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
  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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ 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
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

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
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, see Learn About Clinical Studies.

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
NZOZ Recruiting
Wloclawek, Wolnosc, Poland, 4487-800
Contact: Zbigniew Kaczmarek, MD         
Sponsors and Collaborators
Akela Pharma, Inc.
  More Information

No publications provided

Responsible Party: Elvi Metsaranta, Akela Pharma
ClinicalTrials.gov Identifier: NCT00822614     History of Changes
Other Study ID Numbers: CL_700_014
Study First Received: January 12, 2009
Last Updated: January 13, 2009
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:
Hydromorphone
Fentanyl
Morphine
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotics
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics

ClinicalTrials.gov processed this record on July 29, 2014