Clinical Trials Register

Summary
EudraCT Number:	2017-000039-16
Sponsor's Protocol Code Number:	LUMC-PHEG-20172022
National Competent Authority:	Netherlands - Competent Authority
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2017-10-10
Trial results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Netherlands - Competent Authority

A.2

EudraCT number

2017-000039-16

A.3

Full title of the trial

Paracetamol to enhance quality of life and daily function and to decrease care dependency in advanced dementia: A randomized, double-blind, placebo-controlled crossover trial in long-term care facilities.

Paracetamol ter verbetering van kwaliteit van leven en dagelijks functioneren en ter vermindering van zorgafhankelijkheid bij mensen met (ver)gevorderde dementie: een gerandomiseerde, dubbelblinde, placebo-gecontroleerde crossover studie in Nederlandse verpleeghuizen.

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

A.3.2

Name or abbreviated title of the trial where available

Quality of life and Paracetamol In advanced Dementia (Q-PID trial)

Kwaliteit van leven en paracetamol bij mensen met matige tot (zeer) ernstige dementie (Q-PID-studie)

A.4.1

Sponsor's protocol code number

LUMC-PHEG-20172022

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Leiden University Medical Center
B.1.3.4	Country	Netherlands
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	ZonMW
B.4.2	Country	Netherlands
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Leiden University Medical Center
B.5.2	Functional name of contact point	Q-PID trial
B.5.3	Address:
B.5.3.1	Street Address	Albinusdreef 2 (V0-P)
B.5.3.2	Town/ city	Leiden
B.5.3.3	Post code	2333 ZA
B.5.3.4	Country	Netherlands
B.5.4	Telephone number	00310715268444

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Paracetamol
D.2.1.1.2	Name of the Marketing Authorisation holder	Teva Nederland BV
D.2.1.2	Country which granted the Marketing Authorisation	Netherlands
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Tablet
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

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).

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.

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

E.1.3

Condition being studied is a rare disease

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.

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.

E.2.3

Trial contains a sub-study

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.

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

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

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)

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.

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)

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

E.6.5

Efficacy

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

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

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

E.8.1.6

Cross over

Yes

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

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

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

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

LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

Yes

F.3.3.6.1

Details of subjects incapable of giving consent

Long term care facility residents with moderate to (very) severe dementia

Verpleeghuisbewoners met matige tot (zeer) ernstige dementie

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

None

Geen

G. Investigator Networks to be involved in the Trial
G.4 Investigator Network to be involved in the Trial: 1
G.4.1	Name of Organisation	University Network for Care sector Zuid-Holland (UNC-ZH)
G.4.3.4	Network Country	Netherlands

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2017-10-10

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2017-10-10

P. End of Trial
P.	End of Trial Status	Ongoing

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