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Safety of Fentanyl TAIFUN Treatment (FINDS)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2009 by Akela Pharma, Inc..
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00822614
First Posted: January 14, 2009
Last Update Posted: January 14, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Akela Pharma, Inc.
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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:


Further study details as provided by Akela Pharma, Inc.:

Primary Outcome Measures:
  • AE Profile [ Time Frame: 28 Days ]
  • To characterize the safety of Fentanyl TAIFUN treatment vs. the current BTP treatment based on the AE profile [ Time Frame: 28 days ]

Secondary Outcome Measures:
  • To estimate the proportion of patients taht can be titrated to an effective dose of Fentanyl TAIFUN [ Time Frame: 28 Days ]
  • To evaluate the efficacy of Fentanyl TAIFUN with the titrated dose and the current BTP treatment with the confirmed dose [ Time Frame: 28 Days ]
  • To evaluate patients's preference between Fentanyl TAIFUN and the baseline BTP medication [ Time Frame: 28 Days ]
  • To evaluate the sustained analgesic effect of Fentanyl TAIFUN and the current BTP treatment [ Time Frame: 28 Days ]

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
Other Names:
  • Fentanyl transdermal
  • Morphine Sulfate
  • Hydromorphone
  • Oxycodone
Experimental: Fentanyl TAIFUN
Titration for dose confirmation followed by observation period
Drug: Fentanyl TAIFUN
Inhalation of Fentanyl via TAIFUN inhaler

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
NZOZ Recruiting
Wloclawek, Wolnosc, Poland, 4487-800
Contact: Zbigniew Kaczmarek, MD         
Sponsors and Collaborators
Akela Pharma, Inc.
  More Information

Responsible Party: Elvi Metsaranta, Akela Pharma
ClinicalTrials.gov Identifier: NCT00822614     History of Changes
Other Study ID Numbers: CL_700_014
First Submitted: January 12, 2009
First Posted: January 14, 2009
Last Update Posted: January 14, 2009
Last Verified: January 2009

Keywords provided by Akela Pharma, Inc.:
Pain

Additional relevant MeSH terms:
Cancer Pain
Breakthrough Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Fentanyl
Hydromorphone
Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics