E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
We will investigate the effect of regularly scheduled administration of paracetamol on Quality of life, daily functioning, care dependency, pain, change in challenging behaviour and antipsychotic medication use of long term care facility residents with moderate to severe dementia (of all types). |
We zullen het effect van op vaste tijdstippen toedienen van paracetamol onderzoeken op kwaliteit van leven, dagelijks functioneren, zorgafhankelijkheid, pijn, verandering in onbegrepen gedrag en antipsychotica gebruik bij verpleeghuisbewoners met matige tot (zeer) ernstige dementie (alle vormen). |
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E.1.1.1 | Medical condition in easily understood language |
Quality of life, daily functioning, care dependency, pain, change in challenging behaviour and antipsychotic medication use of long term care facility residents with moderate to severe dementia. |
Kwaliteit van leven, dagelijks functioneren, zorgafhankelijkheid, pijn, verandering in onbegrepen gedrag en antipsychotica gebruik bij verpleeghuisbewoners met matige tot (zeer) ernstige dementie. |
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E.1.1.2 | Therapeutic area | Not possible to specify |
MedDRA Classification |
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 | 10066844 |
E.1.2 | Term | Behavioral and psychiatric symptoms of dementia |
E.1.2 | System Organ Class | 100000171288 |
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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 effect of regularly scheduled administration of paracetamol on quality of life of long term care facility residents with moderate to (very) severe dementia. |
Het onderzoeken van het effect van op een vast tijdstip toedienen van paracetamol op kwaliteit van leven van verpleeghuisbewoners met matige tot (zeer) ernstige dementie. |
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E.2.2 | Secondary objectives of the trial |
To evaluate the effect of paracetamol treatment on daily function and care dependency, pain, change in challenging behaviour and antipsychotic medication use in long term care facility residents with moderate to (very) severe dementia. |
Het onderzoeken van het effect van paracetamol op dagelijks functioneren, zorgafhankelijkheid, pijn, verandering van onbegrepen gedrag en antipsychotica gebruik bij verpleeghuisbewoners met matige tot (zeer) ernstige dementie. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Diagnosis of dementia, Reisberg Global Deterioration Scale 5-7 Age 65 years or older QUALIDEM (Quality of life) score below the expected median score of 70) Not using any pain medication one week before start study. Residents with PRN prescribed paracetamol ("as needed") are also eligible, if the use of paracetamol in the last week was less than 3 grams/week. |
Diagnose dementie volgens Reisberg Global Deterioration Scale 5-7 Leeftijd 65 jaar en ouder QUALIDEM (Kwaliteit van leven) score onder de verwachte mediaanscore van 70 Geen gebruik van pijnmedicatie minimaal één week voor start studie. Patiënten die zo nodig paracetamol gebruiken mogen meedoen, indien zij niet meer dan 3 gram per week gebruikten in de laatste week voor de studie. |
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E.4 | Principal exclusion criteria |
• Presence of a severe psychiatric disorder • Severe liver insufficiency/disease • Use of >4 units alcohol per day • Allergy to study drugs • Concomitant use of flucloxacillin, carbamazepine, fenytoïne, fenobarbital, isoniazide and/or rifampicine • Weight <50 kg |
Aanwezigheid ernstige psychiatrische stoornis Ernstige leverinsufficiëntie/ziekte Gebruik van 4 of meer eenheden alcohol per dag Allergie voor studiemedicatie Gelijktijdig gebruik van flucloxacilline, carbamazepine, fenytoïne, fenobarbital, isoniazide en/of rifampicine Gewicht onder de 50 kg |
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E.5 End points |
E.5.1 | Primary end point(s) |
Difference in baseline quality of life (QUALIDEM-score) and follow-up scores |
Verschil in baseline kwaliteit van leven (QUALIDEM) score en follow-up scores |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
at Baseline at 6 weeks at 7 weeks at 13 weeks (end) |
op de baseline na 6 weken na 7 weken na 13 weken (einde) |
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E.5.2 | Secondary end point(s) |
• Neuropsychiatric symptoms of dementia • ADL functioning • Care dependency • Dementia severity • Pain • Medication use All measurements above will be taken at baseline and compared with follow-up scores |
Neuropsychiatrische symptomen dementie Dagelijks functioneren Zorgafhankelijkheid Ernst dementie Pijn (Antipsychotische) medicatie gebruik Alle metingen hierboven zullen op baseline worden gemeten en vergeleken worden met follow-up scores na 6, 7 en 13 weken. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
at Baseline at 6 weeks at 7 weeks at 13 weeks (end) |
op de baseline na 6 weken na 7 weken na 13 weken (einde) |
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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 | 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.8.2.4 | 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.8.5 | 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 | Yes |
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 | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |