Cancer-related breakthrough pain MedDRA version: 12.1 Level: LLT Classification code 10064556 Term: Breakthrough pain
Conditions
Interventions
Product Name: Fentanyl nasal spray, solution 335 µg/ml
Pharmaceutical Form: Nasal spray, solution
INN or Proposed INN: FENTANYL CITRATE
CAS Number: 990738
Concentration unit: µg/ml microgram(s)/millil
Sponsors
Haupt Pharma Wolfratshausen GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males or females (aged at least 18 years, at the time of screening); 2. Patients with cancer related breakthrough pain 3. Being on stable transdermal fentanyl therapy equal to 25 – 200 µg/h or alternatively stable oral morphine therapy equal to 60 – 600 mg/day, or oral oxycodone therapy equal to 30 – 300 mg/day, or oral hydromorphone therapy equal to 8 – 80 mg/day for the treatment of chronic pain; 4. Breakthrough pain in general of such severe pain intensity that the patients needs additional analgesics (apart from persistent pain medication) 5. Experiencing at least 3 target breakthrough pain episodes per week 6. Achieving at least partial relief of the target breakthrough pains by oral opioid medication; 7. Patients able to use intranasal sprays; 8. Life expectancy of at least 3 month; 9. Written informed consent. Inclusion criteria limited to female patients only: 10. Female patients have to apply adequate contraceptive methods (e.g. implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner); 11. Women without childbearing potential such as women with hysterectomy or tubal ligation and post-menopausal women, the latter is defined as women who have had no menstruation for at least 2 years. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Safety concerns: 12. Hypersensitivities, allergies or contraindications to any compound in the present study medications or allergies to constituents of the pharmaceutical preparations; 13. Clinically relevant cardiopulmonary diseases that would increase the risk of taking potent opioids; 14. Evidence of clinically relevant increased intracranial pressure (e.g. brain metastases, head injuries) or impaired consciousness; 15. Current therapy with monoamine oxidase (MAO)-Inhibitors, or therapy with MAO-Inhibitors within the last 14 days 16. History of clinically relevant chronic obstructive pulmonary disease (COPD) or clinically relevant asthma bronchiale; 17. History of severe hepatic impairment that affects the safety of investigational products 18. Radionucleid therapy within the last 14 days; 19. Current radiotherapy or planned radiotherapy within the next 2 months; 20. Moderate or severe oronasal mucositis; 21. Clinically relevant brady-arrhythmias. 22. Malignant hypertension; 23. History of drug or alcohol abuse within the past 2 years; 24. Pregnant or nursing women or women of childbearing potential without an effective method of birth control (effective birth control methods are: intra-uterine device, surgical sterilisation, hysterectomy, oral contraceptive) 25. Frequent use of intranasal drugs that affects absorption 26. Participation in a clinical study during the last 6 weeks prior to the start of the study; Lack of suitability: 27. Uncontrolled or rapidly escalating pain; 28. Clinically relevant neurological or psychiatric disease that would compromise data collection; 29. Nasal obstruction or acute and chronic diseases of the nose or paranasal sinuses; 30. Nose and throat tumours that may alter the absorption of nasally applied fentanyl, the assessment of local tolerability or that may prevent from swallowing the capsules; 31. Clinically relevant allergic and non-allergic rhinitis; Administrative reasons: 32. Lack of ability or willingness to give informed consent; 33. Anticipated non-availability for study visits/procedures; 34. Vulnerable patients (e.g. person kept in detention)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to demonstrate non-inferiority of Nasal Transmucosal Fentanyl Citrate (NFTC) compared to Oral Morphine Sulphate (OMS); if non-inferiority can be demonstrated subsequently also superiority shall be demonstrated;Secondary Objective: efficacy of Nasal Transmucosal Fentanyl Citrate (NFTC) in comparison to Oral Morphine Sulphate (OMS) considering pain relief, satisfaction of the patients, and failure / rescue medication rate; safety and tolerability of NFTC compared to OMS;Primary end point(s): differences in pain intensity versus baseline at 15 an 30 min. after treatment | — |
Countries
Bulgaria, Czech Republic, Germany
Outcome results
None listed