Clinical Trials Register

Summary
EudraCT Number:	2013-003790-10
Sponsor's Protocol Code Number:	1.0
National Competent Authority:	Austria - BASG
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2013-09-24
Trial results	View 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

Austria - BASG

A.2

EudraCT number

2013-003790-10

A.3

Full title of the trial

DEXMEDETOMIDINE FOR PERIPHERAL NERVE BLOCKADE: A DOSE-FINDING STUDY IN VOLUNTEERS

A.3.1

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

Dexmedetomidine (=Drug for Block Prolongation) used for Regionla Anaesthetic Blockade: A Dosefinding Study in Volunteers

A.3.2

Name or abbreviated title of the trial where available

Dose Finding Study for Dex

A.4.1

Sponsor's protocol code number

1.0

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	Medizinische Universität Wien, Universitätsklinik für Klinische Pharmakologie
B.1.3.4	Country	Austria
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	Medizinische Universität Wien
B.4.2	Country	Austria
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Medizinische Universität Wien
B.5.2	Functional name of contact point	Maya Keplinger
B.5.3	Address:
B.5.3.1	Street Address	Spitalgasse 23
B.5.3.2	Town/ city	Wien
B.5.3.3	Post code	1090
B.5.3.4	Country	Austria
B.5.4	Telephone number	00431404004100
B.5.5	Fax number	00431404004028
B.5.6	E-mail	maya.keplinger@meduniwien.ac.at

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	European Union
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	Dexmedetomidine
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	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Dexmedetomidine
D.3.9.1	CAS number	145108-58-3
D.3.9.3	Other descriptive name	DEXMEDETOMIDINE HYDROCHLORIDE
D.3.9.4	EV Substance Code	SUB20317
D.3.10	Strength
D.3.10.1	Concentration unit	µg/ml microgram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	100
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

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

24 Volunteers recieve an ultrasound guided ulnar nerve block, and apparted into 4 groups. Group 1 receives 3ml Ropivacaine 0.75% without adjuvants. Group 2-4 receives 3ml Ropivacain 0.75% with three different doses of dexmedetomidine (50, 100,150 mcg). The aim of the study is to eveluate the optimal dose regarding sensory duration of nerve block without side effects of dexmedetomidine.

E.1.1.1

Medical condition in easily understood language

Volunteers undergo a nerve block of the forearm. The study drug Dexmedetomidine is added in different doses to the local anaesthtetic to polong the blockade without side effects.

E.1.1.2

Therapeutic area

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

MedDRA Classification

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Duration of sensory block of the ulnar nerve

E.2.2

Secondary objectives of the trial

Onset time of sensory block of the ulnar nerve
Onset time and duration of motor blockade Vigilance status

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

*Healthy male volunteers aged between 18 and 45 years.
*BMI < 30 kg/m2
*Written informed consent given by volunteers after being provided with detailed information about the nature, risks, and scope of the clinical study as well as the expected desirable and adverse effects of the drug
*No legal incapacity and/or other circumstances rendering the volunteer unable to
understand the nature, scope and possible consequences of the study

E.4

Principal exclusion criteria

*Anatomical abnormalities of the forearm identified by physical examination *Use of NSAID during the last 2 weeks
*Known allergy or hypersensitivity to ropivacaine or other amino-amide LA
*Known allergy or hypersensitivity to dexmedetomidine
*Participation in another clinical study within the last 4 weeks prior to study *Coagulopathy
*Abnormalities in Blood pressure (Hypotension with a systolic BP < 90 mmHg and
hypertension with a systolic BP > 160 mmHg) after 5 min resting
*Bradycardia with a heart rate after 5 min resting of < 40 b/min
*Abnormalities in ECG that are considered clinically relevant like AV-block or
bradycardia
*Unreliability and/or lack of cooperation *Other objections to participate in the study in the opinion of the investigator

E.5 End points

E.5.1

Primary end point(s)

Demedetomidine ad an adjuvant prolongs the peripheral nerve blockade

E.5.1.1

Timepoint(s) of evaluation of this end point

Prior to Block, 2 min, 4 min, 6 min, 8 min, 10 min, 15 min, 20 min, 30 min, 60 min, after the block and then every 30 min until complete recovery.

E.5.2

Secondary end point(s)

*Duration of sensory and motor blockade
*Optimal dose with maximum prolongation without side effects

E.5.2.1

Timepoint(s) of evaluation of this end point

Prior to Block, 2 min, 4 min, 6 min, 8 min, 10 min, 15 min, 20 min, 30 min, 60 min, after the block and then every 30 min until complete recovery.

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

Yes

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)

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

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

Ropivacain in combination with or without Dexmedetomidine

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

When sensibility and motor function completeley recovered, the volunteer is able to be discharged. The volunteer has to come for a final visit within 1 week. After this meeting the study is finished.

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)

F.2 Gender

F.2.1

Female

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

Yes

F.3.2

Patients

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)

It is a voluntter study. No further treatment is necessary. If side effects occur there is either a medical doctor or a 24hours telephone hotline of the hospital available.

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

2013-10-23

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2013-10-10

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2013-12-24

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