Efficacy and Tolerability of Intranasal Fentanyl Spray for the Treatment of Breakthrough Pain in Cancer Patients Older Than 18 Years - Full Text View

Sponsor:	Nycomed
Information provided by (Responsible Party):	Nycomed
ClinicalTrials.gov Identifier:	NCT00994760

Purpose

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.

Condition	Intervention
Breakthrough Pain Cancer	Drug: Instanyl (Intranasal Fentanyl)

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
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.

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Fentanyl Fentanyl Citrate

U.S. FDA Resources

Further study details as provided by Nycomed:

Primary Outcome Measures:

pharmacoeconomic efficiency of INFS in the treatment of cancer-related breakthrough pain (BTP) attacks by reproducible treatment success [ Time Frame: during four weeks of treatment period ] [ Designated as safety issue: No ]
INFS-related reduction of health-/home-/family-care resource utilization [ Time Frame: during four weeks of treatment period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

analgetic efficacy of INFS for BTP by success of titration, distribution of dose strength, time-specific improvement rates, and in comparison to alternative treatment regimes [ Time Frame: during four weeks of treatment period ] [ Designated as safety issue: No ]
Safety and tolerability of instanyl through reporting of adverse drug reactions [ Time Frame: during four weeks of treatment period ] [ Designated as safety issue: Yes ]
quality of life [ Time Frame: during four weeks of treatment period ] [ Designated as safety issue: No ]

Estimated Enrollment:	500
Study Start Date:	September 2009
Study Completion Date:	November 2010
Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
GENISIS	Drug: Instanyl (Intranasal Fentanyl) This is an observational study. Therefore, the physician decides about dosage according to individual needs.

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

Outpatients

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00994760

Show 168 Study Locations

Sponsors and Collaborators

Nycomed

Investigators

Study Director:

Dr. Thomas D. Bethke, PhD; MD

Nycomed Deutschland GmbH, 78467 Konstanz, Germany

More Information

No publications provided

Responsible Party:	Nycomed
ClinicalTrials.gov Identifier:	NCT00994760 History of Changes
Other Study ID Numbers:	FT-1301-401-DE
Study First Received:	October 5, 2009
Last Updated:	September 20, 2011
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Nycomed:

intranasal fentanyl spray

Additional relevant MeSH terms:

Fentanyl
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs

Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Opioid

ClinicalTrials.gov processed this record on February 09, 2012