Clinical Trials Register

Summary
EudraCT Number:	2019-003795-39
Sponsor's Protocol Code Number:	TKADEX
National Competent Authority:	Finland - Fimea
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2020-12-10
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

Finland - Fimea

A.2

EudraCT number

2019-003795-39

A.3

Full title of the trial

Premedication with intranasal dexmedetomidine in sedation of patients undergoing total knee arthroplasty (TKADEX) - a prospective, double blinded randomized controlled trial

Nenän kautta annosteltava deksmedetomidiini esilääkityksenä polven tekonivelleikkauksessa

A.3.1

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

Premedication with intranasal dexmedetomidine in sedation of patients undergoing total knee arthroplasty

Nenän kautta annosteltava deksmedetomidiini esilääkityksenä polven tekonivelleikkauksessa

A.3.2

Name or abbreviated title of the trial where available

TKADEX

A.4.1

Sponsor's protocol code number

TKADEX

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	Turku University Hospital
B.1.3.4	Country	Finland
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	Turku University Hospital
B.4.2	Country	Finland
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Turku University Hospital
B.5.2	Functional name of contact point	Division of Perioperative Services
B.5.3	Address:
B.5.3.1	Street Address	Kiinamyllynkatu 4-8
B.5.3.2	Town/ city	Turku
B.5.3.3	Post code	20521
B.5.3.4	Country	Finland
B.5.4	Telephone number	35823130000

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	Dexdor
D.2.1.1.2	Name of the Marketing Authorisation holder	Orion Corporation
D.2.1.2	Country which granted the Marketing Authorisation	Finland
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	Dexdor
D.3.2	Product code	N05CM18
D.3.4	Pharmaceutical form	Concentrate for solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intranasal use (Noncurrent)
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	Infusion
D.8.4	Route of administration of the placebo	Intranasal use (Noncurrent)

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Knee arthrosis

Polven nivelrikko

E.1.1.1

Medical condition in easily understood language

Knee arthritis

Polven nivelrikko

E.1.1.2

Therapeutic area

Diseases [C] - Musculoskeletal Diseases [C05]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.1
E.1.2	Level	LLT
E.1.2	Classification code	10031165
E.1.2	Term	Osteoarthritis knee
E.1.2	System Organ Class	100000004859

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

This study aims to determine if premedication with intranasal dexmedetomidine could provide sufficient sedation to alleviate anxiety
during total knee arthroplasty surgery.

E.2.2

Secondary objectives of the trial

We also want to find out if preoperatively given dexmedetomidine is effective analgesic adjuvant for treating postoperative pain in patients
undergoing elective knee arthroplasty.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. The patient is scheduled for elective unilateral total knee arthroplasty (TKA) under spinal anesthesia
2. Fluent skills in finnish language (to understand the given information and to be able to give informed consent and communicate with the study personnel)
3. Age between 35 and 80 years
4. Weight between 50 and 100 kg
5. ASA (American Society of Anesthesiologists) status 1-3
6. Written informed consent from the patient

E.4

Principal exclusion criteria

1. A previous history of intolerance to the study drug or related compounds and additives
2. Disease or condition affecting patient’s ability to give written informed consent
3. Existing or recent significant disease possible affecting absorption, distribution, metabolism, excretion or response to the study drug
4. History of cardiac disease (valvular insufficiency, severe left ventricular dysfunction) or abnormal ECG rhythm (bradycardia < 50/min, 2nd or 3rd degree AV-block, pacemaker)
5. Chronic opioid use or use of other analgesic adjuvants such as pregabalin, gabapentin, amitriptyline or duloxetine
6. Participation in any other study concomitantly or within one month prior to the entry into this study
7. Clinically significant abnormal findings in physical examination or laboratory screening
8. Use of drugs or natural products known to cause enzyme induction or inhibition
9. Pregnancy or breastfeeding
10. A previous intolerance to non-steroidal anti-inflammatory drugs (NSAIDs)
11. Preoperative systolic blood pressure <110mmHg

E.5 End points

E.5.1

Primary end point(s)

1. Postoperative pain measured with visual analogue score
2. Amount of additional intraoperative sedatives needed
3. Postoperative opioid consumption

E.5.1.1

Timepoint(s) of evaluation of this end point

1. Postoperative pain is recorded at the post-anesthesia care unit and at the ward regularly
2. Evaluation is performed when patient is transferred from operating room to post-anesthesia care unit
3. Cumulative opioid consumption is recorded from transfer to PACU to hospital discharge

E.5.2

Secondary end point(s)

1. Perioperative hemodynamics
2. Perioperative respiration
3. Patient satisfaction

E.5.2.1

Timepoint(s) of evaluation of this end point

1. Hemodynamic parameters recorded in the perioperative period
2. Respiratory parameters recorded in the preoperative period
3. Patient satisfaction will be assessed with a phone call 30 days after the procedure

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

Yes

E.6.5

Efficacy

Yes

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

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

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)

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

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

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

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2020-12-14

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2020-12-15

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

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