Clinical Trials Register

Summary
EudraCT Number:	2014-002519-40
Sponsor's Protocol Code Number:	CHL.2/01-2014/M
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:	2015-07-07
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

2014-002519-40

A.3

Full title of the trial

A prospective, randomised, non-inferiority study of Chloroprocaine 2% and the active control Ropivacaine 0.75% (AstraZeneca) in ultrasound-guided axillary nerve block for short-duration distal upper limb surgery

Eine prospektive, randomisierte Nichtunterlegenheitsstudie zu Chlorprocain 2 % und der aktiven Kontrolle Ropivacain 0,75 % (AstraZeneca) für die ultraschallgesteuerte axilläre Plexus-brachialis-Blockade für Eingriffe an den distalen oberen Extremitäten mit kurzer Operationszeit

A.3.1

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

A study of Chloroprocaine 2% versus Ropivacaine 0.75% in ultrasound-guided axillary nerve anaesthesia for short-duration upper limb surgery of hand, wrist or forearm

A.3.2

Name or abbreviated title of the trial where available

Chloroprocaine 2% - Axillary block

Chlorprocain 2 % - Axillarisblock

A.4.1

Sponsor's protocol code number

CHL.2/01-2014/M

A.5.4

Other Identifiers

Name:

Study protocol

Number:

CRO-14-120

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	Sintetica S.A.
B.1.3.4	Country	Switzerland
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Sintetica S.A.
B.4.2	Country	Switzerland
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	CROSS Research S.A.
B.5.2	Functional name of contact point	Study Management
B.5.3	Address:
B.5.3.1	Street Address	Via F.A. Giorgioli
B.5.3.2	Town/ city	Arzo
B.5.3.3	Post code	6864
B.5.3.4	Country	Switzerland
B.5.4	Telephone number	0041(0)916300510
B.5.5	Fax number	0041(0)916300511
B.5.6	E-mail	corporate@croalliance.com

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	Ampres 20mg/ml solution injectable
D.2.1.1.2	Name of the Marketing Authorisation holder	Sintetica SA
D.2.1.2	Country which granted the Marketing Authorisation	Switzerland
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	Chloroprocaine HCl 2% (20 mg/mL)
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Perineural use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	CHLOROPROCAINE HYDROCHLORIDE
D.3.9.1	CAS number	3858-89-7
D.3.9.4	EV Substance Code	SUB01232MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	20
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.IMP: 2
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	Naropin, Ropivacaine HCl 0.75% (7.5 mg/mL)
D.2.1.1.2	Name of the Marketing Authorisation holder	AstraZeneca GmbH
D.2.1.2	Country which granted the Marketing Authorisation	Germany
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	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Perineural use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Ropivacainum
D.3.9.1	CAS number	132112-35-7
D.3.9.2	Current sponsor code	NA
D.3.9.3	Other descriptive name	ROPIVACAINE HYDROCHLORIDE MONOHYDRATE
D.3.9.4	EV Substance Code	SUB22590
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	7.5
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

Local anaesthesia by axillary nerve block

Lokalanästhesie durch axilläre Nervenblockade

E.1.1.1

Medical condition in easily understood language

Local anaesthesia by axillary nerve block

Lokalanästhesie durch axilläre Nervenblockade

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	19.1
E.1.2	Level	PT
E.1.2	Classification code	10024758
E.1.2	Term	Local anaesthesia
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

Non-inferiority evaluation of Test versus Reference product in terms of proportion of subjects with a successful block for distal upper limb surgeries, without any supplementation in the first 45 min (see definitions below), calculated from the time of readiness for surgery (complete sensory block).

Successful block: anaesthesia adequate for the surgery (complete sensory block), without any supplementation in the first 45 min (even if surgery lasts for > 45 min), calculated from the time of readiness for surgery (complete sensory block).
Supplementation: i.v. premedication or general anaesthesia or pre- or intra-operative systemic analgesia or additional local anaesthetic infiltration

Beurteilung des Testprodukts bezüglich der Nichtunterlegenheit gegenüber dem Referenzprodukt in Bezug auf den Anteil der Patienten mit erfolgreicher Blockade bei einem operativen Eingriff an den distalen oberen Extremitäten ohne Supplementierung in den ersten 45 Minuten (siehe Definitionen unten), gerechnet ab dem Zeitpunkt der Operationsfähigkeit (vollständige sensorische Blockade).

Erfolgreiche Blockade: Für den Eingriff geeignete Anästhesie (vollständige sensorische Blockade) ohne Supplementierung in den ersten 45 Minuten (selbst wenn der Eingriff länger als 45 Minuten dauert), gerechnet ab dem Zeitpunkt der Operationsfähigkeit (vollständige sensorische Blockade).

Supplementierung: Intravenöse Prämedikation oder Allgemeinanästhesie oder prä- bzw. intraoperative systemische Analgesie oder zusätzliche Infiltration eines lokalen Anästhetikums

E.2.2

Secondary objectives of the trial

Comparison between Test and Reference products in terms of the time to onset of sensory block [time to readiness for surgery], time to regression of sensory block, time to onset and regression of motor block, need for supplemental anaesthesia/analgesia and time to eligibility for home discharge; safety evaluation of the study treatments.

Vergleich zwischen Test- und Referenzprodukt im Hinblick auf die Zeit bis zum Einsetzen der sensorischen Blockade [Zeit bis zur Operationsfähigkeit], die Zeit bis zur Rückbildung der sensorischen Blockade, die Zeit bis zum Einsetzen und zur Rückbildung der motorischen Blockade, den Bedarf an ergänzender Anästhesie/Analgesie und die Zeit bis zur Entlassungsfähigkeit nach Hause; Beurteilung der Sicherheit der Studienbehandlungen.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Sex and surgery: male and female patients scheduled for short duration (< 60 min) distal upper limb surgery under axillary nerve block anaesthesia
2. Age: ≥ 18 years old
3. Body Mass Index (BMI): 18 - 32 kg/m2 inclusive
4. ASA physical status: I-III
5. Informed consent: signed written informed consent before inclusion in the study
6. Full comprehension: ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to co-operate with the investigator and to comply with the requirements of the entire study

1. Geschlecht und operativer Eingriff: Patientinnen und Patienten mit geplantem Eingriff an den distalen oberen Extremitäten mit kurzer Operationszeit (< 60 Minuten) unter axillärer Plexus-brachialis-Anästhesie
2. Alter: ≥ 18 Jahre
3. Body-Mass-Index (BMI): 18-32 kg/m2, jeweils einschliesslich
4. Körperlicher Zustand gemäss ASA-Klassifikation: I-III
5. Patientenaufklärung und Einwilligung: unterzeichnete schriftliche Einwilligungserklärung nach Aufklärung vor Einschluss in die Studie
6. Volles Verständnis: Fähigkeit, Art und Zweck der Studie in vollem Umfang zu verstehen, einschliesslich der möglichen Risiken und Nebenwirkungen; Fähigkeit zur Zusammenarbeit mit dem Prüfarzt und zur Erfüllung der Studienanforderungen

E.4

Principal exclusion criteria

1. Physical findings: clinically significant abnormal physical findings which could interfere with the objectives of the study. Contraindications to peripheral nerve block anaesthesia. History of neuromuscular diseases to the upper extremities
2. Axillary status: Axillary local infections, surgical scarring and pathological lymph node enlargement
3. ASA physical status: IV-V
4. Further anaesthesia: Patients anticipated to be requiring further anaesthesia (general or local anaesthesia)
5. Chronic pain syndromes: Patients with chronic pain syndromes (taking opioids, antidepressants, anticonvulsant agents)
6. Allergy: ascertained or presumptive hypersensitivity to the active principle and/or formulations ingredients; ascertained or presumptive hypersensitivity to the amide and ester-type anaesthetics
7. Diseases: significant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine or neurological diseases that may interfere with the aim of the study; ascertained psychiatric diseases, sepsis, blood coagulation disorders, insulin dependent diabetes mellitus, terminal kidney failure
8. Medications: Medication known to interfere with the extent of regional blocks (see chloroprocaine and ropivacaine SmPCs) for 2 weeks before the start of the study. Hormonal contraceptives for females will be allowed
9. Investigative drug studies: participation in the evaluation of any investigational product for 3 months before this study, calculated from the first day of the month following the last visit of the previous study
10. Drug, alcohol: history of drug or alcohol abuse
11. Pregnancy: missing or positive pregnancy test at screening, pregnant or lactating women

