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A Prospective Non-interventional/Observational Patient Cohort Study on the Efficacy of Intranasal Fentanyl Spray for the Treatment of Breakthrough Pain in Cancer Patients.


N/A
18 Years
N/A
Not Enrolling
Both
Breakthrough Pain, Cancer

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Trial Information

A Prospective Non-interventional/Observational Patient Cohort Study on the Efficacy of Intranasal Fentanyl Spray for the Treatment of Breakthrough Pain in Cancer Patients.

Inclusion Criteria


Inclusion criteria:

- decision to start treatment with intranasal fentanyl spray

- written informed consent

Exclusion criteria:

- criteria as defined in the Summary of Product Characteristics (Fachinformation
Chapter 4.3)

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Dose of Instanyl

Outcome Description:

Initially prescribed dose/ most efficient single dose of Instanyl at study end

Outcome Time Frame:

during therapy with Instanyl (planned: 28 days)

Safety Issue:

No

Principal Investigator

Dr. Thomas D. Bethke, PhD; MD

Investigator Role:

Study Director

Investigator Affiliation:

Nycomed Deutschland GmbH, 78467 Konstanz, Germany

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

FT-1301-401-DE

NCT ID:

NCT00994760

Start Date:

September 2009

Completion Date:

November 2010

Related Keywords:

  • Breakthrough Pain
  • Cancer
  • intranasal fentanyl spray

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