Instanyl® Non-Interventional Study (INIS)

October 26, 2012 updated by: Takeda

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

309

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100
        • Investigational Site
      • Herning, Denmark, 7400
        • Investigational Site
      • Hillerød, Denmark, 3400
        • Investigational Site
      • Randers, Denmark, 8930
        • Investigational Site
  • France
      • Aix en Provence, France, 13616
        • Investigational Site
      • Amiens, France, 80054
        • Investigational Site
      • Argenteuil, France, 95107
        • Investigational Site
      • Auxerre Cedex, France, 89011
        • Investigational Site
      • Besançon, France, 25030
        • Investigational Site
      • Blois, France, 41000
        • Investigational Site
      • Bobigny Cedex, France, 93009
        • Investigational Site
      • Bordeaux, France, 33076
        • Investigational Site
      • Brest Cedex, France, 29609
        • Investigational Site
      • Colmar, France, 68024
        • Investigational Site
      • Eaubonne Cedex, France, 95602
        • Investigational Site
      • Frelinghien, France, 59236
        • Investigational Site
      • Grenoble, France, 38700
        • Investigational Site
      • Lisieux, France, 14107
        • Investigational Site
      • Lorient Cedex, France, 56324
        • Investigational Site
      • Lyon, France, 69008
        • Investigational Site
      • Montbéliard, France, 25200
        • Investigational Site
      • Mulhouse, France, 68100
        • Investigational Site
      • Nancy, France, 54100
        • Investigational Site
      • Nantes Cedex, France, 44202
        • Investigational Site
      • Orleans Cedex, France, 45031
        • Investigational Site
      • Paris, France, 75010
        • Investigational Site
      • Paris, France, 75181
        • Investigational Site
      • Paris Cedex 20, France, 75970
        • Investigational Site
      • Pierre-Benite, France, 69495
        • Investigational Site
      • Pontoise Cedex, France, 95303
        • Investigational Site
      • St Herblain Cedex, France, 44805
        • Investigational Site
      • Strasbourg, France, 67000
        • Investigational Site
      • Strasbourg, France, 67065
        • Investigational Site
      • Tarbes, France, 65000
        • Investigational Site
      • Toulouse, France, 31059
        • Investigational Site
      • Vandoeuvre les Nancy Cedex, France, 54511
        • Investigational Site
  • Greece
      • Athens, Greece, 11527
        • Investigational Site
      • Athens, Greece, 18547
        • Investigational Site
  • Ireland
      • Cork, Ireland
        • Investigational Site
      • Kilkenny, Ireland
        • Investigational Site
  • Norway
      • Bergen, Norway, 5009
        • Investigational Site
      • Bergen, Norway, 5012
        • Investigational Site
      • Bodø, Norway, 8092
        • Investigational Site
      • Fredrikstad, Norway, 1603
        • Investigational Site
      • Haugesund, Norway, 5504
        • Investigational Site
      • Kristiansand, Norway, 4910
        • Investigational Site
      • Lørenskog, Norway, 1478
        • Investigational Site
      • Oslo, Norway, 0310
        • Investigational Site
      • Oslo, Norway, 0407
        • Investigational Site
      • Oslo, Norway, 0514
        • Investigational Site
      • Stavanger, Norway, 4068
        • Investigational Site
      • Tromsø, Norway, 9038
        • Investigational Site
  • Sweden
      • Alingsås, Sweden, 441 83
        • Investigational Site
      • Stockholm, Sweden, 112 35
        • Investigational Site
      • Sundsvall, Sweden, 852 40
        • Investigational Site
      • Täby, Sweden, 187 77
        • Investigational Site
      • Uppsala, Sweden, 751 85
        • Investigational Site
      • Västervik, Sweden, 593 81
        • Investigational Site
  • United Kingdom
      • Belfast, United Kingdom, BT5 6NF
        • Investigational Site
      • Lanarkshire, United Kingdom, ML6 6DJ
        • Investigational Site
      • Luton, United Kingdom, LU4 0DT
        • Investigational Site
      • Manchester, United Kingdom, M20 4BX
        • Investigational Site
      • Middlesex, United Kingdom, HA6 2RN
        • Investigational Site
      • Suffolk, United Kingdom, IP3 8LX
        • Investigational Site
      • Wiltshire, United Kingdom, BA15 2LE
        • Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

  • 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Success of titration (Y/N), defined as reaching a maintenance dose
Time Frame: At week 4 and month 3 after baseline
At week 4 and month 3 after baseline
Dose level of Instanyl® after titration, defined as the maintenance dose
Time Frame: At week 4 and month 3 after baseline
At week 4 and month 3 after baseline

Secondary Outcome Measures

Outcome Measure
Time Frame
Adverse Drug Reactions (ADR)
Time Frame: At week 4 and month 3 after baseline
At week 4 and month 3 after baseline
Reason and time for Instanyl® termination
Time Frame: At week 4 and month 3 after baseline
At week 4 and month 3 after baseline
Change in Instanyl® maintenance dose
Time Frame: At week 4 and month 3 after baseline
At week 4 and month 3 after baseline
Change in level of background medication (standardised daily dose)
Time Frame: At week 4 and month 3 after baseline
At week 4 and month 3 after baseline
Pain, pain relief and impact of pain of daily life
Time Frame: At baseline and week 4
At baseline and week 4
Treatment satisfaction
Time Frame: At baseline and week 4
At baseline and week 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Takeda

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

January 8, 2010

First Submitted That Met QC Criteria

January 8, 2010

First Posted (Estimate)

January 11, 2010

Study Record Updates

Last Update Posted (Estimate)

October 29, 2012

Last Update Submitted That Met QC Criteria

October 26, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FT-1301-034-SP
  • U1111-1136-4251 (Registry Identifier: WHO)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breakthrough Cancer Pain

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Brazil

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe