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Safety of Fentanyl TAIFUN Treatment (FINDS)

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. Identifier: NCT00822614
Recruitment Status : Unknown
Verified January 2009 by Akela Pharma, Inc..
Recruitment status was:  Recruiting
First Posted : January 14, 2009
Last Update Posted : January 14, 2009
Information provided by:
Akela Pharma, Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Breakthrough Cancer Pain Drug: Fentanyl TAIFUN Drug: Opioid Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
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
Study Start Date : December 2008
Estimated Primary Completion Date : December 2009
Estimated Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. AE Profile [ Time Frame: 28 Days ]
  2. 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 :
  1. To estimate the proportion of patients taht can be titrated to an effective dose of Fentanyl TAIFUN [ Time Frame: 28 Days ]
  2. To evaluate the efficacy of Fentanyl TAIFUN with the titrated dose and the current BTP treatment with the confirmed dose [ Time Frame: 28 Days ]
  3. To evaluate patients's preference between Fentanyl TAIFUN and the baseline BTP medication [ Time Frame: 28 Days ]
  4. To evaluate the sustained analgesic effect of Fentanyl TAIFUN and the current BTP treatment [ Time Frame: 28 Days ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT00822614

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Contact: Donna J Fordham 941 742 6585
Contact: Ed E Margerrison, PhD 512 517 9610

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NZOZ Recruiting
Wloclawek, Wolnosc, Poland, 4487-800
Contact: Zbigniew Kaczmarek, MD         
Sponsors and Collaborators
Akela Pharma, Inc.
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Responsible Party: Elvi Metsaranta, Akela Pharma Identifier: NCT00822614    
Other Study ID Numbers: CL_700_014
First Posted: January 14, 2009    Key Record Dates
Last Update Posted: January 14, 2009
Last Verified: January 2009
Keywords provided by Akela Pharma, Inc.:
Additional relevant MeSH terms:
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Cancer Pain
Neurologic Manifestations
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General