Instanyl® Non-Interventional Study

NCT01045603 | Completed

• 2 other identifiers: FT-1301-034-SPU1111-1136-4251
• Study Type: observational
• Target: 309
• Locations: 7 countries
• Sites: 65

Brief Summary

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.

Conditions

Breakthrough Cancer Pain

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Success of titration (Y/N), defined as reaching a maintenance dose

  At week 4 and month 3 after baseline

• Dose level of Instanyl® after titration, defined as the maintenance dose

  At week 4 and month 3 after baseline

Secondary Outcomes (6)

• Adverse Drug Reactions (ADR)

  At week 4 and month 3 after baseline

• Reason and time for Instanyl® termination

  At week 4 and month 3 after baseline

• Change in Instanyl® maintenance dose

  At week 4 and month 3 after baseline

• Change in level of background medication (standardised daily dose)

  At week 4 and month 3 after baseline

• Pain, pain relief and impact of pain of daily life

  At baseline and week 4

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

Adult cancer patients (in- or out-patients) that are suffering from BTP who have not been treated with Instanyl for one month prior to Baseline.

* 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Takeda: lead

Study Sites (65)

Investigational site

Copenhagen, 2100, Denmark

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Herning, 7400, Denmark

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Hillerød, 3400, Denmark

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Randers, 8930, Denmark

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Aix-en-Provence, 13616, France

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Amiens, 80054, France

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Argenteuil, 95107, France

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Auxerre, 89011, France

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Besançon, 25030, France

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Blois, 41000, France

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Bobigny, 93009, France

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Bordeaux, 33076, France

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Brest, 29609, France

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Colmar, 68024, France

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Eaubonne, 95602, France

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Frelinghien, 59236, France

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Grenoble, 38700, France

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Lisieux, 14107, France

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Lorient, 56324, France

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Lyon, 69008, France

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Montbéliard, 25200, France

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Mulhouse, 68100, France

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Nancy, 54100, France

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Nantes, 44202, France

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Orléans, 45031, France

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Paris, 75010, France

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Paris, 75181, France

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Paris, 75970, France

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Pierre-Bénite, 69495, France

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Pontoise, 95303, France

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Saint-Herblain, 44805, France

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Strasbourg, 67000, France

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Strasbourg, 67065, France

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Tarbes, 65000, France

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Toulouse, 31059, France

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Vandœuvre-lès-Nancy, 54511, France

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Athens, 11527, Greece

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Athens, 18547, Greece

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Cork, Ireland

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Kilkenny, Ireland

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Bergen, 5009, Norway

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Bergen, 5012, Norway

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Bodø, 8092, Norway

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Fredrikstad, 1603, Norway

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Haugesund, 5504, Norway

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Kristiansand, 4910, Norway

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Lørenskog, 1478, Norway

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Oslo, 0310, Norway

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Oslo, 0407, Norway

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Oslo, 0514, Norway

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Stavanger, 4068, Norway

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Tromsø, 9038, Norway

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Alingsås, 441 83, Sweden

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Stockholm, 112 35, Sweden

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Sundsvall, 852 40, Sweden

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Täby, 187 77, Sweden

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Uppsala, 751 85, Sweden

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Västervik, 593 81, Sweden

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Belfast, BT5 6NF, United Kingdom

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Lanarkshire, ML6 6DJ, United Kingdom

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Luton, LU4 0DT, United Kingdom

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Manchester, M20 4BX, United Kingdom

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Middlesex, HA6 2RN, United Kingdom

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Suffolk, IP3 8LX, United Kingdom

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Wiltshire, BA15 2LE, United Kingdom

Location

Study Officials

• Nycomed Clinical Trial Operations

  Headquarters

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: January 8, 2010
• First Posted: January 11, 2010
• Study Start: December 1, 2009
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: October 29, 2012

Record last verified: 2012-10

Locations

IE (2); GR (2); GB (7); DK (4); FR (32); NO (12); SE (6)