Safety of Fentanyl TAIFUN Treatment - Full Text View

Sponsor:	Akela Pharma, Inc.
Information provided by:	Akela Pharma, Inc.
ClinicalTrials.gov Identifier:	NCT00822614

Purpose

A Multicenter, Multinational, Randomized, Open-Label, Parallel-Group Trial to Evaluate hte Safety of Fentanyl TAIFUN Treatment after titrated Dose Administration and the Current Breakthrough Pain Treatment for Breakthrough Pain in Cancer Patients on Maintenance Opioid Therapy

Condition	Intervention	Phase
Breakthrough Cancer Pain	Drug: Fentanyl TAIFUN Drug: Opioid	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study
Official Title:	The Safety of Fentanyl TAIFUN Treatment After Titrated Dose Administration and the Current Breakthrough Pain Treatment for 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 Akela Pharma, Inc.:

Primary Outcome Measures:

AE Profile [ Time Frame: 28 Days ] [ Designated as safety issue: Yes ]
To characterize the safety of Fentanyl TAIFUN treatment vs. the current BTP treatment based on the AE profile [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To estimate the proportion of patients taht can be titrated to an effective dose of Fentanyl TAIFUN [ Time Frame: 28 Days ] [ Designated as safety issue: No ]
To evaluate the efficacy of Fentanyl TAIFUN with the titrated dose and the current BTP treatment with the confirmed dose [ Time Frame: 28 Days ] [ Designated as safety issue: No ]
To evaluate patients's preference between Fentanyl TAIFUN and the baseline BTP medication [ Time Frame: 28 Days ] [ Designated as safety issue: No ]
To evaluate the sustained analgesic effect of Fentanyl TAIFUN and the current BTP treatment [ Time Frame: 28 Days ] [ Designated as safety issue: No ]

Estimated Enrollment:	500
Study Start Date:	December 2008
Estimated Study Completion Date:	January 2010
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Active Comparator Current BTP Medication	Drug: Opioid Current optimized BTP treatment
Fentanyl TAIFUN: Experimental Titration for dose confirmation followed by observation period	Drug: Fentanyl TAIFUN Inhalation of Fentanyl via TAIFUN inhaler

Eligibility

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

Criteria

Inclusion Criteria:

Age 18 Years or older
A medically documented diagnosis of cancer
Use of a fixed round the clock dose of opioid as maintenance therapy with a dose equivalence of at least 60mg of oral morphine/ day, or at least 25 mcg of transdermal fentanyl/ hour, or at least 30 mg of oral oxycodone daily, or at least 8 mg of oral hydromorphone daily. Current opioid treatment for at least 7 days prior to randomization
Current use of opioid medication for BTP
At least 4 episodes of BTP per week, with peak intensity of at least 4 on the NPS at pain onset. No more than 4 BTP episodes per day.
PIFR of at least 20L/min
Karofsky Performance Status of 40 or better
Life expectancy of at least 12 weeks
Written Informed Consent

Exclusion Criteria:

Uncontrolled or rapidly increasing BTP
Symptomatic intracranial tumors or cerebral metastases
Persistent symptomatic asthma
Patients unable to use the inhaler
Inadequate lung function, as defined by PEFR <60%
Hypersensitivities, allergies or contraindications to fentanyl or the study medication components
A recent history of alcohol or substance abuse (in the past 1 year)
Radiotherapy to the thorax within 30 days of the beginning of the titration phase
Cognitive impairment or any neurological of psychiatric disease which could compromise the ability of the patient to complete the assessments
Participation in any clinical study with an experimental drug within 30 days of randomization
Any clinical condition or medical history which, in the opinion of the investigator would not allow for the safe completion of the study or the safe administration of the study drug
Pre-menopausal women who are not surgically sterile and/or have a positive pregnancy test at baseline visit and/ or are of child bearing potential and are not using a reliable method of birth control or do not plan to continue using this method throughout the study and/or who are nursing

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00822614

Contacts

Contact: Donna J Fordham	941 742 6585	fordhamd@akelapharma.com
Contact: Ed E Margerrison, PhD	512 517 9610	margerrisone@akelapharma.com

Locations

Poland, Wolnosc
NZOZ	Recruiting
Wloclawek, Wolnosc, Poland, 4487-800
Contact: Zbigniew Kaczmarek, MD

Sponsors and Collaborators

Akela Pharma, Inc.

More Information

No publications provided

Responsible Party:	Akela Pharma ( Elvi Metsaranta )
Study ID Numbers:	CL_700_014
Study First Received:	January 12, 2009
Last Updated:	January 13, 2009
ClinicalTrials.gov Identifier:	NCT00822614 History of Changes
Health Authority:	United States: Food and Drug Administration; Finland: Finnish Medicines Agency; Poland: Ministry of Health; India: Directorate General of Health Services (Drugs Control Section)

Keywords provided by Akela Pharma, Inc.:

Pain

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 February 08, 2010