Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
500 participants
INTERVENTIONAL
2008-12-31
2010-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Active Comparator
Current BTP Medication
Opioid
Current optimized BTP treatment
Fentanyl TAIFUN
Titration for dose confirmation followed by observation period
Fentanyl TAIFUN
Inhalation of Fentanyl via TAIFUN inhaler
Interventions
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Fentanyl TAIFUN
Inhalation of Fentanyl via TAIFUN inhaler
Opioid
Current optimized BTP treatment
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Akela Pharma, Inc.
INDUSTRY
Responsible Party
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Akela Pharma
Locations
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NZOZ
Włocławek, Wolnosc, Poland
Countries
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Central Contacts
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Facility Contacts
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Zbigniew Kaczmarek, MD
Role: primary
Other Identifiers
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CL_700_014
Identifier Type: -
Identifier Source: org_study_id
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