ most efficient single dose of Instanyl at study end	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	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	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	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	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	before and after therapy with Instanyl (first/last visit)

Secondary Outcomes

Measure	Description	Time Frame
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	after therapy with Instanyl (planned: 4 weeks)
Patient: How Many Episodes of Pain You Experience on Average?

Eligibility Module

Name	Affiliation	Role
Dr. Thomas D. Bethke, PhD; MD	Nycomed Deutschland GmbH, 78467 Konstanz, Germany	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Nycomed Deutschland GmbH		Aachen		52074	Germany
Nycomed Deutschland GmbH

Results Section

Participant Flow Module

ID	Title	Description
FG000	GENISIS	Intranasal Fentanyl Spray

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age Continuous

Number of valid cases = 130. Number of valid cases = patients with data available.

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00062.1± 12.1

Sex/Gender, Customized

Number

participants

Title

Denominators

Categories

Female

Title	Measurements
	BG00060

Male

Title	Measurements
	BG000

Body Mass Index (BMI)

Number of valid cases = 126. Number of valid cases = patients with data available.

Mean

Standard Deviation

kgˆm2

Title

Denominators

Categories

Title	Measurements
	BG00023.2± 4.4

Tumor diagnosis (malignant neop-lasms ICD10)

Number

percentage of participants

Title

Denominators

Categories

Pain not caused by tumor

Title	Measurements
	BG0002.3

C00-C14 lip, oral cavity and pharynx

Title	Measurements
	BG000

Karnofsky-index

score 0= worst (death) , 100= best (no limitation in health)

Number of valid cases = 125. Number of valid cases = patients with data available.

Mean

Standard Deviation

scores

Title

Denominators

Categories

Title	Measurements
	BG00058.6± 21.6

American Society of Anesthesiologists (ASA)-physical state (2-5)

ASA = physical status.

state 2: patient with slight generalized disease
state 3: patient with severe generalized disease
state 4: life threatening generalized disease
state 5: moribund patient, unlikly to survive without operation

Number

participants

Title

Denominators

Categories

ASA 2

Title	Measurements
	BG00022

ASA 3

Title	Measurements

ECOG (Eastern Cooperative Oncology Group) performance status (0-4)

ECOG 0 (fully active) ECOG 1 (restricted in strenuous activity, ambulatory) ECOG 2 (ambulatory, up and about more than 50% of waking hours ECOG 3 (limited selfcare, confined to bed > 50% of waking hours ECOG 4 (completely disabled, no selfcare)

Number

participants

Title

Denominators

Categories

ECOG 0

Title	Measurements
	BG0002

ECOG 1

Title	Measurements

Reason for the use of Instanyl

(multiple reasons possible)

Number

participants

Title

Denominators

Categories

No previous BTP medication

Title	Measurements
	BG00086

Previous BTP medic./Insufficient efficacy

Title	Measurements
	BG000

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Dose of Instanyl

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

Patients included and treated (without imputation of missing values), intention to treat.

All patients included

Posted

Number

participants

during therapy with Instanyl (planned: 28 days)

ID	Title	Description
OG000	Study Start
OG001	Study End

Units	Counts
Participants	OG000131 OG001116

Title

Denominators

Categories

50 µg

Title	Measurements
	OG00075 OG00130

100 µg

Title	Measurements
	OG000

Primary

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

All patients included and treated, intention to treat, missing values not imputed.

All patients with valid values ('as observed'). N= number of valid cases.

Posted

Mean

Standard Deviation

units on a scale

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

ID	Title	Description
OG000	Initial Visit
OG001	Last Visit

Units	Counts
Participants	OG000

Secondary

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

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.

Posted

Mean

Standard Deviation

units on a scale

after therapy with Instanyl (planned: 4 weeks)

ID	Title	Description
OG000	Last Visit

Units	Counts
Participants	OG000116

Primary

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

All patients included and treated, intention to treat, missing values not imputed.

All patients with valid values ('as observed')= N.

Posted

Mean

Standard Deviation

units on a scale

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

ID	Title	Description
OG000	First Visit (FV): Patients With Previous BTP- Medication Only
OG001	Last Visit (LV)

Units	Counts
Participants	OG000

Primary

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

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.

Posted

Mean

Standard Deviation

units on a scale

after therapy with Instanyl (planned: 4 weeks)

ID	Title	Description
OG000	Physician Last Visit (LV)

Units	Counts
Participants	OG000

Primary

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

All patients included and treated, intention to treat, missing values not imputed.

All patients with valid values ('as observed'). N=number of valid cases.

Posted

Mean

Standard Deviation

units on a scale

after therapy with Instanyl (at last visit)

ID	Title	Description
OG000	GENISIS	Intranasal Fentanyl Spray

Units	Counts
Participants	OG000

Primary

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

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

All patients included and treated, intention to treat, missing values not imputed.

All patients with valid values ('as observed'). N= number of valid cases.

Posted

Mean

Standard Deviation

units on a scale

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

ID	Title	Description
OG000	Initial Visit (IV)
OG001	Last Visit (LV)

Units	Counts
Participants	OG000

Secondary

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

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.

Posted

Mean

Standard Deviation

episodes per day

initial visit (before start of therapy with Instanyl)

ID	Title	Description
OG000	First Visit

Units	Counts
Participants	OG00095

Secondary

Patient: Description of Pain at Initial Visit

0=no pain, 10= most intense pain imaginable

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.

Posted

Mean

Standard Deviation

units on a scale

initial visit (before start of therapy with Instanyl)

ID	Title	Description
OG000	Patients at First Visit

Units	Counts
Participants	OG00095

Secondary

Patient: How do You Feel Today?

Scale: 1=very bad, 2=bad, 3=mediocre, 4=good, 5=very good

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

Posted

Mean

Standard Deviation

units on a scale

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

ID	Title	Description
OG000	Initial Visit
OG001	Last Visit

Units	Counts
Participants	OG000

Secondary

Patient: To What Extent Your Present Condition is Affected by Your Pain Attacks?

Scale: 0=not at all, 10=completely

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

Posted

Mean

Standard Deviation

units on a scale

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

ID	Title	Description
OG000	Initial Visit
OG001	Last Visit

Units	Counts
Participants	OG000

Secondary

Patient: Modified Pain Disability Index (mPDI) - Sum - Score (Complete Questionnaires Only)

Scale: 0=no impairment, 70=complete impairment

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

Posted

Mean

Standard Deviation

units on a scale

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

ID	Title	Description
OG000	Initial Visit
OG001	Last Visit

Units	Counts
Participants	OG000

Secondary

Patient: Quality-of-Life-Impairment by Pain =QLIP - Sum - Score (Complete Questionnaires Only)

Scale: 0=complete impairment, 43=no impairment

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

Posted

Mean

Standard Deviation

units on a scale

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

ID	Title	Description
OG000	Initial Visit
OG001	Last Visit

Units	Counts
Participants	OG000

Secondary

Patient: Quality-of-Life-Impairment by Pain =QLIP - Sum - Score (Complete Questionnaires Only) Conspicuous ≤20

0= conspicuous ≤20

1= inconspicuous >20

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.

Posted

Number

participants

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

ID	Title	Description
OG000	Initial Visit
OG001	Last Visit

Units	Counts
Participants	OG000

Secondary

Patient: Marburg Questionnaire on Habitual Health (MQHH): Sum - Score (Complete Questionnaires Only)

Scale: 0=worst, 5=best

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

Posted

Mean

Standard Deviation

units on a scale

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

ID	Title	Description
OG000	Initial Visit
OG001	Last Visit

Units	Counts
Participants	OG000

Secondary

Patient: Marburg Questionnaire on Habitual Health (MQHH): Sum - Score (Complete Questionnaires Only) Conspicuous <1.5

conspicuous score <1.5 inconspicuous score ≥1.5

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.

