Clinical trial NCT00822614: Safety of Fentanyl TAIFUN 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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Breakthrough Cancer Pain
Keywords: Pain
Lead sponsor: Akela Pharma, Inc.
Sponsor class: INDUSTRY
First posted: 2009-01-14
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: AE Profile
timeFrame: 28 Days
measure: To characterize the safety of Fentanyl TAIFUN treatment vs. the current BTP treatment based on the AE profile
timeFrame: 28 days
Secondary outcomes:
measure: To estimate the proportion of patients taht can be titrated to an effective dose of Fentanyl TAIFUN
timeFrame: 28 Days
measure: To evaluate the efficacy of Fentanyl TAIFUN with the titrated dose and the current BTP treatment with the confirmed dose
timeFrame: 28 Days
measure: To evaluate patients's preference between Fentanyl TAIFUN and the baseline BTP medication
timeFrame: 28 Days
measure: To evaluate the sustained analgesic effect of Fentanyl TAIFUN and the current BTP treatment
timeFrame: 28 Days
Other outcomes:
Locations:
city: Wloclawek
country: Poland
facility: NZOZ
state: Wolnosc
Study officials:
References: