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

August 27, 2012 updated by: Takeda

A Prospective Non-interventional/Observational Patient Cohort Study on the Efficacy of Intranasal Fentanyl Spray for the Treatment of Breakthrough Pain in Cancer Patients.

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

131

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Aachen, Germany, 52074
        • Nycomed Deutschland GmbH
      • Adendorf, Germany, 21365
        • Nycomed Deutschland GmbH
      • Aichach, Germany, 86551
        • Nycomed Deutschland GmbH
      • Albstadt, Germany, 72458
        • Nycomed Deutschland GmbH
      • Albstadt-Ebingen, Germany, 72458
        • Nycomed Deutschland GmbH
      • Altenkirchen, Germany, 57610
        • Nycomed Deutschland GmbH
      • Aschaffenburg, Germany, 63743
        • Nycomed Deutschland GmbH
      • Aschersleben, Germany, 06449
        • Nycomed Deutschland GmbH
      • Augsburg, Germany, 86150
        • Nycomed Deutschland GmbH
      • Augsburg, Germany, 86163
        • Nycomed Deutschland GmbH
      • Backnang, Germany, 71522
        • Nycomed Deutschland GmbH
      • Bad Bevensen, Germany, 29545
        • Nycomed Deutschland GmbH
      • Bad Dürkheim, Germany, 67098
        • Nycomed Deutschland GmbH
      • Bad Liebenstein, Germany, 36448
        • Nycomed Deutschland GmbH
      • Bad Pyrmont, Germany, 31812
        • Nycomed Deutschland GmbH
      • Bad Schwalbach, Germany, 65307
        • Nycomed Deutschland GmbH
      • Badel, Germany, 39624
        • Nycomed Deutschland GmbH
      • Bademühlen, Germany, 27404
        • Nycomed Deutschland GmbH
      • Bautzen, Germany, 02625
        • Nycomed Deutschland GmbH
      • Berlin, Germany, 10317
        • Nycomed Deutschland GmbH
      • Berlin, Germany, 10409
        • Nycomed Deutschland GmbH
      • Berlin, Germany, 10437
        • Nycomed Deutschland GmbH
      • Berlin, Germany, 10713
        • Nycomed Deutschland GmbH
      • Berlin, Germany, 10715
        • Nycomed Deutschland GmbH
      • Berlin, Germany, 10999
        • Nycomed Deutschland GmbH
      • Berlin, Germany, 12107
        • Nycomed Deutschland GmbH
      • Berlin, Germany, 12627
        • Nycomed Deutschland GmbH
      • Berlin, Germany, 13055
        • Nycomed Deutschland GmbH
      • Bochum, Germany, 44801
        • Nycomed Deutschland GmbH
      • Bonn, Germany, 53177
        • Nycomed Deutschland GmbH
      • Brandenburg/Havel, Germany, 14776
        • Nycomed Deutschland GmbH
      • Braunschweig, Germany, 38100
        • Nycomed Deutschland GmbH
      • Bremen, Germany, 28329
        • Nycomed Deutschland GmbH
      • Brühl, Germany, 50321
        • Nycomed Deutschland GmbH
      • Burg, Germany, 39288
        • Nycomed Deutschland GmbH
      • Burg/Fehmarn, Germany, 23769
        • Nycomed Deutschland GmbH
      • Burscheid, Germany, 51399
        • Nycomed Deutschland GmbH
      • Butzbach, Germany, 35510
        • Nycomed Deutschland GmbH
      • Böblingen, Germany, 71034
        • Nycomed Deutschland GmbH
      • Coburg, Germany, 96450
        • Nycomed Deutschland GmbH
      • Cochem, Germany, 56812
        • Nycomed Deutschland GmbH
      • Cottbus, Germany, 03050
        • Nycomed Deutschland GmbH
      • Cuxhaven, Germany, 27472
        • Nycomed Deutschland GmbH
      • Cuxhaven, Germany, 27474
        • Nycomed Deutschland GmbH
      • Dessau-Roßlau, Germany, 06846
        • Nycomed Deutschland GmbH
      • Dresden, Germany, 01127
        • Nycomed Deutschland GmbH
      • Dresden, Germany, 01307
        • Nycomed Deutschland GmbH
      • Dresden, Germany, 01309
        • Nycomed Deutschland GmbH
      • Duisburg, Germany, 47137
        • Nycomed Deutschland GmbH
      • Düsseldorf, Germany, 40589
        • Nycomed Deutschland GmbH
      • Essen, Germany, 45326
        • Nycomed Deutschland GmbH
      • Etzenricht, Germany, 92694
        • Nycomed Deutschland GmbH
      • Fehmarn, Germany, 23769
