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Instanyl® Non-Interventional Study (INIS)

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

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 ]
  • Dose level of Instanyl® after titration, defined as the maintenance dose [ Time Frame: At week 4 and month 3 after baseline ]

Secondary Outcome Measures:
  • Adverse Drug Reactions (ADR) [ Time Frame: At week 4 and month 3 after baseline ]
  • Reason and time for Instanyl® termination [ Time Frame: At week 4 and month 3 after baseline ]
  • Change in Instanyl® maintenance dose [ Time Frame: 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 ]
  • Pain, pain relief and impact of pain of daily life [ Time Frame: At baseline and week 4 ]
  • Treatment satisfaction [ Time Frame: At baseline and week 4 ]

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   (Adult, Senior)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01045603     History of Changes
Other Study ID Numbers: FT-1301-034-SP
U1111-1136-4251 ( Registry Identifier: WHO )
Study First Received: January 8, 2010
Last Updated: October 26, 2012

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

ClinicalTrials.gov processed this record on June 22, 2017