Instanyl® Non-Interventional Study

NCT ID: NCT01045603

Last Updated: 2012-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

309 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-12-31

Study Completion Date

2012-04-30

Brief Summary

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The aim of this study is to describe the use of Instanyl® (Intranasal fentanyl spray) in the treatment of breakthrough pain (BTP) in cancer patients by success of dose titration and distribution of dose strength. Data will be collected at three different time points over a 3 month period.

Detailed Description

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Conditions

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Breakthrough Cancer Pain

Keywords

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Instanyl non-interventional breakthrough cancer pain BTP BTCP Intranasal fentanyl spray

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Adult cancer patients suffering from BTP
* Instanyl should be prescribed in accordance with the Summary of Product Characteristics (SPC) and none of the stated contradictions applies
* The decision to prescribe should be made independently of the study
* All patients must provide signed Informed Consent prior to inclusion
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Takeda

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nycomed Clinical Trial Operations

Role: STUDY_CHAIR

Headquarters

Locations

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Investigational site

Copenhagen, , Denmark

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Herning, , Denmark

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Hillerød, , Denmark

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Randers, , Denmark

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Aix-en-Provence, , France

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Amiens, , France

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Argenteuil, , France

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Auxerre, , France

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Besançon, , France

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Blois, , France

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Bobigny, , France

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Bordeaux, , France

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Brest, , France

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Colmar, , France

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Eaubonne, , France

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Frelinghien, , France

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Grenoble, , France

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Lisieux, , France

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Lorient, , France

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Lyon, , France

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Montbéliard, , France

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Mulhouse, , France

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Nancy, , France

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Nantes, , France

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Orléans, , France

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Paris, , France

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Paris, , France

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Paris, , France

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Pierre-Bénite, , France

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Pontoise, , France

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Saint-Herblain, , France

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Strasbourg, , France

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Strasbourg, , France

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Tarbes, , France

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Toulouse, , France

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Vandœuvre-lès-Nancy, , France

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Athens, , Greece

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Athens, , Greece

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Cork, , Ireland

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Kilkenny, , Ireland

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Bergen, , Norway

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Bergen, , Norway

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Bodø, , Norway

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Fredrikstad, , Norway

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Haugesund, , Norway

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Kristiansand, , Norway

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Lørenskog, , Norway

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Oslo, , Norway

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Oslo, , Norway

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Oslo, , Norway

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Stavanger, , Norway

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Tromsø, , Norway

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Alingsås, , Sweden

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Stockholm, , Sweden

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Sundsvall, , Sweden

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Täby, , Sweden

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Uppsala, , Sweden

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Västervik, , Sweden

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Belfast, , United Kingdom

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Lanarkshire, , United Kingdom

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Luton, , United Kingdom

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Manchester, , United Kingdom

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Middlesex, , United Kingdom

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Suffolk, , United Kingdom

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Wiltshire, , United Kingdom

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Countries

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Denmark France Greece Ireland Norway Sweden United Kingdom

Other Identifiers

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U1111-1136-4251

Identifier Type: REGISTRY

Identifier Source: secondary_id

FT-1301-034-SP

Identifier Type: -

Identifier Source: org_study_id