Trial Information
A 3 Month Observational Prospective Patient Cohort Study of the Treatment of Breakthrough Pain in Cancer Patients With Instanyl®
Inclusion 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
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
Success of titration (Y/N), defined as reaching a maintenance dose
Outcome Time Frame:
At week 4 and month 3 after baseline
Safety Issue:
No
Principal Investigator
Nycomed Clinical Trial Operations
Investigator Role:
Study Chair
Investigator Affiliation:
Headquarters
Authority:
Ireland: Research Ethics Committee
Study ID:
FT-1301-034-SP
NCT ID:
NCT01045603
Start Date:
December 2009
Completion Date:
April 2012
Related Keywords:
- Breakthrough Cancer Pain
- Instanyl
- non-interventional
- breakthrough cancer pain
- BTP
- BTCP
- Intranasal fentanyl spray