| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Adult hospice in-patients with terminal cancer who are thought to be in the last 1 - 2 weeks of life |
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| E.1.1.1 | Medical condition in easily understood language |
| Patients dying from cancer |
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| E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 20.0 |
| E.1.2 | Level | PT |
| E.1.2 | Classification code | 10059513 |
| E.1.2 | Term | Palliative care |
| E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
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| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 20.0 |
| E.1.2 | Level | LLT |
| E.1.2 | Classification code | 10048683 |
| E.1.2 | Term | Advanced cancer |
| E.1.2 | System Organ Class | 100000004864 |
|
| 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 |
We want to see how best to carry out a clinical trial to find out whether a medication known as fentanyl (given through the nose) given together with another medication known as midazolam (given through the lining of the mouth) are better (i.e. more effective) and faster at controlling the pain and agitation for patients dying in a hospice. The goal will be to use these medications for patients dying at home, leading to fewer nursing visits and lower healthcare costs.
We will assess the following:-
1. What is the time taken to control symptoms?
2. Did the patients need additional oral or injection medications?
3. How safe are the two medication when given together?
This is a pilot study meaning that we do not expect to have all answers to our research questions. It is to allow us to design a trial to confirm the trends we see in this trial. |
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| E.2.2 | Secondary objectives of the trial |
1. What is the time from recognition of symptoms to administration of drug?
2. What is the time from administration of drug to symptom control?
3. What is the duration of symptom relief?
4. What is the experience of carers who help patients with symptoms?
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| E.2.3 | Trial contains a sub-study | Yes |
| E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Both Version 20 1/1/14
1. An open label 2 stage randomised controlled trial comparing the use of PecFent ± Epistatus versus standard subcutaneous breakthrough medication for dying hospice patients who either remain in the hospice or go home.
2. A qualitative interview study to capture the thoughts of relatives of these patients about the use of these preparations.
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| E.3 | Principal inclusion criteria |
Pilot open label randomised controlled trial:
Adult hospice in-patients fitting the following criteria will be considered for inclusion. Where they have capacity they will be approached to see if they are willing to participate in the study.
If they lack capacity a carer / member of the family will be approached as a legal representative to see if they would consider giving consent on the patient’s behalf.
1. diagnosis of terminal cancer and thought to have an estimated prognosis of between 1 and 2 weeks
2. patients who, in the last 24 hours, have experienced at least one episode of breakthrough pain.
3. taking 60mg or more of oral morphine (or its equivalent) per 24 hours
4. have carers or family members who would be:
- willing to give the study medication to the patient
- likely to be at the hospice at least 25% of the time so that they are likely to be present to administer medication.
The contraceptive requirements are not applicable as the health status of patients is critical and predicted life span is short.
Qualitative Interview Study:
Family members / carers of a patient in the experimental arm of the open label randomised controlled trial, who has administered trial drug will be considered eligible to participate in the qualitative interviews.
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|
| E.4 | Principal exclusion criteria |
Pilot open label randomised controlled trial:
1. patients/ carers/ family members who will not agree to nasal or buccal drug application
2. patients / carers / family members who in the opinion of the clinical team would be too distressed by the idea of participation
3. patients with disease of the nasal/buccal mucosa preventing effective absorption of medication
4. families who are unable to administer breakthrough medication e.g. problems with dexterity
5. history of substance abuse – patient or carer / family.
6. patients with a previously known sensitivity to benzodiazepines and/or opioids
7. people who might not adequately understand verbal explanations or written information given in English. The feasibility study is only recruiting 20 patients and Gloucestershire has a only a very small percentage of people who are not English speaking. It has been decided that it is not cost effective to fund translation for this feasibility study although this information will have to be taken into account when planning a larger study. We will capture information on the numbers of patients that may have been excluded and the languages that might have been needed.
8. Participated in a palliative care trial within the last month.
Qualitative Interview Study:
Unable to understand sufficient English to take part in a semi-structured interview
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| E.5 End points |
| E.5.1 | Primary end point(s) |
1. time (in minutes) from need for breakthrough medication (recognition of symptom) to administration of drug.
2. need for additional oral or subcutaneous medication
3. safety analysis - safety assessments will include adverse event monitoring
|
|
| E.5.2 | Secondary end point(s) |
1. Time (minutes) to onset – when patient comfort began to improve from need for breakthrough medication (recognition of symptom) according to patient (where possible), relatives and staff (median time with interquartile range)
2. Time (minutes) from need for breakthrough medication (recognition of symptom) to administration of drug (median time with interquartile range)
3. Pain and symptom severity with relation to:
- duration of relief (median time with interquartile range)
- extent of relief (median pain and symptom severity scores at 5, 10, 15, 20, 25 and 30 minutes using the Visual Analogue Scales for 1 episode per day)
- comfort (median daily modified POS-S score) (with interquartile range) according to patient (where possible), relatives and staff
4. Time (minutes) to recurrence of symptoms (median time with interquartile range)
5. Proportion requiring PecFent, Epistatus or combination (or equivalent SANM)
6. Proportion requiring rescue medication
7. Total number of doses (for PecFent+Epistatus or equivalent SANM) administered per day
8. The frequency of PecFent+Epistatus (or equivalent SANM) administration per day
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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 | Yes |
| E.6.4 | Safety | No |
| E.6.5 | Efficacy | No |
| 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 | No |
| 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 | Yes |
| 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 | No |
| 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.8.2.4 | Number of treatment arms in the trial | 2 |
| E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
| E.8.4 | The trial involves multiple sites in the Member State concerned | No |
| E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
| E.8.5 | The trial involves multiple Member States | No |
| 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 | No |
| 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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| 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 |
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