Posted

Number

participants

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

ID	Title	Description
OG000	Initial Visit
OG001	Last Visit

Units	Counts
Participants	OG000

Secondary

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

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.

Posted

Mean

Standard Deviation

units on a scale

after therapy with Instanyl (planned: 4 weeks)

ID	Title	Description
OG000	Patients at Final Visit

Units	Counts
Participants	OG000

Secondary

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

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').

Posted

Mean

Standard Deviation

units on a scale

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

ID	Title	Description
OG000	First Visit (FV)(Patients With Previous BTP-medication Only)
OG001	Last Visit (LV)

Units	Counts
Participants	OG000

Secondary

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

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.

Posted

Mean

Standard Deviation

units on a scale

after therapy with Instanyl (planned: 4 weeks)

ID	Title	Description
OG000	Patients at Final Visit

Units	Counts
Participants	OG00083

Secondary

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

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.

Posted

Mean

Standard Deviation

units on a scale

after therapy with Instanyl (at last visit)

ID	Title	Description
OG000	Patients at Final Visit

Units	Counts
Participants	OG000

Secondary

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

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.

Posted

Mean

Standard Deviation

units on a scale

after therapy with Instanyl (planned: 4 weeks)

ID	Title	Description
OG000	Caregiver at Final Visit

Units	Counts
Participants	OG000

Secondary

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

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.

Posted

Mean

Standard Deviation

units on a scale

after therapy with Instanyl (first/last visit)

ID	Title	Description
OG000	Caregiver at Final Visit

Units	Counts
Participants	OG00070

Secondary

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

Patients included and treated with caregiver documentation (without imputation of missing values), ITT.

All patients with valid values ('as observed') =N.

Posted

Mean

Standard Deviation

units on a scale

after therapy with Instanyl (at last visit)

ID	Title	Description
OG000	Caregiver at Final Visit

Units	Counts
Participants	OG000

Secondary

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

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

Posted

Mean

Standard Deviation

units on a scale

after therapy with Instanyl (last visit)

ID	Title	Description
OG000	Caregiver at Final Visit

Units	Counts
Participants	OG00070

Title

Denominators

Categories

persistent pain (N=68)

Title	Measurements
	OG000-1.2± 0.9

breakthrough pain (N=68)

Title	Measurements
	OG000-1.8± 0.8

nausea (N=68)

Title	Measurements
	OG000-1.1± 1.0

vomiting (N=65)

Title	Measurements
	OG000-0.9± 1.0

dyspnoea (N=66)

Title	Measurements
	OG000-1.1± 1.1

constipation (N=68)

Title	Measurements
	OG000-0.8± 1.1

weakness (N=68)

Title	Measurements
	OG000-0.7± 0.9

poor appetite (N=68)

Title	Measurements
	OG000-0.7± 1.0

tiredness (N=67)

Title	Measurements
	OG000-0.8± 1.0

efforts due to wounds/decubitus (N=68)

Title	Measurements
	OG000-0.8± 1.0

need for assistance in daily activities (N=68)

Title	Measurements
	OG000-1.1± 1.0

depressiveness (N=67)

Title	Measurements
	OG000-1.0± 1.1

anxiety (N=67)

Title	Measurements
	OG000-1.2± 1.1

tension (N=67)

Title	Measurements
	OG000-1.1± 1.0

disorientation, confusion (N=67)

Title	Measurements
	OG000-0.9± 1.1

Problems with the organization of care (N=68)

Title	Measurements
	OG000-1.0± 1.1

Overburdening family/environment (N=68)

Title	Measurements
	OG000-1.2± 1.1

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Death	General disorders	MedDRA (14.0)	Systematic Assessment		EG00018 events18 affected131 at risk
Osteosynthesis	Surgical and medical procedures	MedDRA (14.0)	Systematic Assessment		EG0001 events1 affected131 at risk

ID	Term
D059390	Breakthrough Pain
D009369	Neoplasms

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms