Patients with cancer having episodes of breakthrough pain MedDRA version: 7.1 Level: canc Classification code 10058019
Conditions
Interventions
Product Name: Fentanyl TAIFUN 100 µg/dose DPI
Product Code: F8101 (previous DE_MF_F8001)
Pharmaceutical Form: Inhalation powder
INN or Proposed INN: Fentanyl Citrate
CAS Number: 990-73-8
Current Spons
Sponsors
LAB Pharma Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Confirmed diagnosis of cancer 2. Age 18 years or more 3. Using a fixed dose of around-the-clock opioid or a combination of opioids for pain relief; either morphine 60-600mg/day, oxycodone 60-600 mg/day, methadone 15-200mg/day, transdermal fentanyl 25-300?g /hr or 12-120 mg/day hydromorphone, which has been stable for at least 5 days prior to the start of titration visit 4. Experiencing at least 1 episode of target breakthrough pain per day, which is responsive to short-acting opioid therapy 5. Written informed consent has been obtained 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 pain 2. Uncontrolled or rapidly increasing background pain 3. Intracranial tumours or cerebral metastases 4. Asthma 5. Inadequate lung function, as defined by PEFR <60% of age-adjusted normal, or any other valid method judged by the investigator appropriate 6. Radiotherapy to the thorax within 30 days of the start of titration visit 7. Chemotherapy with a drug not used before in this patient within 30 days of the registration visit 8. Planned surgery during the study period 9. Known allergy or hypersensitivity to any of the drugs under investigation or their components 10. Any known contraindications to any of the drugs under investigation 11. Alcohol or drug abuse 12. Participation in any clinical study within 1 month of the start of titration visit, with the only exception of the study FIND (EUDRACT No. 2004-001620-21) 13. Cognitive impairment or any neurological or psychiatric disease which could compromise the ability of the subject to complete the assessments 14. Any clinical condition which, in the opinion of the investigator would not allow safe completion of the study or safe administration of the study drug (e.g. elderly or cachectic patient on the lowest dose of background opioidi therapy). 15. Pre-menopausal women (last menstruation ?1 year prior to the screening visit) who: a. are not surgically sterile and/or b. have a positive pregnancy test at the randomisation visit and/or c. 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 d. are nursing
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the time to significant pain relief with Fentanyl TAIFUN® for patients with successful titration.;Secondary Objective: 1. To evaluate the proportion of subjects reaching successful titration. 2. To evaluate the time to effective titration. 3. To evaluate the dose of effective titration. 4. To evaluate the time to subjectively significant pain relief as indicated by the patient with Fentanyl TAIFUN®. 5. To evaluate the degree of pain relief with Fentanyl TAIFUN®. 6. To evaluate the proportion of episodes requiring rescue medication after titration 7. To evaluate the Global Performance of Fentanyl TAIFUN®. 8. To monitor the functionality and the impact of pain on patient’s life with the Brief Pain Inventory (BPI, short form) with Fentanyl TAIFUN®. 9. To evaluate the safety of Fentanyl TAIFUN®. Objective of the cross-over extension period: The primary and secondary objectives in the cross-over extension period are to compare Fentanyl TAIFUN with placebo in all applicable parameters mentioned above. ;Primary end point(s): The primary variable as given below will be measured for 5 episodes of breakthrough pain after successful titration. Each subject will be monitored for 5 episodes of “target” breakthrough pain. In addition, 6 additional episodes of “target” breakthrough pain will be monitored in the extension part of the study, for those subjects who have responded to the Fentanyl TAIFUN® treatment. Although, according to the prevailing approach in the clinical literature, each episode of breakthrough pain may be considered as independent,1, 9-11 in this study the primary variable will be derived from five episodes of target breakthrough pain occurring after titration, with the individual data of the five episodes used as an internal validity control as indicated in the statistical section (Analysis of efficacy). | — |
Countries
Finland
Outcome results
None listed