EUCTR2006-006678-12-BGActive, not recruitingNot Applicable
asal Transmucosal Fentanyl Citrate (NTFC) versus Oral Morphine Sulphate (OMS): A double-blind, double dummy, randomised, multi-centre, comparative cross-over study for the treatment of breakthrough pain in cancer patients
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 106
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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.
- •10. Safe contraception in women of childbearing potential throughout the entire study, which is defined as the use of effective birth-control methods such as condoms, diaphragms or intra-uterine devices, which are thought to be medically acceptable forms of birth control, or established treatment with hormonal contraceptives for at least 2 months prior to the first intake of study medication;
- •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) 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
- •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;
- •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)
Investigators
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