Clinical trial NCT01045603: Instanyl® Non-Interventional Study
Official title: A 3 Month Observational Prospective Patient Cohort Study of the Treatment of Breakthrough Pain in Cancer Patients With Instanyl®
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breakthrough Cancer Pain
Keywords: Instanyl
non-interventional
breakthrough cancer pain
BTP
BTCP
Intranasal fentanyl spray
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2010-01-11
Enrollment: 309
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: 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.

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.


Eligibility 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

Primary outcomes:
measure: Success of titration (Y/N), defined as reaching a maintenance dose
timeFrame: At week 4 and month 3 after baseline
measure: Dose level of Instanyl® after titration, defined as the maintenance dose
timeFrame: At week 4 and month 3 after baseline
Secondary outcomes:
measure: Adverse Drug Reactions (ADR)
timeFrame: At week 4 and month 3 after baseline
measure: Reason and time for Instanyl® termination
timeFrame: At week 4 and month 3 after baseline
measure: Change in Instanyl® maintenance dose
timeFrame: At week 4 and month 3 after baseline
measure: Change in level of background medication (standardised daily dose)
timeFrame: At week 4 and month 3 after baseline
measure: Pain, pain relief and impact of pain of daily life
timeFrame: At baseline and week 4
measure: Treatment satisfaction
timeFrame: At baseline and week 4
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Investigational site
city: Herning
country: Denmark
facility: Investigational site
city: Hillerød
country: Denmark
facility: Investigational site
city: Randers
country: Denmark
facility: Investigational site
city: Aix en Provence
country: France
facility: Investigational site
city: Amiens
country: France
facility: Investigational site
city: Argenteuil
country: France
facility: Investigational site
city: Auxerre Cedex
country: France
facility: Investigational site
city: Besançon
country: France
facility: Investigational site
city: Blois
country: France
facility: Investigational site
city: Bobigny Cedex
country: France
facility: Investigational site
city: Bordeaux
country: France
facility: Investigational site
city: Brest Cedex
country: France
facility: Investigational site
city: Colmar
country: France
facility: Investigational site
city: Eaubonne Cedex
country: France
facility: Investigational site
city: Frelinghien
country: France
facility: Investigational site
city: Grenoble
country: France
facility: Investigational site
city: Lisieux
country: France
facility: Investigational site
city: Lorient Cedex
country: France
facility: Investigational site
city: Lyon
country: France
facility: Investigational site
city: Montbéliard
country: France
facility: Investigational site
city: Mulhouse
country: France
facility: Investigational site
city: Nancy
country: France
facility: Investigational site
city: Nantes Cedex
country: France
facility: Investigational site
city: Orleans Cedex
country: France
facility: Investigational site
city: Paris Cedex 20
country: France
facility: Investigational site
city: Paris
country: France
facility: Investigational site
city: Paris
country: France
facility: Investigational site
city: Pierre-Benite
country: France
facility: Investigational site
city: Pontoise Cedex
country: France
facility: Investigational site
city: St Herblain Cedex
country: France
facility: Investigational site
city: Strasbourg
country: France
facility: Investigational site
city: Strasbourg
country: France
facility: Investigational site
city: Tarbes
country: France
facility: Investigational site
city: Toulouse
country: France
facility: Investigational site
city: Vandoeuvre les Nancy Cedex
country: France
facility: Investigational site
city: Athens
country: Greece
facility: Investigational site
city: Athens
country: Greece
facility: Investigational site
city: Cork
country: Ireland
facility: Investigational site
city: Kilkenny
country: Ireland
facility: Investigational site
city: Bergen
country: Norway
facility: Investigational site
city: Bergen
country: Norway
facility: Investigational site
city: Bodø
country: Norway
facility: Investigational site
city: Fredrikstad
country: Norway
facility: Investigational site
city: Haugesund
country: Norway
facility: Investigational site
city: Kristiansand
country: Norway
facility: Investigational site
city: Lørenskog
country: Norway
facility: Investigational site
city: Oslo
country: Norway
facility: Investigational site
city: Oslo
country: Norway
facility: Investigational site
city: Oslo
country: Norway
facility: Investigational site
city: Stavanger
country: Norway
facility: Investigational site
city: Tromsø
country: Norway
facility: Investigational site
city: Alingsås
country: Sweden
facility: Investigational site
city: Stockholm
country: Sweden
facility: Investigational site
city: Sundsvall
country: Sweden
facility: Investigational site
city: Täby
country: Sweden
facility: Investigational site
city: Uppsala
country: Sweden
facility: Investigational site
city: Västervik
country: Sweden
facility: Investigational site
city: Belfast
country: United Kingdom
facility: Investigational site
city: Lanarkshire
country: United Kingdom
facility: Investigational site
city: Luton
country: United Kingdom
facility: Investigational site
city: Manchester
country: United Kingdom
facility: Investigational site
city: Middlesex
country: United Kingdom
facility: Investigational site
city: Suffolk
country: United Kingdom
facility: Investigational site
city: Wiltshire
country: United Kingdom
facility: Investigational site
Study officials:
affiliation: Headquarters
name: Nycomed Clinical Trial Operations
role: STUDY_CHAIR
References: