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
Product Code: DE_MF_F8001
Pharmaceutical Form: Inhalation powder
INN or Proposed INN: Fentanyl Citrate
CAS Number: 990-73-8
Current Sponsor code: 5034697
Othe
Sponsors
LAB Pharma Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female Caucasian 2. Confirmed diagnosis of cancer 3. Age 18-75 4. Using a fixed dose of around-the-clock opioid for pain relief; either transdermal fentanyl 50-300 µg /hr, morphine 60-600 mg/day or oxycodone 60-600 mg/day which has been stable for at least 5 days prior to the randomisation visit. 5. Currently using short-acting opioid therapy for their breakthrough pain 6. Experiencing 1-4 episodes of breakthrough pain per day 7. 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 background pain 2. Cancer of the head, neck, pharynx or larynx 3. Intracranial tumours or cerebral metastases 4. Asthma 5. Unable to use the inhaler 6. Inadequate lung function, as defined by PEFR < 75% of age adjusted normal 7. Current smoker 8. Radiotherapy within 30 days of the randomisation visit 9. Chemotherapy within 5 days of the randomisation visit 10. Planned surgery during the study period 11. Known allergy or hypersensitivity to any of the drugs under investigation or their components 12. Any known contraindications to any of the drugs under investigation 13. Alcohol or drug abuse 14. Participation in any clinical study within one month of the randomisation visit 15. Neurological or psychiatric disease which could compromise the ability of the subject to complete the assessments 16. Any clinical condition which, in the opinion of the investigator would not allow safe completion of the study 17. 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: 1.To evaluate the degree of pain relief with Fentanyl TAIFUN® compared to placebo. 2.To evaluate the time to significant pain relief with Fentanyl TAIFUN® compared to placebo. ;Secondary Objective: 1. To evaluate the percentage of responders with Fentanyl TAIFUN® compared to placebo. 2. To evaluate the time to taking of rescue medication with Fentanyl TAIFUN® compared to placebo. 3. To evaluate the time to subjectively significant pain relief as indicated by the patient with Fentanyl TAIFUN® compared to placebo. 4. To evaluate the Global performance of Fentanyl TAIFUN® compared to placebo. 5. To evaluate the safety of Fentanyl TAIFUN® compared to placebo. ;Primary end point(s): 1. Degree of pain relief with Fentanyl TAIFUN ® will be evaluated as the derived variable, Sum of Pain Intensity Difference (SPID). Pain Intensity will be measured on a 0-10 Numerical Pain Scale (NPS). 2.Time to significant pain relief will be evaluated as the time needed in each episode for a decrease of at least 2 points on the NPS. | — |
Countries
Estonia, Finland, Italy, Latvia
Outcome results
None listed