Clinical Trials Register

Summary
EudraCT Number:	2011-002034-38
Sponsor's Protocol Code Number:	THL-04-11
National Competent Authority:	Denmark - DHMA
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2011-06-07
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

Denmark - DHMA

A.2

EudraCT number

2011-002034-38

A.3

Full title of the trial

Analgetisk effekt af perioperativ Escitalopram til patienter med højt præoperativt catastrophising-niveau ved total knæalloplastik: Et randomiseret, dobbeltblindet, placebokontrolleret studie

A.3.1

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

Smertelindring ved anvendelse af Escitalopram overfor placebo efter operation med indsættelse af et nyt knæled

A.4.1

Sponsor's protocol code number

THL-04-11

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	Rgshospitalet
B.1.3.4	Country	Denmark
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	Lundbeck Centre for fast-track hip and knee arthroplasty
B.4.2	Country	Denmark
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Hvidovre Hospital
B.5.2	Functional name of contact point	Dept. og anaesthesiology
B.5.3	Address:
B.5.3.1	Street Address	Kettegaard Allé 30
B.5.3.2	Town/ city	Hvidovre
B.5.3.3	Post code	2650
B.5.3.4	Country	Denmark
B.5.4	Telephone number	+4526250006
B.5.6	E-mail	lunn@dadlnet.dk

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Comparator
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	Cipralex
D.2.1.1.2	Name of the Marketing Authorisation holder	Lundbeck Pharma A/S
D.2.1.2	Country which granted the Marketing Authorisation	Denmark
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.3.1	Product name	Cipralex
D.3.2	Product code	33408
D.3.4	Pharmaceutical form	Capsule
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	Capsule
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

Postoperative smerter efter total knæalloplastik

E.1.1.1

Medical condition in easily understood language

Smerter efter operation hvor dere r foretaget en total udskiftning af knæledet

E.1.1.2

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	13.1
E.1.2	Level	LLT
E.1.2	Classification code	10036236
E.1.2	Term	Postoperative pain relief
E.1.2	System Organ Class	10042613 - Surgical and medical procedures

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Smerteniveau ved gang (5 meter) 24 timer postoperativt.

E.2.2

Secondary objectives of the trial

Smerteniveau ved gang (5 meter) og i hvile 2, 4, 6, 24, 28, 32, 48 timer samt morgen og aften 2.-6. postoperative dag. Der suppleres med udregning af kumulerede smertescorer (2-48 timer samt 2.-6. dag).
Supplerende analgetika (kumuleret opioidmængde) 0-48 timer og 2.-6. dage efter operation, registrering af eventuelle bivirkninger ved interview 48 timer postoperativt og 7. postoperative dag, vurdering af depressions- og angst-tendens og søvnkvalitet ved hjælp af spørgeskemaer (se under kliniske vurderinger) to dage før operation, 48 timer postoperativt samt 6. postoperative dag, samt Escitalopram-koncentration i venøs blodprøve 48 timer postoperativt.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Patienter indstillet til primær, elektiv, unilateral, TKA.
· Alder ³ 18 år og £ 80 år (både mænd og kvinder).
· Etniske danskere.
· Point-score på 21 point eller derover på Pain Catastrophising Scale.
· Patienter, som har givet deres skriftlige informerede samtykke til at deltage i undersøgelsen efter at have forstået denne.

E.4

Principal exclusion criteria

· Indtagelse af MAO-hæmmere, dopaminagonister, tramadol, triptaner, tryptophan, linezolid og naturlægemidler indeholdende perikon indenfor de sidste 6 måneder.
· Behandlingskrævende angst eller depressionsproblematik, herunder behandling med SSRI og/eller anden psykofarmaka indenfor de sidste 6 måneder.
· Bipolar affektiv sindslidelse i anamnesen.
· Behandling med glucocorticoider indenfor de sidste 6 måneder.
· Behandling med opioider (både stærke og svage) indenfor de sidste 4 uger.
· Alkoholmisbrug og/eller medicinmisbrug – efter investigators skøn.
· Aktuel malign lidelse i anamnesen.
· Kvinder i den fertile alder (mulig graviditet, amning).
· Epilepsi i anamnesen.
· AK-behandling.
· BMI > 40 kg / m2.
· Sygdom påvirkende central eller perifer nervefunktion (og dermed smerteperception) – efter investigators skøn.
· Demens eller anden kognitiv dysfunktion uforenelig med protokol gennemførsel – efter investigators skøn.
· Behandling med systemiske østrogenholdige hormonsubstituerende midler.
· Gastrointestinal blødning i anamnesen.
· Kendt lever- eller nyreinsufficiens.
· Allergi overfor Citalopram.

E.5 End points

E.5.1

Primary end point(s)

Smerteniveau ved gang (5 meter)

E.5.1.1

Timepoint(s) of evaluation of this end point

24 timer postoperativt.

E.5.2

Secondary end point(s)

Smerteniveau ved gang (5 meter)
og Supplerende analgetika (kumuleret opioidmængde)
registrering af eventuelle bivirkninger ved interview
vurdering af depressions- og angst-tendens og søvnkvalitet ved hjælp af spørgeskemaer (se under kliniske vurderinger)
samt Escitalopram-koncentration i venøs blodprøve 48 timer postoperativt.

E.5.2.1

Timepoint(s) of evaluation of this end point

i hvile 2, 4, 6, 24, 28, 32, 48 timer samt morgen og aften 2.-6. postoperative dag. Der suppleres med udregning af kumulerede smertescorer (2-48 timer samt 2.-6. dag).
0-48 timer og 2.-6. dage efter operation,

to dage før operation, 48 timer postoperativt samt 6. postoperative dag,
venøs blodprøve 48 timer

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

Yes

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)

Yes

E.7.4

Therapeutic use (Phase IV)

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

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

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

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

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial 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)

Yes

F.1.2.1

Number of subjects for this age range:

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

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

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

120

F.4.2

For a multinational trial

F.4.2.1

In the EEA

120

F.4.2.2

In the whole clinical trial

120

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

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	Neurobiological Research unit, Rigshospitalet
G.4.3.4	Network Country	Denmark

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

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2011-05-23

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2011-06-15

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2013-06-03

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