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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 8, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 8, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 11, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 29, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 26, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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