Efficacy and Tolerability of Intranasal Fentanyl Spray for the Treatment of Breakthrough Pain in Cancer Patients Older Than 18 Years
Information source: Nycomed
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Breakthrough Pain; Cancer
Intervention: Instanyl (Intranasal Fentanyl) (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Nycomed Official(s) and/or principal investigator(s):
Dr. Thomas D. Bethke, PhD; MD, Study Director, Affiliation: Nycomed Deutschland GmbH, 78467 Konstanz, Germany
Overall contact:
Nycomed Info, Email: info@nycomed.com
Summary
The aim of the study is to evaluate the safety and efficacy of intranasal fentanyl spray in
cancer patients over four weeks, especially during cancer-related breakthrough pain (BTP)
attacks. The fentanyl spray will be applied into the nose by a metered-spray device. The
study will provide further data on pharmacoeconomic efficiency of intranasal fentanyl spray.
Clinical Details
Official title: A Prospective Non-interventional/Observational Patient Cohort Study on the Efficacy of Intranasal Fentanyl Spray for the Treatment of Breakthrough Pain in Cancer Patients.
Study design: Cohort, Prospective
Primary outcome: pharmacoeconomic efficiency of INFS in the treatment of cancer-related breakthrough pain (BTP) attacks by reproducible treatment successINFS-related reduction of health-/home-/family-care resource utilization
Secondary outcome: analgetic efficacy of INFS for BTP by success of titration, distribution of dose strength, time-specific improvement rates, and in comparison to alternative treatment regimesSafety and tolerability of instanyl through reporting of adverse drug reactions quality of life
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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)
Locations and Contacts
Nycomed Info, Email: info@nycomed.com
Nycomed Deutschland GmbH, Hamburg 20123, Germany; Recruiting
Additional Information
Starting date: September 2009
Ending date: August 2010
Last updated: October 13, 2009
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