Efficacy & Safety Study of Nasalfent (Fentanyl Citrate Nasal Spray) for Treatment of Breakthrough Cancer Pain in Patients Taking Regular Opioids - Full Text View

Sponsor:	Archimedes Development Ltd
Information provided by (Responsible Party):	Archimedes Development Ltd
ClinicalTrials.gov Identifier:	NCT00459277

Purpose

Cancer patients taking regular medication for their pain often still have episodes of severe pain that 'break through' despite their background pain treatment. Fentanyl is a strong, short-acting pain killer often used to treat this 'breakthrough' pain. Nasalfent contains fentanyl in a patented drug delivery system called PecSys and is given via a simple nasal spray. This study will test the efficacy and safety of Nasalfent in the treatment of breakthrough cancer pain.

Condition	Intervention	Phase
Cancer Pain	Drug: Fentanyl (Nasalfent, Fentanyl Citrate Nasal Spray)	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Supportive Care
Official Title:	A Multicenter, Placebo-Controlled, Double-Blind, Two-Phase Crossover Study of Nasalfent (Fentanyl Citrate Nasal Spray) in the Treatment of Breakthrough Cancer Pain (BTCP) in Subjects Taking Regular Opioid Therapy

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Citric acid Fentanyl Fentanyl Citrate Sodium Citrate

U.S. FDA Resources

Further study details as provided by Archimedes Development Ltd:

Primary Outcome Measures:

Summed pain intensity difference at 30 min [ Time Frame: 30 min after dosing ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

SPID, Pain intensity, Pain intensity difference, Pain relief and Total pain relief [ Time Frame: Various timepoints ] [ Designated as safety issue: No ]

Enrollment:	73
Study Start Date:	December 2006
Study Completion Date:	August 2008
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Nasalfent, Fentanyl Citrate Nasal Spray	Drug: Fentanyl (Nasalfent, Fentanyl Citrate Nasal Spray)
Placebo Comparator: Placebo Spray	Drug: Fentanyl (Nasalfent, Fentanyl Citrate Nasal Spray)

Detailed Description:

Current treatments for breakthrough cancer pain (BTCP) work too slowly to meet the fast onset of most BTCP episodes, they continue to act longer than the episode of pain lasts and so can have unwanted side effects due to this 'over treatment' of the pain episode. In addition most cancer patients have oral problems which make taking pain relief medication by mouth uncomfortable for the patient. Nasalfent is administered via the nose as a simple spray and can be taken by patients or given by their carers. The nasal route is a common way to administer medication for example in the treatment of migraine or allergy. At any time during the study the patient may take their regular treatment for BTCP should they so wish.

This study will compare the time of onset and degree of pain relief of Nasalfent to that of Placebo. The safety of the two treatments groups (Nasalfent, Placebo) will also be examined.

Eligibility

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

Criteria

Inclusion Criteria:

Able and willing to give consent
Women of childbearing potential must have a) negative urine pregnancy test b) not be breast feeding c) agree to practice a reliable form of contraception
Diagnosis of cancer
Taking at least 60mg oral morphine or equivalent as 24 hour treatment for cancer-related pain
Experiencing on average 1 - 4 episodes of breakthrough cancer pain per day usually controlled by rescue pain medication
Able (or via caregiver)to evaluate and record pain relief, assess medication performance at set times after dosing, record adverse events, record each use of the study drug or rescue medication in a diary
Able to be up and about for 50% of the day or greater

Exclusion Criteria:

Intolerance to opioids or fentanyl
rapidly increasing/uncontrolled pain
pain that is not cancer related

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00459277

Locations

United States, New York
Beth Israel Medical Center
New York, New York, United States, 10003

Sponsors and Collaborators

Archimedes Development Ltd

Investigators

Principal Investigator:

Russell K Portenoy, MD

Beth Israel Medical Center

More Information

No publications provided by Archimedes Development Ltd

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Taylor D, Galan V, Weinstein SM, Reyes E, Pupo-Araya AR, Rauck R; Fentanyl Pectin Nasal Spray 043 Study Group. Fentanyl pectin nasal spray in breakthrough cancer pain. J Support Oncol. 2010 Jul-Aug;8(4):184-90.

Responsible Party:	Archimedes Development Ltd
ClinicalTrials.gov Identifier:	NCT00459277 History of Changes
Other Study ID Numbers:	CPO43/06/FCNS
Study First Received:	April 10, 2007
Last Updated:	January 20, 2012
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada; Costa Rica:Ministry of Health

Keywords provided by Archimedes Development Ltd:

Pain
Cancer

Additional relevant MeSH terms:

Citric Acid
Fentanyl
Analgesics, Opioid
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Chelating Agents
Molecular Mechanisms of Pharmacological Action
Adjuvants, Anesthesia

Central Nervous System Agents
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Intravenous
Anesthetics, General
Anesthetics

ClinicalTrials.gov processed this record on February 09, 2012