Long Term Safety Study of Nasalfent (Fentanyl Citrate Nasal Spray) for Treatment of Breakthrough Cancer Pain - Full Text View

Sponsor:	Archimedes Development Ltd
Information provided by (Responsible Party):	Archimedes Development Ltd
ClinicalTrials.gov Identifier:	NCT00458510

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 examine the long-term safety of Nasalfent in the treatment of breakthrough cancer pain.

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

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Supportive Care
Official Title:	An Open-Label Study Investigating Long-Term Safety and Tolerability of Fentanyl Citrate Nasal Spray in the Treatment of 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:

Long term Safety, tolerability and acceptability [ Time Frame: End of study ] [ Designated as safety issue: Yes ]

Enrollment:	403
Study Start Date:	January 2007
Estimated Study Completion Date:	February 2012
Primary Completion Date:	October 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Fentanyl, Open-Label treatment All patients take NasalFent at effective dose to treat up to four episodes of breakthrough cancer pain per day	Drug: Fentanyl (Nasalfent, Fentanyl Citrate Nasal Spray) treatment of up to 4 episodes of pain per day Other Name: FCNS

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 examine the long-term safety of Nasalfent treatment for breakthrough cancer pain.

After the study is completed, patients may continue to take medication if their doctor feels it is in the patient's best interest to do so. Safety information will continue to be collected during this period. Treatment may continue on study for as long as the patient requires treatment or until Nasalfent becomes commercially available.

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: NCT00458510

Sponsors and Collaborators

Archimedes Development Ltd

Investigators

Principal Investigator:

Russell K Portenoy, MD

Beth Israel Medical Center, New York, United States

More Information

No publications provided

Responsible Party:	Archimedes Development Ltd
ClinicalTrials.gov Identifier:	NCT00458510 History of Changes
Other Study ID Numbers:	CPO45/06/FCNS
Study First Received:	April 10, 2007
Last Updated:	January 6, 2012
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada; Czech Republic: State Institute for Drug Control; Costa Rica: Ministry of Health Costa Rica; France: Afssaps - French Health Products Safety Agency; Germany: Federal Institute for Drugs and Medical Devices; Italy: Ministry of Health; Netherlands: Medicines Evaluation Board (MEB); Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Spain: Ministry of Health; United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Archimedes Development Ltd:

Pain
Cancer
Breakthrough

Additional relevant MeSH terms:

Citric Acid
Fentanyl
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
Analgesics, Opioid

ClinicalTrials.gov processed this record on February 09, 2012