Clinical trial NCT00994760: Efficacy and Tolerability of Intranasal Fentanyl Spray for the Treatment of Breakthrough Pain in Cancer Patients Older Than 18 Years
Official 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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breakthrough Pain
Cancer
Keywords: intranasal fentanyl spray
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2009-10-14
Enrollment: 131
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Outpatients

Brief summary: The aim of the study was to evaluate the safety and efficacy of intranasal fentanyl spray in cancer patients over four weeks, especially during cancer-related breakthrough pain (BTP) attacks. The fentanyl spray was applied into the nose by a metered-spray device. The study was to provide further data on pharmacoeconomic efficiency of intranasal fentanyl spray.


Eligibility criteria: 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)

Primary outcomes:
measure: Dose of Instanyl
timeFrame: during therapy with Instanyl (planned: 28 days)
measure: Physician: Degree of Maximum Pain Intensity During the Last Days/ Since the Last Examination
timeFrame: before and after therapy with Instanyl (first/last visit)
measure: Physician: Assessment of Breakthrough Pain Therapy (Initial Visit: Previous/Last Visit: Instanyl)
timeFrame: before and after therapy with Instanyl (first/last visit)
measure: Physician: To What Extent Did Your Expectations in Instanyl Have Met? (Last Visit)
timeFrame: after therapy with Instanyl (planned: 4 weeks)
measure: Physician: To What Extent Changes Have Occurred Induced by the Treatment of Breakthrough Pain With Instanyl With Respect to ... (at Last Visit)
timeFrame: after therapy with Instanyl (at last visit)
measure: Physician: What is the Current Treatment Needs of Your Patient Regarding ...
timeFrame: before and after therapy with Instanyl (first/last visit)
Secondary outcomes:
measure: Physician: Degree of Relief of Breakthrough Pain Achieved by Instanyl at Study End
timeFrame: after therapy with Instanyl (planned: 4 weeks)
measure: Patient: How Many Episodes of Pain You Experience on Average?
timeFrame: initial visit (before start of therapy with Instanyl)
measure: Patient: Description of Pain at Initial Visit
timeFrame: initial visit (before start of therapy with Instanyl)
measure: Patient: How do You Feel Today?
timeFrame: before and after therapy with Instanyl (first/last visit)
measure: Patient: To What Extent Your Present Condition is Affected by Your Pain Attacks?
timeFrame: before and after therapy with Instanyl (first/last visit)
measure: Patient: Modified Pain Disability Index (mPDI) - Sum - Score (Complete Questionnaires Only)
timeFrame: before and after therapy with Instanyl (first/last visit)
measure: Patient: Quality-of-Life-Impairment by Pain =QLIP - Sum - Score (Complete Questionnaires Only)
timeFrame: before and after therapy with Instanyl (first/last visit)
measure: Patient: Quality-of-Life-Impairment by Pain =QLIP - Sum - Score (Complete Questionnaires Only) Conspicuous ≤20
timeFrame: before and after therapy with Instanyl (first/last visit)
measure: Patient: Marburg Questionnaire on Habitual Health (MQHH): Sum - Score (Complete Questionnaires Only)
timeFrame: before and after therapy with Instanyl (first/last visit)
measure: Patient: Marburg Questionnaire on Habitual Health (MQHH): Sum - Score (Complete Questionnaires Only) Conspicuous <1.5
timeFrame: before and after therapy with Instanyl (first/last visit)
measure: Patient: Degree of Relief of Breakthrough Pain Achieved by Instanyl at Study End
timeFrame: after therapy with Instanyl (planned: 4 weeks)
measure: Patient: Assessment of Breakthrough Pain Therapy (Initial Visit: Previous/Last Visit: Instanyl)
timeFrame: before and after therapy with Instanyl (first/last visit)
measure: Patient: To What Extent Did Your Expectations in Instanyl Have Met With Respect to ... (Last Visit)
timeFrame: after therapy with Instanyl (planned: 4 weeks)
measure: Patient: To What Extent Changes Have Occurred Induced by the Treatment of Breakthrough Pain With Instanyl With Respect to ...(at Last Visit)
timeFrame: after therapy with Instanyl (at last visit)
measure: Caregiver: Degree of Relief of Breakthrough Pain Achieved by Instany at Study End
timeFrame: after therapy with Instanyl (planned: 4 weeks)
measure: Caregiver: Assessment of Breakthrough Pain Therapy by Instanyl (Last Visit)
timeFrame: after therapy with Instanyl (first/last visit)
measure: Caregiver: To What Extent Changes Have Occurred Induced by the Treatment of Breakthrough Pain With Instanyl With Respect to ... (at Last Visit)
timeFrame: after therapy with Instanyl (at last visit)
measure: Caregiver: To What Extent the Treatment Needs of Your Patient Has Changed by the Use of Instanyl Regarding ...
timeFrame: after therapy with Instanyl (last visit)
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Nycomed Deutschland GmbH
city: Adendorf
country: Germany
facility: Nycomed Deutschland GmbH
city: Aichach
country: Germany
facility: Nycomed Deutschland GmbH
city: Albstadt-Ebingen
country: Germany
facility: Nycomed Deutschland GmbH
city: Albstadt
country: Germany
facility: Nycomed Deutschland GmbH
city: Altenkirchen
country: Germany
facility: Nycomed Deutschland GmbH
city: Aschaffenburg
country: Germany
facility: Nycomed Deutschland GmbH
city: Aschersleben
country: Germany
facility: Nycomed Deutschland GmbH
city: Augsburg
country: Germany
facility: Nycomed Deutschland GmbH
city: Augsburg
country: Germany
facility: Nycomed Deutschland GmbH
city: Backnang
country: Germany
facility: Nycomed Deutschland GmbH
city: Bad Bevensen
country: Germany
facility: Nycomed Deutschland GmbH
city: Bad Dürkheim
country: Germany
facility: Nycomed Deutschland GmbH
city: Bad Liebenstein
country: Germany
facility: Nycomed Deutschland GmbH
city: Bad Pyrmont
country: Germany
facility: Nycomed Deutschland GmbH
city: Bad Schwalbach
country: Germany
facility: Nycomed Deutschland GmbH
city: Badel
country: Germany
facility: Nycomed Deutschland GmbH
city: Bademühlen
country: Germany
facility: Nycomed Deutschland GmbH
city: Bautzen
country: Germany
facility: Nycomed Deutschland GmbH
city: Berlin
country: Germany
facility: Nycomed Deutschland GmbH
city: Berlin
country: Germany
facility: Nycomed Deutschland GmbH
city: Berlin
country: Germany
facility: Nycomed Deutschland GmbH
city: Berlin
country: Germany
facility: Nycomed Deutschland GmbH
city: Berlin
country: Germany
facility: Nycomed Deutschland GmbH
city: Berlin
country: Germany
facility: Nycomed Deutschland GmbH
city: Berlin
country: Germany
facility: Nycomed Deutschland GmbH
city: Berlin
country: Germany
facility: Nycomed Deutschland GmbH
city: Berlin
country: Germany
facility: Nycomed Deutschland GmbH
city: Bochum
country: Germany
facility: Nycomed Deutschland GmbH
city: Bonn
country: Germany
facility: Nycomed Deutschland GmbH
city: Brandenburg/Havel
country: Germany
facility: Nycomed Deutschland GmbH
city: Braunschweig
country: Germany
facility: Nycomed Deutschland GmbH
city: Bremen
country: Germany
facility: Nycomed Deutschland GmbH
city: Brühl
country: Germany
facility: Nycomed Deutschland GmbH
city: Burg/Fehmarn
country: Germany
facility: Nycomed Deutschland GmbH
city: Burg
country: Germany
facility: Nycomed Deutschland GmbH
city: Burscheid
country: Germany
facility: Nycomed Deutschland GmbH
city: Butzbach
country: Germany
facility: Nycomed Deutschland GmbH
city: Böblingen
country: Germany
facility: Nycomed Deutschland GmbH
city: Coburg
country: Germany
facility: Nycomed Deutschland GmbH
city: Cochem
country: Germany
facility: Nycomed Deutschland GmbH
city: Cottbus
country: Germany
facility: Nycomed Deutschland GmbH
city: Cuxhaven
country: Germany
facility: Nycomed Deutschland GmbH
city: Cuxhaven
country: Germany
facility: Nycomed Deutschland GmbH
city: Dessau-Roßlau
country: Germany
facility: Nycomed Deutschland GmbH
city: Dresden
country: Germany
facility: Nycomed Deutschland GmbH
city: Dresden
country: Germany
facility: Nycomed Deutschland GmbH
city: Dresden
country: Germany
facility: Nycomed Deutschland GmbH
city: Duisburg
country: Germany
facility: Nycomed Deutschland GmbH
city: Düsseldorf
country: Germany
facility: Nycomed Deutschland GmbH
city: Essen
country: Germany
facility: Nycomed Deutschland GmbH
city: Etzenricht
country: Germany
facility: Nycomed Deutschland GmbH
city: Fehmarn
country: Germany
facility: Nycomed Deutschland GmbH
city: Frankfurt
country: Germany
facility: Nycomed Deutschland GmbH
city: Frankfurt
country: Germany
facility: Nycomed Deutschland GmbH
city: Frankfurt
country: Germany
facility: Nycomed Deutschland GmbH
city: Freiburg
country: Germany
facility: Nycomed Deutschland GmbH
city: Friedberg
country: Germany
facility: Nycomed Deutschland GmbH
city: Geesthacht
country: Germany
facility: Nycomed Deutschland GmbH
city: Großheirath-Rossach
country: Germany
facility: Nycomed Deutschland GmbH
city: Göppingen
country: Germany
facility: Nycomed Deutschland GmbH
city: Görlitz
country: Germany
facility: Nycomed Deutschland GmbH
city: Gütersloh
country: Germany
facility: Nycomed Deutschland GmbH
city: Hachenburg
country: Germany
facility: Nycomed Deutschland GmbH
city: Hainburg
country: Germany
facility: Nycomed Deutschland GmbH
city: Halle
country: Germany
facility: Nycomed Deutschland GmbH
city: Halle
country: Germany
facility: Nycomed Deutschland GmbH
city: Hamburg
country: Germany
facility: Nycomed Deutschland GmbH
city: Hamburg
country: Germany
facility: Nycomed Deutschland GmbH
city: Hameln
country: Germany
facility: Nycomed Deutschland GmbH
city: Hannover
country: Germany
facility: Nycomed Deutschland GmbH
city: Hannover
country: Germany
facility: Nycomed Deutschland GmbH
city: Hannover
country: Germany
facility: Nycomed Deutschland GmbH
city: Heidelberg
country: Germany
facility: Nycomed Deutschland GmbH
city: Hellenthal
country: Germany
facility: Nycomed Deutschland GmbH
city: Herne
country: Germany
facility: Nycomed Deutschland GmbH
city: Herzlake
country: Germany
facility: Nycomed Deutschland GmbH
city: Hohberg-Hofweiler
country: Germany
facility: Nycomed Deutschland GmbH
city: Hohberg
country: Germany
facility: Nycomed Deutschland GmbH
city: Holzminden
country: Germany
facility: Nycomed Deutschland GmbH
city: Husum
country: Germany
facility: Nycomed Deutschland GmbH
city: Iserlohn
country: Germany
facility: Nycomed Deutschland GmbH
city: Itzehoe
country: Germany
facility: Nycomed Deutschland GmbH
city: Jerichow
country: Germany
facility: Nycomed Deutschland GmbH
city: Kaiserslautern
country: Germany
facility: Nycomed Deutschland GmbH
city: Karlsbad
country: Germany
facility: Nycomed Deutschland GmbH
city: Katzhütte
country: Germany
facility: Nycomed Deutschland GmbH
city: Kevelaar
country: Germany
facility: Nycomed Deutschland GmbH
city: Kiel
country: Germany
facility: Nycomed Deutschland GmbH
city: Kiel
country: Germany
facility: Nycomed Deutschland GmbH
city: Kiel
country: Germany
facility: Nycomed Deutschland GmbH
city: Kirchberg
country: Germany
facility: Nycomed Deutschland GmbH
city: Koblenz
country: Germany
facility: Nycomed Deutschland GmbH
city: Koblenz
country: Germany
facility: Nycomed Deutschland GmbH
city: Krefeld
country: Germany
facility: Nycomed Deutschland GmbH
city: Krefeld
country: Germany
facility: Nycomed Deutschland GmbH
city: Krefeld
country: Germany
facility: Nycomed Deutschland GmbH
city: Köln
country: Germany
facility: Nycomed Deutschland GmbH
city: Köln
country: Germany
facility: Nycomed Deutschland GmbH
city: Köln
country: Germany
facility: Nycomed Deutschland GmbH
city: Köln
country: Germany
facility: Nycomed Deutschland GmbH
city: Köln
country: Germany
facility: Nycomed Deutschland GmbH
city: Köln
country: Germany
facility: Nycomed Deutschland GmbH
city: Köln
country: Germany
facility: Nycomed Deutschland GmbH
city: Köthen
country: Germany
facility: Nycomed Deutschland GmbH
city: Laatzen
country: Germany
facility: Nycomed Deutschland GmbH
city: Lage/Lippe
country: Germany
facility: Nycomed Deutschland GmbH
city: Landshut
country: Germany
facility: Nycomed Deutschland GmbH
city: Leipzig
country: Germany
facility: Nycomed Deutschland GmbH
city: Leverkusen
country: Germany
facility: Nycomed Deutschland GmbH
city: Ludwigshafen
country: Germany
facility: Nycomed Deutschland GmbH
city: Magdeburg
country: Germany
facility: Nycomed Deutschland GmbH
city: Magdeburg
country: Germany
facility: Nycomed Deutschland GmbH
city: Magdeburg
country: Germany
facility: Nycomed Deutschland GmbH
city: Mainz
country: Germany
facility: Nycomed Deutschland GmbH
city: Mannheim
country: Germany
facility: Nycomed Deutschland GmbH
city: Mannheim
country: Germany
facility: Nycomed Deutschland GmbH
city: Mayen
country: Germany
facility: Nycomed Deutschland GmbH
city: Meinersen
country: Germany
facility: Nycomed Deutschland GmbH
city: München
country: Germany
facility: Nycomed Deutschland GmbH
city: Nastätten
country: Germany
facility: Nycomed Deutschland GmbH
city: Naumburg
country: Germany
facility: Nycomed Deutschland GmbH
city: Neubrandenburg
country: Germany
facility: Nycomed Deutschland GmbH
city: Neubrandenburg
country: Germany
facility: Nycomed Deutschland GmbH
city: Neuss
country: Germany
facility: Nycomed Deutschland GmbH
city: Neustadt
country: Germany
facility: Nycomed Deutschland GmbH
city: Neustadt
country: Germany
facility: Nycomed Deutschland GmbH
city: Nordhorn
country: Germany
facility: Nycomed Deutschland GmbH
city: Olpe
country: Germany
facility: Nycomed Deutschland GmbH
city: Osloß
country: Germany
facility: Nycomed Deutschland GmbH
city: Osnabrück
country: Germany
facility: Nycomed Deutschland GmbH
city: Osnabrück
country: Germany
facility: Nycomed Deutschland GmbH
city: Pforzheim
country: Germany
facility: Nycomed Deutschland GmbH
city: Plate
country: Germany
facility: Nycomed Deutschland GmbH
city: Plüderhausen
country: Germany
facility: Nycomed Deutschland GmbH
city: Potsdam-Babelsberg
country: Germany
facility: Nycomed Deutschland GmbH
city: Potsdam
country: Germany
facility: Nycomed Deutschland GmbH
city: Pulheim-Stommeln
country: Germany
facility: Nycomed Deutschland GmbH
city: Quedlinburg
country: Germany
facility: Nycomed Deutschland GmbH
city: Rheine
country: Germany
facility: Nycomed Deutschland GmbH
city: Rosenfeld
country: Germany
facility: Nycomed Deutschland GmbH
city: Rostock
country: Germany
facility: Nycomed Deutschland GmbH
city: Rostock
country: Germany
facility: Nycomed Deutschland GmbH
city: Rostock
country: Germany
facility: Nycomed Deutschland GmbH
city: Sangerhausen
country: Germany
facility: Nycomed Deutschland GmbH
city: Schleswig
country: Germany
facility: Nycomed Deutschland GmbH
city: Siegen
country: Germany
facility: Nycomed Deutschland GmbH
city: Solingen
country: Germany
facility: Nycomed Deutschland GmbH
city: St. Michaelisdonn
country: Germany
facility: Nycomed Deutschland GmbH
city: Stendal
country: Germany
facility: Nycomed Deutschland GmbH
city: Stuttgart
country: Germany
facility: Nycomed Deutschland GmbH
city: Tangermünde
country: Germany
facility: Nycomed Deutschland GmbH
city: Ulm
country: Germany
facility: Nycomed Deutschland GmbH
city: Ulm
country: Germany
facility: Nycomed Deutschland GmbH
city: Ulm
country: Germany
facility: Nycomed Deutschland GmbH
city: Varel
country: Germany
facility: Nycomed Deutschland GmbH
city: Velbert
country: Germany
facility: Nycomed Deutschland GmbH
city: Villingen-Schwenningen
country: Germany
facility: Nycomed Deutschland GmbH
city: Wedel
country: Germany
facility: Nycomed Deutschland GmbH
city: Weinsberg
country: Germany
facility: Nycomed Deutschland GmbH
city: Werdau
country: Germany
facility: Nycomed Deutschland GmbH
city: Wesendorf
country: Germany
facility: Nycomed Deutschland GmbH
city: Westhausen
country: Germany
facility: Nycomed Deutschland GmbH
city: Wiesbaden
country: Germany
facility: Nycomed Deutschland GmbH
city: Wiesbaden
country: Germany
facility: Nycomed Deutschland GmbH
city: Wilster
country: Germany
facility: Nycomed Deutschland GmbH
city: Zwickau
country: Germany
facility: Nycomed Deutschland GmbH
city: Zwönitz
country: Germany
facility: Nycomed Deutschland GmbH
Study officials:
affiliation: Nycomed Deutschland GmbH, 78467 Konstanz, Germany
name: Dr. Thomas D. Bethke, PhD; MD
role: STUDY_DIRECTOR
References: