Breakthrough pain in opioid tolerant cancer patients.
Conditions
Interventions
Product Name: Fentanyl TAIFUN® 100 mcg/dose and 200 mcg/dose DPI
Pharmaceutical Form: Inhalation powder
INN or Proposed INN: Fentanyl Citrate
CAS Number: 990-73-8
Concentration unit: µg microgram(s)
C
Sponsors
Akela Pharma Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 18 years or older. 2. A medically documented diagnosis of cancer. 3. Use of a fixed around-the-clock dose of an opioid or a fixed combination of opioids as maintenance therapy for pain relief with a dose equivalent of at least 60 mg of oral morphine/day, or at least 25 µg of transdermal fentanyl/hour, or at least 30 mg of oral oxycodone daily or at least 8 mg of oral hydromorphone daily. Patients must be taking current opioid treatment for at least 7 days prior to the first dose of study medication. 4. Current use of medication for BTP. 5. At least one BTP episode per day with peak intensity of at least 4 on the numerical pain scale (NPS) at pain onset; no more than 4 BTP episodes per day. 6. The flow rate of inhalation of at least 20 L/min assessed by inspiratory flow meter (the highest of two readings will be used). 7. Karnofsky Performance Status 40 or better. 8. Written informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Uncontrolled or rapidly increasing BTP. 2. Symptomatic intracranial tumors or cerebral metastases. 3. Persistent, symptomatic asthma despite medication, as defined by daily symptoms, frequent exacerbations, frequent nocturnal asthma symptoms, predicted FEV1 = 60% or personal best PEFR = 60%. 4. Patients unable to use the inhaler (e.g. based on the use of training inhaler). 5. Inadequate lung function, as defined by PEFR < 60 %. 6. Hypersensitivities, allergies or contraindications to fentanyl or any compounds in the study medication. 7. A recent history of alcohol or substance abuse (in the past 1 year). 8. Chemotherapy with a drug not used before in this patient within 30 days of the beginning of the titration phase. 9. Radiotherapy to the thorax or the BTP target areas within 30 days of the beginning of the titration phase. 10. Cognitive impairment or any neurological or psychiatric disease which could compromise the ability of the patient to complete the assessments. 11. Participation in a prior clinical study with Fentanyl TAIFUN®. 12. Participation in any clinical study with experimental drug within 30 days of the study medication. 13. Any clinical condition (e.g. severe hepatic impairment) 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 (e.g. elderly or cachectic patient on the lowest dose of maintenance opioid therapy). 14. Pre-menopausal women (last menstruation < 1 year prior to the screening visit) who: - are not surgically sterile and/or - have a positive pregnancy test at baseline visit and/or - are of childbearing potential and are not practicing an acceptable means of birth control or do not plan to continue using this method throughout the study and/or are nursing.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to show that Fentanyl TAIFUN® treatment with a titrated, successful dose provides efficacious and fast pain relief without major safety concerns in cancer patients with breakthrough pain receiving maintenance opioid therapy. The primary efficacy evaluation will be based on the time-weighted sum of pain intensity difference up to 30 minutes (SPID30) and time to significant pain relief. Superiority of the investigational product compared to placebo will be shown. ;Secondary Objective: The secondary objectives are - to estimate the proportion of patients that can be titrated to an effective dose of Fentanyl TAIFUN® - to evaluate the efficacy of Fentanyl TAIFUN® through other secondary efficacy variables - to evaluate the safety of Fentanyl TAIFUN®, primarily through the adverse event profile;Primary end point(s): To show that Fentanyl TAIFUN® treatment with a titrated, successful dose provides efficacious and fast pain relief without major safety concerns in cancer patients with breakthrough pain receiving maintenance opioid therapy. | — |
Countries
Bulgaria, Czech Republic, Finland, Hungary
Outcome results
None listed