1. Körperliche Untersuchungsbefunde: Klinisch signifikante, abnorme körperliche Befunde, die die Studienziele beeinträchtigen können, Gegenanzeigen gegen periphere Nervenblockaden zur Anästhesie, neuromuskuläre Erkrankungen der oberen Extremitäten in der Vorgeschichte
2. Axillarer Status: Lokale Infektionen, Operationsnarben und pathologische Lymphknotenschwellung in der Axilla
3. Körperlicher Zustand gemäss ASA-Klassifikation: IV-V
4. Weitere Anästhesie: Patienten, die voraussichtlich weitere Anästhetika (Allgemein- oder Lokalanästhesie) benötigen
5. Chronische Schmerzsyndrome: Patienten mit chronischen Schmerzsyndromen (die Opioide, Antidepressiva oder Antikonvulsiva erhalten)
6. Allergie: Gesicherte oder angenommene Überempfindlichkeit gegenüber dem Wirkstoff und/oder anderen Inhaltsstoffen; gesicherte oder angenommene Überempfindlichkeit gegenüber Anästhetika vom Amid- und Ester-Typ
7. Erkrankungen: Anamnestisch bedeutende Nieren- oder Lebererkrankungen, Erkrankungen des Gastrointestinaltrakts, des Herz-Kreislauf-Systems oder der Atemwege, Hauterkrankungen, hämatologische, hormonelle oder neurologische Erkrankungen, die dem Ziel der Studie entgegen stehen können; gesicherte psychiatrische Erkrankungen, Sepsis, Blutgerinnungsstörungen, insulinabhängiger Diabetes mellitus, terminale Niereninsuffizienz
8. Arzneimittel: Verabreichung von Arzneimitteln, die bekanntermassen das Ausmass regionaler Blockaden
beeinträchtigen (siehe Zusammenfassung der Merkmale des Arzneimittels für Chlorprocain und Ropivacain) in den zwei Wochen vor Studienbeginn. Hormonale Kontrazeptiva für Frauen sind zulässig.
9. Studien mit in der Entwicklung befindlichen Substanzen: Teilnahme an einer anderen Studie zur Beurteilung eines Prüfpräparats in den drei Monaten vor der Studie, gerechnet ab dem ersten Tag des Monats nach dem letzten Termin im Rahmen der vorangegangenen Studie
10. Drogen, Alkohol: Drogen- oder Alkoholabusus in der Vorgeschichte
11. Schwangerschaft: Fehlender oder positiver Schwangerschaftstest bei der Voruntersuchung, Schwangere oder stillende Frauen

E.5 End points

E.5.1

Primary end point(s)

Proportion of patients with a successful block for distal upper limb surgeries, without any supplementation (i.e. no general anaesthesia or pre- and intra-operative systemic analgesia and no additional anaesthetic infiltration) in the first 45 min, calculated from the time of readiness for surgery (complete sensory block).

Anteil der Patienten mit erfolgreicher Blockade bei einem Eingriff an den distalen oberen Extremitäten ohne jede Supplementierung (d. h. keine Allgemeinanästhesie oder prä- bzw. intraoperative systemische Analgesie und keine zusätzliche Infiltration eines Anästhetikums) in den ersten 45 Minuten, gerechnet ab dem Zeitpunkt der Operationsfähigkeit (vollständige sensorische Blockade).

E.5.1.1

Timepoint(s) of evaluation of this end point

Successful block is defined as: anaesthesia adequate for the surgery (complete sensory block), without any supplementation in the first 45 min (even if surgery lasts for > 45 min), calculated from the time of readiness for surgery (complete sensory block).

Eine erfolgreiche Blockade ist definiert als eine für den chirurgischen Eingriff geeignete Anästhesie (vollständige sensorische Blockade) ohne jegliche Supplementierung in den ersten 45 Minuten (selbst bei einer Operationsdauer von > 45 Minuten), gerechnet ab dem Zeitpunkt der Operationsfähigkeit (vollständige sensorische Blockade).

E.5.2

Secondary end point(s)

Efficacy end-points:
- Time to onset of sensory block (corresponding to readiness for surgery),
- Time to onset of motor block,
- Time to regression of sensory block
- Time to regression of motor block,
- Time to administration of rescue anaesthesia or rescue analgesia,
- Time to first post-operative analgesia,
- Time to eligibility for home discharge.
Safety end-points:
Safety and general tolerability of the study treatments on the basis of treatment-emergent adverse events (TEAEs), neurological symptoms (e.g. paraesthesia, motor function problems and pain at the injection site), vital signs measurements (blood pressure, heart rate, oxygen saturation [SpO2]) and ECG recordings.

Wirksamkeitsendpunkte:
- Zeit bis zum Einsetzen der sensorischen Blockade (entsprechend der Operationsfähigkeit),
- Zeit bis zum Einsetzen der motorischen Blockade,
- Zeit bis zur Rückbildung der sensorischen Blockade,
- Zeit bis zur Rückbildung der motorischen Blockade,
- Zeit bis zur Verabreichung einer Notfallanästhesie oder Notfallanalgesie,
- Zeit bis zur ersten postoperativen Analgesie,
- Zeit bis zur Entlassungsfähigkeit nach Hause.
Sicherheitsendpunkte:
Sicherheit und allgemeine Verträglichkeit der Studienbehandlungen auf der Grundlage von unter der Behandlung auftretenden unerwünschten Ereignissen (treatment-emergent adverse events, TEAE), neurologische Symptome (z. B. Parästhesien, Probleme bei den motorischen Funktionen, Schmerzen an der Injektionsstelle), Messung der Vitalfunktionen (Blutdruck, Herzfrequenz, Sauerstoffsättigung [SpO2]) und EKG.

E.5.2.1

Timepoint(s) of evaluation of this end point

Sensory and motor blocks will be assessed every 5 min until the patient
is ready for surgery. Then, blocked limbs will be evaluated as soon as
possible after surgery (taking into consideration the end of the surgery
procedures), then every 15 min for the first hour after surgery, every 30
min for the next 2 hours and then every hour until regression of surgical
anaesthesia. Adverse Events will be evaluated throughout the study,
neurological symptoms will also be evaluated through an interview
using a specific questionnaire at final visit and at follow up.

Die Blockaden werden alle 5 Minuten beurteilt, bis der Patient
operationsfähig ist. Anschliessend werden die blockierten Extremitäten zum frühestmöglichen Zeitpunkt nach dem chirurgischen Eingriff (unter Berücksichtigung des Abschlusses der Operationsverfahren), in der ersten Stunde postoperativ dann alle 15 Minuten, in den nächsten beiden Stunden alle 30 Minuten und anschliessend stündlich bis zur Rückbildung der chirurgischen Anästhesie kontrolliert. Die Patienten werden über das Auftreten von Nebenwirkungen während der Studie in Frage gestellt werden. Neurologische Symptome werden auch in der postoperativen
Rekonvaleszenzphase, beim Abschlusstermin und Follow-up beurteilt.
Neurologische und andere Symptome werden in einem Interview mit
Hilfe eines speziellen Fragebogens beurteilt.

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

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)

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

Yes

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)

Yes

E.8.2.2

Placebo

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

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Austria

Switzerland

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

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:

150

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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2015-07-07.

Yes

F.3.3.2

Women of child-bearing potential using contraception

Yes

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

124

F.4.2

For a multinational trial

F.4.2.1

In the EEA

124

F.4.2.2

In the whole clinical trial

211

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)

The IMP is the anaesthetic administered for the placement of the axillary block for performing the scheduled short duration distal upper limb surgery. One single administration is foreseen before the surgery. After completion of the clinical trial, the participants will be treated according to the current state of the art therapy recommendations.

G. Investigator Networks to be involved in the Trial
G.4 Investigator Network to be involved in the Trial: 1

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

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2015-08-17

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2015-07-12

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2017-05-24

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IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
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