Efficacy and Safety Study of Nasalfent for Treatment of Breakthrough Cancer Pain in Patients Taking Regular Opioids - Full Text View

Sponsor:	Archimedes Development Ltd
Information provided by:	Archimedes Development Ltd
ClinicalTrials.gov Identifier:	NCT00589823

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 painkiller 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 compared to Immediate Release Morphine Sulphate in the treatment of breakthrough cancer pain.

Condition	Intervention	Phase
Cancers, Pain	Drug: Fentanyl citrate Drug: Immediate release morphine sulphate	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 Multicentre, Double-Blind, Double-Dummy, Two-Phase Crossover Study of Fentanyl Citrate Nasal Spray Compared to Immediate Release Morphine Sulphate 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:

Pain Relief [ Time Frame: Various time points ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Pain Relief at various time points [ Time Frame: Various time points ] [ Designated as safety issue: No ]

Enrollment:	135
Study Start Date:	June 2007
Study Completion Date:	March 2009
Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 Immediate Release Morphine sulphate capsules taken at start of relevant BTCP episode. Each episode treated with either this medication OR the experimental comparator.	Drug: Fentanyl citrate nasal spray, 100, 200, 400 or 800 mcg dosage according to need, to treat up to four episodes of BTCP per day Other Names: FCNS Nasalfent
Experimental: 2 Nasalfent spray taken at start of relevant BTCP episode. Each episode to be treated with either this medication OR the active comparator (IRMS)	Drug: Immediate release morphine sulphate drug dose as required by patient taken to treat up to four epsiodes of BTCP per day Other Name: IRMS

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 many 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 Immediate Release Morphine Sulphate. The safety of the two treatment options 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: NCT00589823

Locations

United Kingdom
Prof Fallon
Edinburgh, United Kingdom

Sponsors and Collaborators

Archimedes Development Ltd

Investigators

Principal Investigator:

Marie Fallon

Western General Hospital, Edinburgh Cancer Centre

More Information

No publications provided

Responsible Party:	Mark Watling, Group Medical Director, Archimedes Development Ltd
ClinicalTrials.gov Identifier:	NCT00589823 History of Changes
Other Study ID Numbers:	CPO44/06/FCNS
Study First Received:	December 27, 2007
Last Updated:	January 20, 2010
Health Authority:	Czech Republic: Ethics Committee; Czech Republic: State Institute for Drug Control; 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; United Kingdom: Research Ethics Committee; India: Drugs Controller General of India

Keywords provided by Archimedes Development Ltd:

Pain
Cancer
Breakthrough

Additional relevant MeSH terms:

Fentanyl
Morphine
Analgesics, Opioid
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

ClinicalTrials.gov processed this record on February 09, 2012