E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 13.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10058019 |
E.1.2 | Term | Cancer pain |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate the responder rate in patients converted to sublingual fentanyl as assessed by the PID30. |
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E.2.2 | Secondary objectives of the trial |
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. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | 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.
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
Dose conversion (from immediate release oral opioids to Abstral) with subsequent dose titration. |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
single subject experimental design |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 6 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 10 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The end of the trial is the last visit (visit 3) of the last subject (according to the protocol). |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |