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Instanyl® Non-Interventional Study (INIS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Takeda ( Nycomed: A Takeda Company )
ClinicalTrials.gov Identifier:
NCT01045603
First received: January 8, 2010
Last updated: October 26, 2012
Last verified: October 2012
History of Changes
  Purpose

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.


Condition
Breakthrough Cancer Pain

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A 3 Month Observational Prospective Patient Cohort Study of the Treatment of Breakthrough Pain in Cancer Patients With Instanyl®

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Takeda:

Primary Outcome Measures:
  • Success of titration (Y/N), defined as reaching a maintenance dose [ Time Frame: At week 4 and month 3 after baseline ] [ Designated as safety issue: No ]
  • Dose level of Instanyl® after titration, defined as the maintenance dose [ Time Frame: At week 4 and month 3 after baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse Drug Reactions (ADR) [ Time Frame: At week 4 and month 3 after baseline ] [ Designated as safety issue: Yes ]
  • Reason and time for Instanyl® termination [ Time Frame: At week 4 and month 3 after baseline ] [ Designated as safety issue: No ]
  • Change in Instanyl® maintenance dose [ Time Frame: At week 4 and month 3 after baseline ] [ Designated as safety issue: No ]
  • Change in level of background medication (standardised daily dose) [ Time Frame: At week 4 and month 3 after baseline ] [ Designated as safety issue: No ]
  • Pain, pain relief and impact of pain of daily life [ Time Frame: At baseline and week 4 ] [ Designated as safety issue: No ]
  • Treatment satisfaction [ Time Frame: At baseline and week 4 ] [ Designated as safety issue: No ]

Enrollment: 309
Study Start Date: December 2009
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01045603

  Show 65 Study Locations
Sponsors and Collaborators
Nycomed: A Takeda Company
Investigators
Study Chair: Nycomed Clinical Trial Operations Headquarters
  More Information

No publications provided

Responsible Party: Takeda ( Nycomed: A Takeda Company )
ClinicalTrials.gov Identifier: NCT01045603     History of Changes
Other Study ID Numbers: FT-1301-034-SP, U1111-1136-4251
Study First Received: January 8, 2010
Last Updated: October 26, 2012
Health Authority: Ireland: Research Ethics Committee
Norway:National Committee for Medical and Health Research Ethics
Sweden: Regional Ethical Review Board
United Kingdom: Research Ethics Committee

Keywords provided by Takeda:
Instanyl
non-interventional
breakthrough cancer pain
 BTP
BTCP
Intranasal fentanyl spray

ClinicalTrials.gov processed this record on June 18, 2013