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 | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10058019 |
E.1.2 | Term | Cancer pain |
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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 confirm the efficacy of intranasal fentanyl (NAF) titrated to doses 50, 100 or 200 µg for treatment of breakthrough pain (BTP) in cancer patients - To establish long-term safety of treatment with NAF |
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E.2.2 | Secondary objectives of the trial |
- To explore the relationship between dose of background opioid treatment and titrated NAF dose |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
All inclusion criteria must be answered yes for a patient to participate in the trial. Inclusion criteria at screening 1. Has the patient given informed consent according to local requirements before any trial-related activities? Trial-related activities are any procedure that would not have been performed during the routine management of the patient 2. Is the patient a cancer patient with breakthrough pain? 3. Is the patient aged >=18 years? 4. Has the patient received for at least the past month either oral morphine, oxycodone, hydromorphone or transdermal fentanyl for treatment of background pain? 5. Is the current dose of the scheduled background opioid of the patient equivalent to 60-500 mg oral morphine/day or to transdermal fentanyl 25-200 µg/hour? 6. Is the background pain generally stable and on average controlled to a mild level (defined as <=4 on an 11 point NRS) by the background opioid?* 7. Is the BTP(s) in general of so severe pain intensity that the patient judges he/she needs additional analgesics (apart from background pain analgsics) and does it normally last for more than 15 minutes? 8. Does the patient in general while using a stable, fixed-schedule, opioid regimen have at least three BTP episodes per week but no more than four BTP episodes per day?* 9. Has the patient obtained at least partial relief of BTP(s) with his/her usual immediate-release strong opioid, i.e. oral morphine, oxycodone, hydromorphone or transmucosal fentanyl? 10. Is the patient able to use intranasal drugs? * If background pain and/or number of BTP episodes are too high, please continue screening after adjustment of background pain medication. For female patients of childbearing potential (Childbearing potential is considered until menopause has lasted more than 12 months. Surgically hysterectomised and surgically successfully sterilised females may be included on the same conditions as male patients). 11. Does the patient use adequate contraceptive precaution (contraceptive pill, implant or injection or intrauterine device) in the trial period? 12. Did the patient have a negative pregnancy test at the inclusion in studies FT-016-IM or FT-017-IM? |
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E.4 | Principal exclusion criteria |
All exclusion criteria must be answered no for a patient to participate in the trial. 1. Does the patient have a recent history of substance abuse? 2. Is the patient pregnant or nursing during the trial period? 3. Has the patient neurological or psychiatric impairment that may compromise data collection? 4. Has the patient severe hepatic impairment? (Investigators judgement according to local practice) 5. Has the patient had any recent therapy, which could potentially alter pain or response to analgesics to a degree, where the need for background opioid will be a. less than 60 mg morphine or morphine equivalents/day or b. less than 25 µg/hour transdermal fentanyl or the number of BTP episodes will be less than three per week during the trial period? 6. Has the patient had facial radiotherapy? 7. Has the patient been treated with MAO inhibitor within the last 14 days? 8. Does the patient use Methadone or Buprenorphine? 9. Does the patient have an impaired respiratory function to an extent, which may severely increase the risk of clinically relevant respiratory depression by BTP fentanyl treatment? 10. Does the patient use drugs for intranasal administration? 11. Does the patient have nasopharyngeal probe? 12. Is the patient known to be hypersensitive to fentanyl or to other opioids or any of their excipients? 13. Has the patient any head injury, primary brain tumour or other pathological conditions, which could significantly increase the risk of increased intracranial pressure or impaired consciousness? 14. Has the patient concomitant participation in any other trial with an investigational drug or device apart from cancer treatment and participation in NAF trials FT-016-IM/ FT-017-IM within 30 days prior to inclusion in this trial? 15. Does the patient have pathological conditions of the nasal cavity as contraindication to intranasal fentanyl? |
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E.5 End points |
E.5.1 | Primary end point(s) |
Pain intensity difference at 10 min (PID10) derived from PI scores |
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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 | Yes |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
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) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
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.8.5 | The trial involves multiple Member States | Yes |
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 | Information not present in EudraCT |
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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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 | 4 |
E.8.9.1 | In the Member State concerned days | |
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 | 4 |