Breakthrough cancer pain MedDRA version: 13.1 Level: PT Classification code 10058019 Term: Cancer pain System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Abstral
Product Name: Abstral
Pharmaceutical Form: Sublingual tablet
Sponsors
Orexo AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed informed consent obtained. 2. 18 years or older, of both genders. 3. Patients with cancer related pain, receiving fixed-schedule opioid regimen with any sustained release morphine (at least 60 mg daily) or oxycodone preparation (at least 30 mg daily) or transdermal fentanyl (at least 25µg per hour). 4. Patients who use immediate release morphine or oxycodone as rescue opioid drug. 5. Out-patients in palliative home care with a care giver, as a family member or in-hospital patients. 6. Patient, who in the opinion of the Investigator, is expected to experience episodes of BTcP 0.5-4 times a day. 7. Patient, who in the opinion of the Investigator, is likely to keep the rescue opioid dose fixed during baseline measurements i e during 21 days after screening. 8. Maximum PID30 standard deviation of 1.5 (as assessed by the webpage) during the baseline period. 9. P-value > 0.1 regarding the slope of the curve from the seven PID30 values (as assessed by the webpage) during the baseline period. 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. Already treated with SL fentanyl as rescue opioid within two weeks prior to screening. 2. Recent or planned therapy that would alter pain or responses to analgesics during the study according to Investigator judgement. 3. Severe obstructive lung disease including hypercapnia. 4. Active brain metastases with increased intracranial pressure. 5. Treatment with monoamine oxidase inhibitor < 14 days before or concurrent with SL fentanyl treatment. 6. Concurrent treatment with other significant CNS depressants according to investigator judgement. 7. Concurrent treatment with partial agonist /antagonist e.g. buprenorphine, nalbuphine and pentazocine. 8. Significant reduced liver and/or kidney function according to investigator judgement. 9. Significant prior history of substance abuse according to Investigator judgement. 10. Neurologic, psychiatric or cognitive impairment sufficient to compromise data collection according to Investigator judgement. 11. Pregnancy, breast feeding or woman of childbearing potential not using adequate birth control (e.g. IUD, barrier method, per oral contraceptive, hormone injections or implants). 12. Known hypersensitivity to any constituent of the study medication as specified in section 9.4.1.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: 1.To evaluate the responder rate in patients converted to sublingual fentanyl as assessed by the PID15. 2. To evaluate the ESAS. 3. To evaluate the patient's global assessment of treatment (patient satisfaction). 4. To evaluate the patient's preference of treatment. 5. To evaluate safety of treatment.;Primary end point(s): The primary endpoint is the response rate in patients converted to sublingual fentanyl. A subject is defined as responder if the change of Pain Intensity (PI) on the Numerical Rating Scale (NRS) rated from 0 to10, at 30 minutes (PID30) remains stable after the conversion compared to baseline. ;Main Objective: To evaluate the responder rate in patients converted to sublingual fentanyl as assessed by the PID30. | — |
Countries
Sweden
Outcome results
None listed