Safety of Fentanyl TAIFUN Treatment (FINDS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by Akela Pharma, Inc..
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Akela Pharma, Inc.
ClinicalTrials.gov Identifier:
NCT00822614
First received: January 12, 2009
Last updated: January 13, 2009
Last verified: January 2009

January 12, 2009
January 13, 2009
December 2008
December 2009   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00822614 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Safety of Fentanyl TAIFUN Treatment
The Safety of Fentanyl TAIFUN Treatment After Titrated Dose Administration and the Current Breakthrough Pain Treatment for Breakthrough Pain in Cancer Patients

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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Breakthrough Cancer Pain
  • Drug: Fentanyl TAIFUN
    Inhalation of Fentanyl via TAIFUN inhaler
  • Drug: Opioid
    Current optimized BTP treatment
    Other Names:
    • Fentanyl transdermal
    • Morphine Sulfate
    • Hydromorphone
    • Oxycodone
  • Active Comparator: Active Comparator
    Current BTP Medication
    Intervention: Drug: Opioid
  • Experimental: Fentanyl TAIFUN
    Titration for dose confirmation followed by observation period
    Intervention: Drug: Fentanyl TAIFUN
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
500
January 2010
December 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Donna J Fordham 941 742 6585 fordhamd@akelapharma.com
Contact: Ed E Margerrison, PhD 512 517 9610 margerrisone@akelapharma.com
Poland
 
NCT00822614
CL_700_014
No
Elvi Metsaranta, Akela Pharma
Akela Pharma, Inc.
Not Provided
Not Provided
Akela Pharma, Inc.
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP