Cancer Clinical Trial
— GENISISOfficial title:
A Prospective Non-interventional/Observational Patient Cohort Study on the Efficacy of Intranasal Fentanyl Spray for the Treatment of Breakthrough Pain in Cancer Patients.
| Verified date | August 2012 |
| Source | Takeda |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Germany: Federal Institute for Drugs and Medical Devices |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 131 |
| Est. completion date | November 2010 |
| Est. primary completion date | September 2010 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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) |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Germany | Nycomed Deutschland GmbH | Aachen | |
| Germany | Nycomed Deutschland GmbH | Adendorf | |
| Germany | Nycomed Deutschland GmbH | Aichach | |
| Germany | Nycomed Deutschland GmbH | Albstadt | |
| Germany | Nycomed Deutschland GmbH | Albstadt-Ebingen | |
| Germany | Nycomed Deutschland GmbH | Altenkirchen | |
| Germany | Nycomed Deutschland GmbH | Aschaffenburg | |
| Germany | Nycomed Deutschland GmbH | Aschersleben | |
| Germany | Nycomed Deutschland GmbH | Augsburg | |
| Germany | Nycomed Deutschland GmbH | Augsburg | |
| Germany | Nycomed Deutschland GmbH | Backnang | |
| Germany | Nycomed Deutschland GmbH | Bad Bevensen | |
| Germany | Nycomed Deutschland GmbH | Bad Dürkheim | |
| Germany | Nycomed Deutschland GmbH | Bad Liebenstein | |
| Germany | Nycomed Deutschland GmbH | Bad Pyrmont | |
| Germany | Nycomed Deutschland GmbH | Bad Schwalbach | |
| Germany | Nycomed Deutschland GmbH | Badel | |
| Germany | Nycomed Deutschland GmbH | Bademühlen | |
| Germany | Nycomed Deutschland GmbH | Bautzen | |
| Germany | Nycomed Deutschland GmbH | Berlin | |
| Germany | Nycomed Deutschland GmbH | Berlin | |
| Germany | Nycomed Deutschland GmbH | Berlin | |
| Germany | Nycomed Deutschland GmbH | Berlin | |
| Germany | Nycomed Deutschland GmbH | Berlin | |
| Germany | Nycomed Deutschland GmbH | Berlin | |
| Germany | Nycomed Deutschland GmbH | Berlin | |
| Germany | Nycomed Deutschland GmbH | Berlin | |
| Germany | Nycomed Deutschland GmbH | Berlin | |
| Germany | Nycomed Deutschland GmbH | Böblingen | |
| Germany | Nycomed Deutschland GmbH | Bochum | |
| Germany | Nycomed Deutschland GmbH | Bonn | |
| Germany | Nycomed Deutschland GmbH | Brandenburg/Havel | |
| Germany | Nycomed Deutschland GmbH | Braunschweig | |
| Germany | Nycomed Deutschland GmbH | Bremen | |
| Germany | Nycomed Deutschland GmbH | Brühl | |
| Germany | Nycomed Deutschland GmbH | Burg | |
| Germany | Nycomed Deutschland GmbH | Burg/Fehmarn | |
| Germany | Nycomed Deutschland GmbH | Burscheid | |
| Germany | Nycomed Deutschland GmbH | Butzbach | |
| Germany | Nycomed Deutschland GmbH | Coburg | |
| Germany | Nycomed Deutschland GmbH | Cochem | |
| Germany | Nycomed Deutschland GmbH | Cottbus | |
| Germany | Nycomed Deutschland GmbH | Cuxhaven | |
| Germany | Nycomed Deutschland GmbH | Cuxhaven | |
| Germany | Nycomed Deutschland GmbH | Dessau-Roßlau | |
| Germany | Nycomed Deutschland GmbH | Dresden | |
| Germany | Nycomed Deutschland GmbH | Dresden | |
| Germany | Nycomed Deutschland GmbH | Dresden | |
| Germany | Nycomed Deutschland GmbH | Duisburg | |
| Germany | Nycomed Deutschland GmbH | Düsseldorf | |
| Germany | Nycomed Deutschland GmbH | Essen | |
| Germany | Nycomed Deutschland GmbH | Etzenricht | |
| Germany | Nycomed Deutschland GmbH | Fehmarn | |
| Germany | Nycomed Deutschland GmbH | Frankfurt | |
| Germany | Nycomed Deutschland GmbH | Frankfurt | |
| Germany | Nycomed Deutschland GmbH | Frankfurt | |
| Germany | Nycomed Deutschland GmbH | Freiburg | |
| Germany | Nycomed Deutschland GmbH | Friedberg | |
| Germany | Nycomed Deutschland GmbH | Geesthacht | |
| Germany | Nycomed Deutschland GmbH | Göppingen | |
| Germany | Nycomed Deutschland GmbH | Görlitz | |
| Germany | Nycomed Deutschland GmbH | Großheirath-Rossach | |
| Germany | Nycomed Deutschland GmbH | Gütersloh | |
| Germany | Nycomed Deutschland GmbH | Hachenburg | |
| Germany | Nycomed Deutschland GmbH | Hainburg | |
| Germany | Nycomed Deutschland GmbH | Halle | |
| Germany | Nycomed Deutschland GmbH | Halle | |
| Germany | Nycomed Deutschland GmbH | Hamburg | |
| Germany | Nycomed Deutschland GmbH | Hamburg | |
| Germany | Nycomed Deutschland GmbH | Hameln | |
| Germany | Nycomed Deutschland GmbH | Hannover | |
| Germany | Nycomed Deutschland GmbH | Hannover | |
| Germany | Nycomed Deutschland GmbH | Hannover | |
| Germany | Nycomed Deutschland GmbH | Heidelberg | |
| Germany | Nycomed Deutschland GmbH | Hellenthal | |
| Germany | Nycomed Deutschland GmbH | Herne | |
| Germany | Nycomed Deutschland GmbH | Herzlake | |
| Germany | Nycomed Deutschland GmbH | Hohberg | |
| Germany | Nycomed Deutschland GmbH | Hohberg-Hofweiler | |
| Germany | Nycomed Deutschland GmbH | Holzminden | |
| Germany | Nycomed Deutschland GmbH | Husum | |
| Germany | Nycomed Deutschland GmbH | Iserlohn | |
| Germany | Nycomed Deutschland GmbH | Itzehoe | |
| Germany | Nycomed Deutschland GmbH | Jerichow | |
| Germany | Nycomed Deutschland GmbH | Kaiserslautern | |
| Germany | Nycomed Deutschland GmbH | Karlsbad | |
| Germany | Nycomed Deutschland GmbH | Katzhütte | |
| Germany | Nycomed Deutschland GmbH | Kevelaar | |
| Germany | Nycomed Deutschland GmbH | Kiel | |
| Germany | Nycomed Deutschland GmbH | Kiel | |
| Germany | Nycomed Deutschland GmbH | Kiel | |
| Germany | Nycomed Deutschland GmbH | Kirchberg | |
| Germany | Nycomed Deutschland GmbH | Koblenz | |
| Germany | Nycomed Deutschland GmbH | Koblenz | |
| Germany | Nycomed Deutschland GmbH | Köln | |
| Germany | Nycomed Deutschland GmbH | Köln | |
| Germany | Nycomed Deutschland GmbH | Köln | |
| Germany | Nycomed Deutschland GmbH | Köln | |
| Germany | Nycomed Deutschland GmbH | Köln | |
| Germany | Nycomed Deutschland GmbH | Köln | |
| Germany | Nycomed Deutschland GmbH | Köln | |
| Germany | Nycomed Deutschland GmbH | Köthen | |
| Germany | Nycomed Deutschland GmbH | Krefeld | |
| Germany | Nycomed Deutschland GmbH | Krefeld | |
| Germany | Nycomed Deutschland GmbH | Krefeld | |
| Germany | Nycomed Deutschland GmbH | Laatzen | |
| Germany | Nycomed Deutschland GmbH | Lage/Lippe | |
| Germany | Nycomed Deutschland GmbH | Landshut | |
| Germany | Nycomed Deutschland GmbH | Leipzig | |
| Germany | Nycomed Deutschland GmbH | Leverkusen | |
| Germany | Nycomed Deutschland GmbH | Ludwigshafen | |
| Germany | Nycomed Deutschland GmbH | Magdeburg | |
| Germany | Nycomed Deutschland GmbH | Magdeburg | |
| Germany | Nycomed Deutschland GmbH | Magdeburg | |
| Germany | Nycomed Deutschland GmbH | Mainz | |
| Germany | Nycomed Deutschland GmbH | Mannheim | |
| Germany | Nycomed Deutschland GmbH | Mannheim | |
| Germany | Nycomed Deutschland GmbH | Mayen | |
| Germany | Nycomed Deutschland GmbH | Meinersen | |
| Germany | Nycomed Deutschland GmbH | München | |
| Germany | Nycomed Deutschland GmbH | Nastätten | |
| Germany | Nycomed Deutschland GmbH | Naumburg | |
| Germany | Nycomed Deutschland GmbH | Neubrandenburg | |
| Germany | Nycomed Deutschland GmbH | Neubrandenburg | |
| Germany | Nycomed Deutschland GmbH | Neuss | |
| Germany | Nycomed Deutschland GmbH | Neustadt | |
| Germany | Nycomed Deutschland GmbH | Neustadt | |
| Germany | Nycomed Deutschland GmbH | Nordhorn | |
| Germany | Nycomed Deutschland GmbH | Olpe | |
| Germany | Nycomed Deutschland GmbH | Osloß | |
| Germany | Nycomed Deutschland GmbH | Osnabrück | |
| Germany | Nycomed Deutschland GmbH | Osnabrück | |
| Germany | Nycomed Deutschland GmbH | Pforzheim | |
| Germany | Nycomed Deutschland GmbH | Plate | |
| Germany | Nycomed Deutschland GmbH | Plüderhausen | |
| Germany | Nycomed Deutschland GmbH | Potsdam | |
| Germany | Nycomed Deutschland GmbH | Potsdam-Babelsberg | |
| Germany | Nycomed Deutschland GmbH | Pulheim-Stommeln | |
| Germany | Nycomed Deutschland GmbH | Quedlinburg | |
| Germany | Nycomed Deutschland GmbH | Rheine | |
| Germany | Nycomed Deutschland GmbH | Rosenfeld | |
| Germany | Nycomed Deutschland GmbH | Rostock | |
| Germany | Nycomed Deutschland GmbH | Rostock | |
| Germany | Nycomed Deutschland GmbH | Rostock | |
| Germany | Nycomed Deutschland GmbH | Sangerhausen | |
| Germany | Nycomed Deutschland GmbH | Schleswig | |
| Germany | Nycomed Deutschland GmbH | Siegen | |
| Germany | Nycomed Deutschland GmbH | Solingen | |
| Germany | Nycomed Deutschland GmbH | St. Michaelisdonn | |
| Germany | Nycomed Deutschland GmbH | Stendal | |
| Germany | Nycomed Deutschland GmbH | Stuttgart | |
| Germany | Nycomed Deutschland GmbH | Tangermünde | |
| Germany | Nycomed Deutschland GmbH | Ulm | |
| Germany | Nycomed Deutschland GmbH | Ulm | |
| Germany | Nycomed Deutschland GmbH | Ulm | |
| Germany | Nycomed Deutschland GmbH | Varel | |
| Germany | Nycomed Deutschland GmbH | Velbert | |
| Germany | Nycomed Deutschland GmbH | Villingen-Schwenningen | |
| Germany | Nycomed Deutschland GmbH | Wedel | |
| Germany | Nycomed Deutschland GmbH | Weinsberg | |
| Germany | Nycomed Deutschland GmbH | Werdau | |
| Germany | Nycomed Deutschland GmbH | Wesendorf | |
| Germany | Nycomed Deutschland GmbH | Westhausen | |
| Germany | Nycomed Deutschland GmbH | Wiesbaden | |
| Germany | Nycomed Deutschland GmbH | Wiesbaden | |
| Germany | Nycomed Deutschland GmbH | Wilster | |
| Germany | Nycomed Deutschland GmbH | Zwickau | |
| Germany | Nycomed Deutschland GmbH | Zwönitz |
| Lead Sponsor | Collaborator |
|---|---|
| Takeda |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Dose of Instanyl | Initially prescribed dose/ most efficient single dose of Instanyl at study end | during therapy with Instanyl (planned: 28 days) | No |
| 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 | before and after therapy with Instanyl (first/last visit) | No |
| 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 | before and after therapy with Instanyl (first/last visit) | No |
| 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 | after therapy with Instanyl (planned: 4 weeks) | No |
| 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 | after therapy with Instanyl (at last visit) | No |
| Primary | 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) | No |
| 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 | after therapy with Instanyl (planned: 4 weeks) | No |
| Secondary | Patient: How Many Episodes of Pain You Experience on Average? | initial visit (before start of therapy with Instanyl) | No | |
| Secondary | Patient: Description of Pain at Initial Visit | 0=no pain, 10= most intense pain imaginable | initial visit (before start of therapy with Instanyl) | No |
| Secondary | Patient: How do You Feel Today? | Scale: 1=very bad, 2=bad, 3=mediocre, 4=good, 5=very good | before and after therapy with Instanyl (first/last visit) | No |
| Secondary | Patient: To What Extent Your Present Condition is Affected by Your Pain Attacks? | Scale: 0=not at all, 10=completely | before and after therapy with Instanyl (first/last visit) | No |
| Secondary | Patient: Modified Pain Disability Index (mPDI) - Sum - Score (Complete Questionnaires Only) | Scale: 0=no impairment, 70=complete impairment | before and after therapy with Instanyl (first/last visit) | No |
| Secondary | Patient: Quality-of-Life-Impairment by Pain =QLIP - Sum - Score (Complete Questionnaires Only) | Scale: 0=complete impairment, 43=no impairment | before and after therapy with Instanyl (first/last visit) | No |
| Secondary | Patient: Quality-of-Life-Impairment by Pain =QLIP - Sum - Score (Complete Questionnaires Only) Conspicuous =20 | 0= conspicuous =20 1= inconspicuous >20 |
before and after therapy with Instanyl (first/last visit) | No |
| Secondary | Patient: Marburg Questionnaire on Habitual Health (MQHH): Sum - Score (Complete Questionnaires Only) | Scale: 0=worst, 5=best | before and after therapy with Instanyl (first/last visit) | No |
| Secondary | Patient: Marburg Questionnaire on Habitual Health (MQHH): Sum - Score (Complete Questionnaires Only) Conspicuous <1.5 | conspicuous score <1.5 inconspicuous score =1.5 | before and after therapy with Instanyl (first/last visit) | No |
| 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 | after therapy with Instanyl (planned: 4 weeks) | No |
| 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 | before and after therapy with Instanyl (first/last visit) | No |
| 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 | after therapy with Instanyl (planned: 4 weeks) | No |
| 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 | after therapy with Instanyl (at last visit) | No |
| 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 | after therapy with Instanyl (planned: 4 weeks) | No |
| 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 | after therapy with Instanyl (first/last visit) | No |
| 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 | after therapy with Instanyl (at last visit) | No |
| 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 | after therapy with Instanyl (last visit) | No |
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