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

Sponsored by:	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 compated to Immediate Release Morphine Sulphate in the treatment of breakthrough cancer pain.

Condition	Intervention	Phase
Cancer Pain	Drug: Fentanyl Drug: Immediate release morphine sulphate	Phase III

MedlinePlus related topics: Cancer

Drug Information available for: Fentanyl Fentanyl Citrate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Crossover Assignment, Safety/Efficacy Study
Official Title:	A Multicentre, Double-Blind, Double-Dummy, Two-Phase Crossover Study of Nasalfent (Fentanyl Citrate Nasal Spray) Compared to Immediate Release Morphine Sulphate Tablets in the Treatment of Breakthrough Cancer Pain (BTCP) in Subjects Taking Regular Opioid Therapy

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 ]

Estimated Enrollment:	80
Study Start Date:	June 2007
Estimated Study Completion Date:	February 2009
Estimated Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Immediate Release Morphine sulphate capsules	Drug: Fentanyl nasal spray, 100, 200, 400 or 800 mcg dosage according to need
2: Experimental Nasalfent spray	Drug: Immediate release morphine sulphate drug dose as required by patient

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 groups 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	Recruiting
Edinburgh, United Kingdom
Contact: Marie Fallon 44 131 7773518 marie.fallon@ed.ac.uk

Sponsors and Collaborators

Archimedes Development Ltd

Investigators

Principal Investigator:

Marie Fallon

Western General Hospital, Edinburgh Cancer Centre

More Information

No publications provided

Responsible Party:	Archimedes Development Ltd ( Mark Watling, Group Medical Director )
Study ID Numbers:	CPO44/06/FCNS
Study First Received:	December 27, 2007
Last Updated:	January 12, 2009
ClinicalTrials.gov Identifier:	NCT00589823 History of Changes
Health Authority:	Czech Republic: Ethics Committee; Czech Republic: State Institute for Drug Control; Germany: Federal Institute for Drugs and Medical Devices; Italy: The Ministry of Health; The Netherlands: The Medicines Evaluation Board; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Spain: The Ministry of Health; United Kingdom: Medicines and Healthcare Products Regulatory Agency; UK: Research Ethics Committee; India: Drugs Controller General of India

Keywords provided by Archimedes Development Ltd:

Pain
Cancer

Study placed in the following topic categories:

Anesthetics, Intravenous
Morphine
Fentanyl
Citric Acid
Adjuvants, Immunologic
Anesthetics
Central Nervous System Depressants

Pain
Narcotics
Anesthetics, General
Analgesics
Peripheral Nervous System Agents
Analgesics, Opioid

Additional relevant MeSH terms:

Anesthetics, Intravenous
Morphine
Fentanyl
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Narcotics
Pharmacologic Actions

Adjuvants, Anesthesia
Anesthetics, General
Sensory System Agents
Therapeutic Uses
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on May 07, 2009