Instanyl® Non-Interventional Study

Breakthrough Cancer Pain Clinical Trial

— INIS  

Official title:

A 3 Month Observational Prospective Patient Cohort Study of the Treatment of Breakthrough Pain in Cancer Patients With Instanyl®

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01045603
• Other study ID #: FT-1301-034-SP
• Secondary ID: U1111-1136-4251
• Status: Completed
• Phase: N/A
• First received: January 8, 2010
• Last updated: October 26, 2012
• Start date: December 2009
• Est. completion date: April 2012

Study information

• Verified date: October 2012
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ireland: Research Ethics CommitteeNorway:National Committee for Medical and Health Research EthicsSweden: Regional Ethical Review BoardUnited Kingdom: Research Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 309
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

• 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breakthrough Cancer Pain
• Breakthrough Pain

Locations

Country	Name	City	State
Denmark	Investigational site	Copenhagen
Denmark	Investigational site	Herning
Denmark	Investigational site	Hillerød
Denmark	Investigational site	Randers
France	Investigational site	Aix en Provence
France	Investigational site	Amiens
France	Investigational site	Argenteuil
France	Investigational site	Auxerre Cedex
France	Investigational site	Besançon
France	Investigational site	Blois
France	Investigational site	Bobigny Cedex
France	Investigational site	Bordeaux
France	Investigational site	Brest Cedex
France	Investigational site	Colmar
France	Investigational site	Eaubonne Cedex
France	Investigational site	Frelinghien
France	Investigational site	Grenoble
France	Investigational site	Lisieux
France	Investigational site	Lorient Cedex
France	Investigational site	Lyon
France	Investigational site	Montbéliard
France	Investigational site	Mulhouse
France	Investigational site	Nancy
France	Investigational site	Nantes Cedex
France	Investigational site	Orleans Cedex
France	Investigational site	Paris
France	Investigational site	Paris
France	Investigational site	Paris Cedex 20
France	Investigational site	Pierre-Benite
France	Investigational site	Pontoise Cedex
France	Investigational site	St Herblain Cedex
France	Investigational site	Strasbourg
France	Investigational site	Strasbourg
France	Investigational site	Tarbes
France	Investigational site	Toulouse
France	Investigational site	Vandoeuvre les Nancy Cedex
Greece	Investigational site	Athens
Greece	Investigational site	Athens
Ireland	Investigational site	Cork
Ireland	Investigational site	Kilkenny
Norway	Investigational site	Bergen
Norway	Investigational site	Bergen
Norway	Investigational site	Bodø
Norway	Investigational site	Fredrikstad
Norway	Investigational site	Haugesund
Norway	Investigational site	Kristiansand
Norway	Investigational site	Lørenskog
Norway	Investigational site	Oslo
Norway	Investigational site	Oslo
Norway	Investigational site	Oslo
Norway	Investigational site	Stavanger
Norway	Investigational site	Tromsø
Sweden	Investigational site	Alingsås
Sweden	Investigational site	Stockholm
Sweden	Investigational site	Sundsvall
Sweden	Investigational site	Täby
Sweden	Investigational site	Uppsala
Sweden	Investigational site	Västervik
United Kingdom	Investigational site	Belfast
United Kingdom	Investigational site	Lanarkshire
United Kingdom	Investigational site	Luton
United Kingdom	Investigational site	Manchester
United Kingdom	Investigational site	Middlesex
United Kingdom	Investigational site	Suffolk
United Kingdom	Investigational site	Wiltshire

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Countries where clinical trial is conducted

Denmark,  France,  Greece,  Ireland,  Norway,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success of titration (Y/N), defined as reaching a maintenance dose		At week 4 and month 3 after baseline	No
Primary	Dose level of Instanyl® after titration, defined as the maintenance dose		At week 4 and month 3 after baseline	No
Secondary	Adverse Drug Reactions (ADR)		At week 4 and month 3 after baseline	Yes
Secondary	Reason and time for Instanyl® termination		At week 4 and month 3 after baseline	No
Secondary	Change in Instanyl® maintenance dose		At week 4 and month 3 after baseline	No
Secondary	Change in level of background medication (standardised daily dose)		At week 4 and month 3 after baseline	No
Secondary	Pain, pain relief and impact of pain of daily life		At baseline and week 4	No
Secondary	Treatment satisfaction		At baseline and week 4	No