        • Nycomed Deutschland GmbH
      • Frankfurt, Germany, 60311
        • Nycomed Deutschland GmbH
      • Frankfurt, Germany, 60313
        • Nycomed Deutschland GmbH
      • Frankfurt, Germany, 60590
        • Nycomed Deutschland GmbH
      • Freiburg, Germany, 79108
        • Nycomed Deutschland GmbH
      • Friedberg, Germany, 86316
        • Nycomed Deutschland GmbH
      • Geesthacht, Germany, 21502
        • Nycomed Deutschland GmbH
      • Großheirath-Rossach, Germany, 96269
        • Nycomed Deutschland GmbH
      • Göppingen, Germany, 73033
        • Nycomed Deutschland GmbH
      • Görlitz, Germany, 02826
        • Nycomed Deutschland GmbH
      • Gütersloh, Germany, 33330
        • Nycomed Deutschland GmbH
      • Hachenburg, Germany, 57627
        • Nycomed Deutschland GmbH
      • Hainburg, Germany, 63512
        • Nycomed Deutschland GmbH
      • Halle, Germany, 06110
        • Nycomed Deutschland GmbH
      • Halle, Germany, 06120
        • Nycomed Deutschland GmbH
      • Hamburg, Germany, 20095
        • Nycomed Deutschland GmbH
      • Hamburg, Germany, 22765
        • Nycomed Deutschland GmbH
      • Hameln, Germany, 31785
        • Nycomed Deutschland GmbH
      • Hannover, Germany, 30161
        • Nycomed Deutschland GmbH
      • Hannover, Germany, 30167
        • Nycomed Deutschland GmbH
      • Hannover, Germany, 30625
        • Nycomed Deutschland GmbH
      • Heidelberg, Germany, 69115
        • Nycomed Deutschland GmbH
      • Hellenthal, Germany, 53940
        • Nycomed Deutschland GmbH
      • Herne, Germany, 44625
        • Nycomed Deutschland GmbH
      • Herzlake, Germany, 49770
        • Nycomed Deutschland GmbH
      • Hohberg, Germany, 77749
        • Nycomed Deutschland GmbH
      • Hohberg-Hofweiler, Germany, 77749
        • Nycomed Deutschland GmbH
      • Holzminden, Germany, 37603
        • Nycomed Deutschland GmbH
      • Husum, Germany, 25813
        • Nycomed Deutschland GmbH
      • Iserlohn, Germany, 58638
        • Nycomed Deutschland GmbH
      • Itzehoe, Germany, 25524
        • Nycomed Deutschland GmbH
      • Jerichow, Germany, 39319
        • Nycomed Deutschland GmbH
      • Kaiserslautern, Germany, 67655
        • Nycomed Deutschland GmbH
      • Karlsbad, Germany, 76307
        • Nycomed Deutschland GmbH
      • Katzhütte, Germany, 98746
        • Nycomed Deutschland GmbH
      • Kevelaar, Germany, 47625
        • Nycomed Deutschland GmbH
      • Kiel, Germany, 24105
        • Nycomed Deutschland GmbH
      • Kiel, Germany, 24106
        • Nycomed Deutschland GmbH
      • Kiel, Germany, 24149
        • Nycomed Deutschland GmbH
      • Kirchberg, Germany, 08107
        • Nycomed Deutschland GmbH
      • Koblenz, Germany, 56068
        • Nycomed Deutschland GmbH
      • Koblenz, Germany, 56072
        • Nycomed Deutschland GmbH
      • Krefeld, Germany, 47798
        • Nycomed Deutschland GmbH
      • Krefeld, Germany, 47799
        • Nycomed Deutschland GmbH
      • Krefeld, Germany, 47803
        • Nycomed Deutschland GmbH
      • Köln, Germany, 50733
        • Nycomed Deutschland GmbH
      • Köln, Germany, 50935
        • Nycomed Deutschland GmbH
      • Köln, Germany, 50937
        • Nycomed Deutschland GmbH
      • Köln, Germany, 50996
        • Nycomed Deutschland GmbH
      • Köln, Germany, 50997
        • Nycomed Deutschland GmbH
      • Köln, Germany, 51065
        • Nycomed Deutschland GmbH
      • Köln, Germany, 51103
        • Nycomed Deutschland GmbH
      • Köthen, Germany, 06366
        • Nycomed Deutschland GmbH
      • Laatzen, Germany, 30880
        • Nycomed Deutschland GmbH
      • Lage/Lippe, Germany, 32791
        • Nycomed Deutschland GmbH
      • Landshut, Germany, 84036
        • Nycomed Deutschland GmbH
      • Leipzig, Germany, 04159
        • Nycomed Deutschland GmbH
      • Leverkusen, Germany, 51381
        • Nycomed Deutschland GmbH
      • Ludwigshafen, Germany, 67071
        • Nycomed Deutschland GmbH
      • Magdeburg, Germany, 39110
        • Nycomed Deutschland GmbH
      • Magdeburg, Germany, 39112
        • Nycomed Deutschland GmbH
      • Magdeburg, Germany, 39116
        • Nycomed Deutschland GmbH
      • Mainz, Germany, 55116
        • Nycomed Deutschland GmbH
      • Mannheim, Germany, 63167
        • Nycomed Deutschland GmbH
      • Mannheim, Germany, 68165
        • Nycomed Deutschland GmbH
      • Mayen, Germany, 56727
        • Nycomed Deutschland GmbH
      • Meinersen, Germany, 38536
        • Nycomed Deutschland GmbH
      • München, Germany, 80538
        • Nycomed Deutschland GmbH
      • Nastätten, Germany, 56355
        • Nycomed Deutschland GmbH
      • Naumburg, Germany, 06618
        • Nycomed Deutschland GmbH
      • Neubrandenburg, Germany, 17022
        • Nycomed Deutschland GmbH
      • Neubrandenburg, Germany, 17033
        • Nycomed Deutschland GmbH
      • Neuss, Germany, 41460
        • Nycomed Deutschland GmbH
      • Neustadt, Germany, 01844
        • Nycomed Deutschland GmbH
      • Neustadt, Germany, 67434
        • Nycomed Deutschland GmbH
      • Nordhorn, Germany, 48529
        • Nycomed Deutschland GmbH
      • Olpe, Germany, 57462
        • Nycomed Deutschland GmbH
      • Osloß, Germany, 38557
        • Nycomed Deutschland GmbH
      • Osnabrück, Germany, 49074
        • Nycomed Deutschland GmbH
      • Osnabrück, Germany, 49076
        • Nycomed Deutschland GmbH
      • Pforzheim, Germany, 75172
        • Nycomed Deutschland GmbH
      • Plate, Germany, 19086
        • Nycomed Deutschland GmbH
      • Plüderhausen, Germany, 73655
        • Nycomed Deutschland GmbH
      • Potsdam, Germany, 14467
        • Nycomed Deutschland GmbH
      • Potsdam-Babelsberg, Germany, 14482
        • Nycomed Deutschland GmbH
      • Pulheim-Stommeln, Germany, 50259
        • Nycomed Deutschland GmbH
      • Quedlinburg, Germany, 06484
        • Nycomed Deutschland GmbH
      • Rheine, Germany, 48431
        • Nycomed Deutschland GmbH
      • Rosenfeld, Germany, 72348
        • Nycomed Deutschland GmbH
      • Rostock, Germany, 18055
        • Nycomed Deutschland GmbH
      • Rostock, Germany, 18107
        • Nycomed Deutschland GmbH
      • Rostock, Germany, 18109
        • Nycomed Deutschland GmbH
      • Sangerhausen, Germany, 06526
        • Nycomed Deutschland GmbH
      • Schleswig, Germany, 24837
        • Nycomed Deutschland GmbH
      • Siegen, Germany, 57072
        • Nycomed Deutschland GmbH
      • Solingen, Germany, 42659
        • Nycomed Deutschland GmbH
      • St. Michaelisdonn, Germany, 25693
        • Nycomed Deutschland GmbH
      • Stendal, Germany, 39576
        • Nycomed Deutschland GmbH
      • Stuttgart, Germany, 70619
        • Nycomed Deutschland GmbH
      • Tangermünde, Germany, 39590
        • Nycomed Deutschland GmbH
      • Ulm, Germany, 89073
        • Nycomed Deutschland GmbH
      • Ulm, Germany, 89075
        • Nycomed Deutschland GmbH
      • Ulm, Germany, 89077
        • Nycomed Deutschland GmbH
      • Varel, Germany, 26316
        • Nycomed Deutschland GmbH
      • Velbert, Germany, 42551
        • Nycomed Deutschland GmbH
      • Villingen-Schwenningen, Germany, 78054
        • Nycomed Deutschland GmbH
      • Wedel, Germany, 22880
        • Nycomed Deutschland GmbH
      • Weinsberg, Germany, 74189
        • Nycomed Deutschland GmbH
      • Werdau, Germany, 08412
        • Nycomed Deutschland GmbH
      • Wesendorf, Germany, 29392
        • Nycomed Deutschland GmbH
      • Westhausen, Germany, 73463
        • Nycomed Deutschland GmbH
      • Wiesbaden, Germany, 65189
        • Nycomed Deutschland GmbH
      • Wiesbaden, Germany, 65191
        • Nycomed Deutschland GmbH
      • Wilster, Germany, 25554
        • Nycomed Deutschland GmbH
      • Zwickau, Germany, 08056
        • Nycomed Deutschland GmbH
      • Zwönitz, Germany, 08297
        • Nycomed Deutschland GmbH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Outpatients

Description

Inclusion criteria:

  • decision to start treatment with intranasal fentanyl spray
  • written informed consent

Exclusion criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
GENISIS
Drug: Instanyl (Intranasal Fentanyl)
This was an observational study. Therefore, the physician decided about dosage according to individual needs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dose of Instanyl
Time Frame: during therapy with Instanyl (planned: 28 days)
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
Time Frame: before and after therapy with Instanyl (first/last visit)
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)
Time Frame: before and after therapy with Instanyl (first/last visit)
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)
Time Frame: after therapy with Instanyl (planned: 4 weeks)
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)
Time Frame: after therapy with Instanyl (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 ...
Time Frame: before and after therapy with Instanyl (first/last visit)
Scale: 0=no, 1=low, 2=medium, 3=high
before and after therapy with Instanyl (first/last visit)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physician: Degree of Relief of Breakthrough Pain Achieved by Instanyl at Study End
Time Frame: after therapy with Instanyl (planned: 4 weeks)
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?
Time Frame: initial visit (before start of therapy with Instanyl)
initial visit (before start of therapy with Instanyl)
Patient: Description of Pain at Initial Visit
Time Frame: initial visit (before start of therapy with Instanyl)
0=no pain, 10= most intense pain imaginable
initial visit (before start of therapy with Instanyl)
Patient: How do You Feel Today?
Time Frame: before and after therapy with Instanyl (first/last visit)
Scale: 1=very bad, 2=bad, 3=mediocre, 4=good, 5=very good
before and after therapy with Instanyl (first/last visit)
Patient: To What Extent Your Present Condition is Affected by Your Pain Attacks?
Time Frame: before and after therapy with Instanyl (first/last visit)
Scale: 0=not at all, 10=completely
before and after therapy with Instanyl (first/last visit)
Patient: Modified Pain Disability Index (mPDI) - Sum - Score (Complete Questionnaires Only)
Time Frame: before and after therapy with Instanyl (first/last visit)
Scale: 0=no impairment, 70=complete impairment
before and after therapy with Instanyl (first/last visit)
Patient: Quality-of-Life-Impairment by Pain =QLIP - Sum - Score (Complete Questionnaires Only)
Time Frame: before and after therapy with Instanyl (first/last visit)
Scale: 0=complete impairment, 43=no impairment
before and after therapy with Instanyl (first/last visit)
Patient: Quality-of-Life-Impairment by Pain =QLIP - Sum - Score (Complete Questionnaires Only) Conspicuous ≤20
Time Frame: before and after therapy with Instanyl (first/last visit)

0= conspicuous ≤20

1= inconspicuous >20
before and after therapy with Instanyl (first/last visit)
Patient: Marburg Questionnaire on Habitual Health (MQHH): Sum - Score (Complete Questionnaires Only)
Time Frame: before and after therapy with Instanyl (first/last visit)
Scale: 0=worst, 5=best
before and after therapy with Instanyl (first/last visit)
Patient: Marburg Questionnaire on Habitual Health (MQHH): Sum - Score (Complete Questionnaires Only) Conspicuous <1.5
Time Frame: before and after therapy with Instanyl (first/last visit)
conspicuous score <1.5 inconspicuous score ≥1.5
before and after therapy with Instanyl (first/last visit)
Patient: Degree of Relief of Breakthrough Pain Achieved by Instanyl at Study End
Time Frame: after therapy with Instanyl (planned: 4 weeks)
0=no reduction, 1=slight, 2=medium, 3=strong, 4=very strong, 5=complete
after therapy with Instanyl (planned: 4 weeks)
Patient: Assessment of Breakthrough Pain Therapy (Initial Visit: Previous/Last Visit: Instanyl)
Time Frame: before and after therapy with Instanyl (first/last visit)
Scale: 1=very good, 2=good, 3=satisfactory, 4=poor, 5=very poor, 6=insufficient
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)
Time Frame: after therapy with Instanyl (planned: 4 weeks)
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)
Patient: To What Extent Changes Have Occurred Induced by the Treatment of Breakthrough Pain With Instanyl With Respect to ...(at Last Visit)
Time Frame: after therapy with Instanyl (at last visit)
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)
Caregiver: Degree of Relief of Breakthrough Pain Achieved by Instany at Study End
Time Frame: after therapy with Instanyl (planned: 4 weeks)
0=no reduction, 1=slight, 2=medium, 3=strong, 4=very strong, 5=complete
after therapy with Instanyl (planned: 4 weeks)
Caregiver: Assessment of Breakthrough Pain Therapy by Instanyl (Last Visit)
Time Frame: after therapy with Instanyl (first/last visit)
Scale: 1=very good, 2=good, 3=satisfactory, 4=poor, 5=very poor, 6=insufficient
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)
Time Frame: after therapy with Instanyl (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)
Caregiver: To What Extent the Treatment Needs of Your Patient Has Changed by the Use of Instanyl Regarding ...
Time Frame: after therapy with Instanyl (last visit)
Scale: -3= very much less, -2= much less, -1= less, 0=comparable, 1= more, 2= much more, 3= very much more
after therapy with Instanyl (last visit)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Takeda

Investigators

  • Study Director: Dr. Thomas D. Bethke, PhD; MD, Nycomed Deutschland GmbH, 78467 Konstanz, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

October 5, 2009

First Submitted That Met QC Criteria

October 13, 2009

First Posted (Estimate)

October 14, 2009

Study Record Updates

Last Update Posted (Estimate)

September 27, 2012

Last Update Submitted That Met QC Criteria

August 27, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FT-1301-401-DE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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