Breakthrough pain in opioid tolerant cancer patients MedDRA version: 11.0 Level: LLT Classification code 10064556 Term:
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: 990738
Concentration unit: µg microgram(s)
Con
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 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. Current opioid treatment for at least 7 days prior to the randomization. 4. Current use of opioid medication for BTP. 5. At least 4 episodes of BTP per Week 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. Life expectancy of at least 12 weeks. 9. 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 (based on investigator’s opinion). 5. Inadequate lung function, as defined by PEFR < 60 %. 6. Hypersensitivities, allergies or contraindications to fentanyl or the study medication components. 7. A recent history of alcohol or substance abuse (in the past 1 year). 8. Radiotherapy to the thorax within 30 days of the beginning of the titration phase. 9. Cognitive impairment or any neurological or psychiatric disease which could compromise the ability of the patient to complete the assessments. 10. Participation in any clinical study with an experimental drug within 30 days of the randomization. 11. 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). 12. 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 using reliable 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 objectives are •to ensure that Fentanyl TAIFUN® treatment with a titrated, successful dose is safe in repeated use for pain relief in cancer patients with breakthrough pain (BTP) receiving maintenance opioid therapy. The evaluation will be based on the adverse event (AE) profile and applicable safety measurements. •to characterize the safety of Fentanyl TAIFUN® treatment vs. the current BTP treatment based on the AE profile. ;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® with the titrated dose and the current BTP treatment with the confirmed dose •to evaluate patients’ preference between Fentanyl TAIFUN® and the baseline BTP medication •to evaluate the sustained analgesic effect of Fentanyl TAIFUN® and the current BTP treatment ;Primary end point(s): •to ensure that Fentanyl TAIFUN® treatment with a titrated, successful dose is safe in repeated use for pain relief in cancer patients with BTP receiving maintenance opioid therapy. The evaluation will be based on the adverse event (AE) profile and applicable safety measurements. •to characterize the safety of Fentanyl TAIFUN® treatment vs. the current BTP treatment based on the AE profile. | — |
Countries
Finland
Outcome results
None listed