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

NCT00994760 | Completed Results

• 1 other identifier: FT-1301-401-DE
• Study Type: observational
• Target: 131
• Locations: 1 country
• Sites: 168

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.

Conditions

Breakthrough Pain; Cancer

Keywords

intranasal fentanyl spray

Outcome Measures

Primary Outcomes (6)

• 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 (18)

• Physician: Degree of Relief of Breakthrough Pain Achieved by Instanyl at Study End

  after therapy with Instanyl (planned: 4 weeks)

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

  initial visit (before start of therapy with Instanyl)

• Patient: Description of Pain at Initial Visit

  initial visit (before start of therapy with Instanyl)

• Patient: How do You Feel Today?

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

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

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

Study Arms (1)

GENISIS

Drug: Instanyl (Intranasal Fentanyl)

Interventions

Instanyl (Intranasal Fentanyl) DRUG

This was an observational study. Therefore, the physician decided about dosage according to individual needs.

GENISIS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Outpatients

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Takeda: lead

Study Sites (168)

Nycomed Deutschland GmbH

Aachen, 52074, Germany

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Nycomed Deutschland GmbH

Adendorf, 21365, Germany

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Nycomed Deutschland GmbH

Aichach, 86551, Germany

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Nycomed Deutschland GmbH

Albstadt, 72458, Germany

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Nycomed Deutschland GmbH

Albstadt-Ebingen, 72458, Germany

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Nycomed Deutschland GmbH

Altenkirchen, 57610, Germany

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Nycomed Deutschland GmbH

Aschaffenburg, 63743, Germany

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Nycomed Deutschland GmbH

Aschersleben, 06449, Germany

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Nycomed Deutschland GmbH

Augsburg, 86150, Germany

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Nycomed Deutschland GmbH

Augsburg, 86163, Germany

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Nycomed Deutschland GmbH

Backnang, 71522, Germany

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Nycomed Deutschland GmbH

Bad Bevensen, 29545, Germany

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Nycomed Deutschland GmbH

Bad Dürkheim, 67098, Germany

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Nycomed Deutschland GmbH

Bad Liebenstein, 36448, Germany

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Nycomed Deutschland GmbH

Bad Pyrmont, 31812, Germany

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Nycomed Deutschland GmbH

Bad Schwalbach, 65307, Germany

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Nycomed Deutschland GmbH

Badel, 39624, Germany

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Nycomed Deutschland GmbH

Bademühlen, 27404, Germany

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Nycomed Deutschland GmbH

Bautzen, 02625, Germany

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Nycomed Deutschland GmbH

Berlin, 10317, Germany

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Nycomed Deutschland GmbH

Berlin, 10409, Germany

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Nycomed Deutschland GmbH

Berlin, 10437, Germany

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Nycomed Deutschland GmbH

Berlin, 10713, Germany

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Nycomed Deutschland GmbH

Berlin, 10715, Germany

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Nycomed Deutschland GmbH

Berlin, 10999, Germany

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Nycomed Deutschland GmbH

Berlin, 12107, Germany

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Nycomed Deutschland GmbH

Berlin, 12627, Germany

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Nycomed Deutschland GmbH

Berlin, 13055, Germany

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Nycomed Deutschland GmbH

Bochum, 44801, Germany

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Nycomed Deutschland GmbH

Bonn, 53177, Germany

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Nycomed Deutschland GmbH

Böblingen, 71034, Germany

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Nycomed Deutschland GmbH

Brandenburg/Havel, 14776, Germany

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Nycomed Deutschland GmbH

Braunschweig, 38100, Germany

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Nycomed Deutschland GmbH

Bremen, 28329, Germany

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Nycomed Deutschland GmbH

Brühl, 50321, Germany

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Nycomed Deutschland GmbH

Burg, 39288, Germany

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Nycomed Deutschland GmbH

Burg/Fehmarn, 23769, Germany

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Nycomed Deutschland GmbH

Burscheid, 51399, Germany

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Nycomed Deutschland GmbH

Butzbach, 35510, Germany

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Nycomed Deutschland GmbH

Coburg, 96450, Germany

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Nycomed Deutschland GmbH

Cochem, 56812, Germany

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Nycomed Deutschland GmbH

Cologne, 50733, Germany

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Nycomed Deutschland GmbH

Cologne, 50935, Germany

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Nycomed Deutschland GmbH

Cologne, 50937, Germany

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Nycomed Deutschland GmbH

Cologne, 50996, Germany

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Nycomed Deutschland GmbH

Cologne, 50997, Germany

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Nycomed Deutschland GmbH

Cologne, 51065, Germany

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Nycomed Deutschland GmbH

Cologne, 51103, Germany

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Nycomed Deutschland GmbH

Cottbus, 03050, Germany

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Nycomed Deutschland GmbH

Cuxhaven, 27472, Germany

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Nycomed Deutschland GmbH

Cuxhaven, 27474, Germany

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Nycomed Deutschland GmbH

Dessau, 06846, Germany

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Nycomed Deutschland GmbH

Dresden, 01127, Germany

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Nycomed Deutschland GmbH

Dresden, 01307, Germany

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Nycomed Deutschland GmbH

Dresden, 01309, Germany

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Nycomed Deutschland GmbH

Duisburg, 47137, Germany

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Nycomed Deutschland GmbH

Düsseldorf, 40589, Germany

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Nycomed Deutschland GmbH

Essen, 45326, Germany

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Nycomed Deutschland GmbH

Etzenricht, 92694, Germany

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Nycomed Deutschland GmbH

Fehmarn, 23769, Germany

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Nycomed Deutschland GmbH

Frankfurt, 60311, Germany

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Nycomed Deutschland GmbH

Frankfurt, 60313, Germany

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Nycomed Deutschland GmbH

Frankfurt, 60590, Germany

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Nycomed Deutschland GmbH

Freiburg im Breisgau, 79108, Germany

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Nycomed Deutschland GmbH

Friedberg, 86316, Germany

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Nycomed Deutschland GmbH

Geesthacht, 21502, Germany

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Nycomed Deutschland GmbH

Göppingen, 73033, Germany

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Nycomed Deutschland GmbH

Görlitz, 02826, Germany

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Nycomed Deutschland GmbH

Großheirath-Rossach, 96269, Germany

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Nycomed Deutschland GmbH

Gütersloh, 33330, Germany

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Nycomed Deutschland GmbH

Hachenburg, 57627, Germany

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Nycomed Deutschland GmbH

Hainburg, 63512, Germany

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Nycomed Deutschland GmbH

Halle, 06110, Germany

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Nycomed Deutschland GmbH

Halle, 06120, Germany

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Nycomed Deutschland GmbH

Hamburg, 20095, Germany

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Nycomed Deutschland GmbH

Hamburg, 22765, Germany

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Nycomed Deutschland GmbH

Hamelin, 31785, Germany

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Nycomed Deutschland GmbH

Hanover, 30161, Germany

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Nycomed Deutschland GmbH

Hanover, 30167, Germany

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Nycomed Deutschland GmbH

Hanover, 30625, Germany

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Nycomed Deutschland GmbH

Heidelberg, 69115, Germany

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Nycomed Deutschland GmbH

Hellenthal, 53940, Germany

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Nycomed Deutschland GmbH

Herne, 44625, Germany

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Nycomed Deutschland GmbH

Herzlake, 49770, Germany

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Nycomed Deutschland GmbH

Hohberg, 77749, Germany

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Nycomed Deutschland GmbH

Hohberg-Hofweiler, 77749, Germany

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Nycomed Deutschland GmbH

Holzminden, 37603, Germany

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Nycomed Deutschland GmbH

Husum, 25813, Germany

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Nycomed Deutschland GmbH

Iserlohn, 58638, Germany

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Nycomed Deutschland GmbH

Itzehoe, 25524, Germany

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Nycomed Deutschland GmbH

Jerichow, 39319, Germany

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Nycomed Deutschland GmbH

Kaiserslautern, 67655, Germany

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Nycomed Deutschland GmbH

Karlsbad, 76307, Germany

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Nycomed Deutschland GmbH

Katzhütte, 98746, Germany

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Nycomed Deutschland GmbH

Kevelaar, 47625, Germany

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Nycomed Deutschland GmbH

Kiel, 24105, Germany

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Nycomed Deutschland GmbH

Kiel, 24106, Germany

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Nycomed Deutschland GmbH

Kiel, 24149, Germany

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Nycomed Deutschland GmbH

Kirchberg, 08107, Germany

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Nycomed Deutschland GmbH

Koblenz, 56068, Germany

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Nycomed Deutschland GmbH

Koblenz, 56072, Germany

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Nycomed Deutschland GmbH

Köthen, 06366, Germany

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Nycomed Deutschland GmbH

Krefeld, 47798, Germany

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Nycomed Deutschland GmbH

Krefeld, 47799, Germany

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Nycomed Deutschland GmbH

Krefeld, 47803, Germany

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Nycomed Deutschland GmbH

Laatzen, 30880, Germany

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Nycomed Deutschland GmbH

Lage/Lippe, 32791, Germany

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Nycomed Deutschland GmbH

Landshut, 84036, Germany

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Nycomed Deutschland GmbH

Leipzig, 04159, Germany

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Nycomed Deutschland GmbH

Leverkusen, 51381, Germany

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Nycomed Deutschland GmbH

Ludwigshafen, 67071, Germany

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Nycomed Deutschland GmbH

Magdeburg, 39110, Germany

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Nycomed Deutschland GmbH

Magdeburg, 39112, Germany

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Nycomed Deutschland GmbH

Magdeburg, 39116, Germany

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Nycomed Deutschland GmbH

Mainz, 55116, Germany

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Nycomed Deutschland GmbH

Mannheim, 63167, Germany

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Nycomed Deutschland GmbH

Mannheim, 68165, Germany

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Nycomed Deutschland GmbH

Mayen, 56727, Germany

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Nycomed Deutschland GmbH

Meinersen, 38536, Germany

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Nycomed Deutschland GmbH

München, 80538, Germany

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Nycomed Deutschland GmbH

Nastätten, 56355, Germany

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Nycomed Deutschland GmbH

Naumburg, 06618, Germany

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Nycomed Deutschland GmbH

Neubrandenburg, 17022, Germany

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Nycomed Deutschland GmbH

Neubrandenburg, 17033, Germany

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Nycomed Deutschland GmbH

Neuss, 41460, Germany

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Nycomed Deutschland GmbH

Neustadt, 01844, Germany

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Nycomed Deutschland GmbH

Neustadt, 67434, Germany

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Nycomed Deutschland GmbH

Nordhorn, 48529, Germany

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Nycomed Deutschland GmbH

Olpe, 57462, Germany

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Nycomed Deutschland GmbH

Osloß, 38557, Germany

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Nycomed Deutschland GmbH

Osnabrück, 49074, Germany

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Nycomed Deutschland GmbH

Osnabrück, 49076, Germany

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Nycomed Deutschland GmbH

Pforzheim, 75172, Germany

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Nycomed Deutschland GmbH

Plate, 19086, Germany

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Nycomed Deutschland GmbH

Plüderhausen, 73655, Germany

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Nycomed Deutschland GmbH

Potsdam, 14467, Germany

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Nycomed Deutschland GmbH

Potsdam-Babelsberg, 14482, Germany

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Nycomed Deutschland GmbH

Pulheim-Stommeln, 50259, Germany

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Nycomed Deutschland GmbH

Quedlinburg, 06484, Germany

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Nycomed Deutschland GmbH

Rheine, 48431, Germany

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Nycomed Deutschland GmbH

Rosenfeld, 72348, Germany

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Nycomed Deutschland GmbH

Rostock, 18055, Germany

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Nycomed Deutschland GmbH

Rostock, 18107, Germany

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Nycomed Deutschland GmbH

Rostock, 18109, Germany

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Nycomed Deutschland GmbH

Sangerhausen, 06526, Germany

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Nycomed Deutschland GmbH

Sankt Michaelisdonn, 25693, Germany

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Nycomed Deutschland GmbH

Schleswig, 24837, Germany

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Nycomed Deutschland GmbH

Siegen, 57072, Germany

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Nycomed Deutschland GmbH

Solingen, 42659, Germany

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Nycomed Deutschland GmbH

Stendal, 39576, Germany

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Nycomed Deutschland GmbH

Stuttgart, 70619, Germany

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Nycomed Deutschland GmbH

Tangermünde, 39590, Germany

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Nycomed Deutschland GmbH

Ulm, 89073, Germany

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Nycomed Deutschland GmbH

Ulm, 89075, Germany

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Nycomed Deutschland GmbH

Ulm, 89077, Germany

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Nycomed Deutschland GmbH

Varel, 26316, Germany

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Nycomed Deutschland GmbH

Velbert, 42551, Germany

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Nycomed Deutschland GmbH

Villingen-Schwenningen, 78054, Germany

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Nycomed Deutschland GmbH

Wedel, 22880, Germany

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Nycomed Deutschland GmbH

Weinsberg, 74189, Germany

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Nycomed Deutschland GmbH

Werdau, 08412, Germany

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Nycomed Deutschland GmbH

Wesendorf, 29392, Germany

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Nycomed Deutschland GmbH

Westhausen, 73463, Germany

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Nycomed Deutschland GmbH

Wiesbaden, 65189, Germany

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Nycomed Deutschland GmbH

Wiesbaden, 65191, Germany

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Nycomed Deutschland GmbH

Wilster, 25554, Germany

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Nycomed Deutschland GmbH

Zwickau, 08056, Germany

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Nycomed Deutschland GmbH

Zwönitz, 08297, Germany

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MeSH Terms

Conditions

Breakthrough Pain; Neoplasms

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Medical Responsible
• Organization: Nycomed Deutschland GmbH

clinicaltrials@nycomed.com

+49 7531 3666

Study Officials

• Dr. Thomas D. Bethke, PhD; MD

  Nycomed Deutschland GmbH, 78467 Konstanz, Germany

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2009
• First Posted: October 14, 2009
• Study Start: September 1, 2009
• Primary Completion: September 1, 2010
• Study Completion: November 1, 2010
• Last Updated: September 27, 2012
• Results First Posted: September 27, 2012

Record last verified: 2012-08

Locations

DE (168)